>>WELCOME TO TODAY'S WEBINAR
FOR THE INCLUDE PROJECT.
LET'S TALK ABOUT CLINICAL
TRIALS.
MY NAME IS ERIKA TARVER, WE'RE
EXCITED TO HAVE YOU JOIN US
TODAY.
JUST A FEW HOUSEKEEPING RULES
BEFORE I TURN IT OVER TO DR.
LAURIE RYAN, IF YOU HAVE ANY
QUESTIONS OR WOULD LIKE ANY
QUESTIONS -- HAVE ANY QUESTIONS
FOR ANY SPEAKERS, PLEASE SUBMIT
THEM THROUGH THE Q&A OR THROUGH
THE CHAT FUNCTION.
WITHOUT FURTHER ADO I'LL TURN IT
OVER TO MY COLLEAGUE, DR. LAURIE
RYAN.
>>THANK YOU, ERIKA.
I'M WITH THE NATIONAL INSTITUTE
ON AGING AND INCLUDE PROJECT.
DR. PTOMEY IS ASSOCIATE
PROFESSOR, DEPARTMENT OF
INTERNAL MEDICINE, UNIVERSITY OF
KANSAS SMELL CENTER, REGISTERED
DIETITIAN, EXPERTISE
DISABILITIES INCLUDING DOWN
SYNDROME.
DR. PTOMEY HAS RECEIVED FIVE NIH
GRANTS AND PUBLISHED OVER 65
PEER-REVIEWED ARTICLES.
WELCOME, DR. PTOMEY.
>>THANK YOU.
THE BIG THING WE'RE GOING TO
BE TALKING ABOUT TODAY IS
CLINICAL TRIALS, WHAT THEY ARE,
WHY YOU MAY OR MAY NOT WANT TO
DO THEM, AND HOPEFULLY ANSWER
ANY QUESTIONS YOU MIGHT HAVE
ABOUT ENROLLING YOURSELF OR A
LOVED ONE WITH DOWN SYNDROME.
STARTING OFF WE'LL TALK ABOUT
WHAT IS CLINICAL RESEARCH FIRST.
WE'RE GOING TO GET INTO CLINICAL
TRIALS BUT THAT'S -- THERE'S AN
UMBRELLA TERM OVER EVERYTHING
ELSE, CALLED CLINICAL RESEARCH
THAT INCLUDES OBSERVATIONAL
STUDIES AND CLINICAL TRIALS.
WHEN SOMEONE SAYS RESEARCH
THERE'S A LOT OF DIFFERENT
THINGS THAT CAN BE TALKING
ABOUT.
IT CAN BE TALKING ABOUT CLINICAL
RESEARCH, WHICH IS ANY KIND OF
RESEARCH THAT INVOLVES PEOPLE.
YOU MIGHT SOMETIMES HEAR PEOPLE
TALK ABOUT BASIC RESEARCH OR
BASIC SCIENCE, WHICH TYPICALLY
INVOLVES ANIMALS OR CELLS OR
OTHER THINGS THAT AREN'T PEOPLE.
WITHIN THAT CLINICAL RESEARCH
UMBRELLA WE HAVE OBSERVATIONAL
STUDIES, SO THIS INCLUDE
EPIDEMIOLOGICAL STUDY WHICH
IMPROVES THE UNDERSTANDING OF
PATTERNS, CAUSES, EFFECTS OF
DISEASE.
HEALTH AND DISEASE.
WE ALSO HAVE -- CAN YOU DO
CROSS-SECTIONAL STUDY, YOU MIGHT
HAVE SOMEONE LOOK AT YOU AT ONE
POINT IN TIME, MAYBE LOOK AT
YOUR HEALTH, DIFFERENT OUTCOMES,
AND THEY USE THAT TO BE ABLE TO
HELP IDENTIFY HOW COMMON A
HEALTH CONDITION MIGHT BE,
FACTORS ASSOCIATED WITH IS, AND
A LONGITUDINAL COHORT STUDY
WHICH A LOT OF TIMES YOU COME IN
MULTIPLE TIMES.
SOMEONE WILL SEE WHERE ARE YOU
AT THAT TIME AND CAN HELP TO
DETERMINE LIKE WHEN YOU DEVELOP
A DISEASE AND WHAT MIGHT BE
RELATED TO THAT.
ON THIS OTHER SIDE WE HAVE
CLINICAL TRIALS.
THAT'S WHERE WE'RE REALLY GOING
TO SPEND MOST OF OUR TIME
TALKING TODAY.
SO, CLINICAL TRIALS ARE REALLY
THE HEART OF MEDICAL ADVANCES.
AND WHAT THEY ARE ARE LOOKING AT
NEW WAYS TO PREVENT, DETECT, OR
TREAT DISEASES.
A CLINICAL TRIAL IS WHEN YOU
COME IN AND YOU'RE ASSIGNED TO
DO SOMETHING.
YOU HAVE TO CHANGE SOMETHING.
WE LOOK AT HOW THAT CHANGE
AFFECTS YOUR HEALTH OVER TIME.
WE THINK ABOUT DRUG TRIALS,
PEOPLE WHO TRIED NEW DRUGS TO
HELP PREVENT A DISEASE OR
RECENTLY WITH ALL THE VACCINE
TRIALS WHERE VACCINES WERE
TESTED TO SEE IF THEY WORK.
CLINICAL TRIALS ARE NOT ALWAYS
DRUG TRIALS THOUGH.
FOR EXAMPLE, A LOT OF RESEARCH I
DO, A CLINICAL TRIAL LOOKS MORE
LIKE THIS, AN EXERCISE TRIAL
WHERE WE SEE HOW CAN WE GET
PEOPLE TO EXERCISE OR HELP
CHANGE HEALTH BEHAVIORS TO MAKE
A DIFFERENCE.
SO CLINICAL TRIALS EXAMINE A LOT
OF THINGS.
OF COURSE, THEY EXAMINE NEW
DRUGS, COMBINATION OF DRUGS FOR
DIFFERENT USES, YOU CAN ALSO
LOOK AT NEW WAYS OF DOING
SURGERY, USE OF NEW MEDICAL
DEVICE, NEW WAYS TO CHANGE YOUR
BEHAVIOR TO IMPROVE HEALTH, LIKE
PHYSICAL ACTIVITY, OR CHANGING
YOUR DIET OR TRYING TO HELP YOU
SLEEP BETTER.
AND YOU CAN LOOK AT NEW WAYS TO
IMPROVE THE QUALITY OF LIFE FOR
PEOPLE, WITH ACUTE OR CHRONIC
ILLNESS, NOT JUSTING A DRUG BUT
DOING OTHER THINGS.
THERE'S A WIDE SPECTRUM OF
CLINICAL TRIALS.
I THINK THE OTHER BIG QUESTION
IS WHY WOULD SOMEONE WANT DO A
CLINICAL TRIAL?
WHY WOULD YOU WANT TO DEVOTE
YOUR TIME AND ENERGY?
THERE'S A LOT OF REALLY GOOD
REASONS.
ONE, YOU CAN BE SOMEONE WHO
HELPS CONTRIBUTE TO MOVING
SCIENCE FORWARD WHICH MIGHT HELP
YOURSELF AND OTHERS.
THERE'S THE POSSIBILITY OF
RECEIVING NEWEST TREATMENT.
ESPECIALLY WITH DRUG TRIALS
YOU'LL BE ABLE TO GET
STATE-OF-THE-ART DRUGS BEFORE
THEY ARE AVAILABLE TO THE
POPULATION.
THERE'S THE CHANCE OF IMPROVING
YOUR HEALTH.
CLINICAL TRIALS ARE ONE OF THE
ONLY WAYS FOR RESEARCHERS TO
FIND TREATMENT FOR YOU AND
OTHERS.
AFTER A CLINICAL TRIAL WHEN WE
FIND GOOD THINGS IN RESEARCH WE
PUT THEM IN PRACTICE, HOW
DOCTORS GET RECOMMENDATIONS HOW
TO HELP YOU TREAT A DISEASE YOU
MIGHT HAVE OR DIFFERENT
CONDITION.
HOW WE KNOW THERE'S NEW DRUGS
THAT ARE SAFE AND EFFECTIVE FOR
TREATING DISEASES.
IT'S HOW WE LEARN WHAT HELPS
MAKE PEOPLE HEALTHIEST.
SO THEN WHY SHOULD YOU OR YOUR
LOVED ONE WITH DOWN SYNDROME
JOIN THE RESEARCH?
THIS IS REALLY IMPORTANT BECAUSE
TRADITIONALLY INDIVIDUALS WITH
DOWN SYNDROME HAVE BEEN EXCLUDED
FROM RESEARCH.
WHEN DOING A RESEARCH STUDY
THERE'S AN INCLUSION AND
EXCLUSION CRITERIA, THINGS WE
MUST HAVE TO ENROLL IN THE STUDY
OR IF YOU HAVE SOMETHING YOU
CAN'T BE IN THE STUDY.
TRADITIONALLY DOWN SYNDROME HAS
BEEN EXCLUSION CRITERIA, WE
DON'T KNOW IF SOMETHING THAT
WORKS IN THE GENERAL POPULATION
WILL WORK IN INDIVIDUALS WITH
DOWN SYNDROME.
STUDIES HAVE BEEN FOCUSED ON
SPECIFIC ISSUES LIKE REGRESSION,
AGING, ALZHEIMER'S.
ENROLLING IN RESEARCH STUDIES
ALLOWS RESEARCHERS AND DOCTORS
TO PROVIDE BETTER HEALTH CARE
FOR INDIVIDUALS WITH DOWN
SYNDROME AND HELP PREVENT OR
TREAT CONDITIONS RELATED TO DOWN
SYNDROME.
THIS IS REALLY IMPORTANT TO
CONTINUE TO IMPROVE QUALITY OF
LIFE MAKING SURE PEOPLE LIVE
LONGER.
SO HOW DOES THE CLINICAL TRIAL
PROCESS WORK?
SOMETIMES YOU'VE HEARD PEOPLE
RAMBLING THINGS ABOUT A PHASE 3
CLINICAL TRIAL OR PHASE 2,
ESPECIALLY IN THE LAST COUPLE
YEARS WHERE THEY HAVE BEEN DOING
LARGE VACCINE TRIALS.
BUT THE CLINICAL PROCESS IS
DIFFERENT.
WE'LL GO THROUGH THOSE.
IN CLINICAL TRIALS, THIS IS MORE
THE DRUG TRIALS.
YOU DO PRE-CLINICAL RESEARCH,
TYPICALLY CELL MODELS OR ANIMAL
MODEL MAL MODELS.
ONCE YOU HAVE AN IDEAS AND WANT
TO TEST IN HUMANS, YOU CAN DO A
PHASE 1 CLINICAL TRIAL, A SMALL
TRIAL IN ABOUT 20 TO 80 PEOPLE.
YOU JUST GIVE THEM THE DRUG THE
FIRST TIME AND LEARN IS IT SAFE,
ARE THERE HORRIBLE SIDE EFFECTS.
ONCE IT'S SHOWN TO BE PRETTY
SAFE, YOU GO TO A PHASE 2 TRIAL,
WHERE THOSE ARE GOING TO BE
BETWEEN 100 AND 300 PEOPLE.
THAT'S NOW SOMETIMES DONE A
LITTLE BIT LONGER, YOU ACTUALLY
START TO LOOK, OKAY, DOES THIS
DRUG WORK AND DO WHAT IT'S
SUPPOSED TO DO.
ALSO YOU CONTINUE TO TEST.
IS IT SAFE?
ARE THERE LONGTIME SIDE EFFECTS?
ONCE WE'VE SEEN THIS SEEMS DO
WHAT IT'S SUPPOSED TO BE AND BE
PRETTY SAFE WE MOVE TO PHASE 3
CLINICAL TRIALS.
SOME BIG ONES WE HEAR ABOUT IN
THE NEWS, SO THESE ARE ABOUT 1
THROUGH TO 3,000 PARTICIPANTS, A
LOT OF TIMES NATIONALLY AT
MULTIPLE SITES, ALL OVER THE
U.S.
THIS IS REALLY WHEN THE DRUG IS
GIVEN TO A LOT OF PEOPLE TO
CONFIRM IT DOES WORK, TO DO WHAT
IT'S SUPPOSED TO DO.
WE MONITOR SIDE EFFECTS, AND WE
COMPARE TO MAKE SURE IT'S BETTER
THAN MAYBE THE STANDARD
TREATMENT OR WHATEVER OTHER
DRUGS COULD HAVE BEEN OUT THERE
AT THE TIME.
AFTER THE RESULTS GO THROUGH, A
DRUG GOES TO FDA REVIEW WHERE
THEY GO THROUGH ALL THE RESULTS
IN THE STUDY, CONFIRM ITS SAFETY
AND EFFECTIVENESS, AND TYPICALLY
IT GETS APPROVED OR NOT
APPROVED.
ONCE APPROVED, STAGE 4, WHERE
WE'RE CONTINUOUSLY WATCHING IT,
MONITORING SAFETY, LOOKING AT
HOW IT'S WORKING, WHAT ARE
BENEFITS, SIDE EFFECTS.
A LOT OF TIMES IN PHASE 4 TRIALS
WE'LL SEE A DRUG PRESCRIBED FOR
ONE THING, MAYBE PRESCRIBED TO
HELP SEIZURE CONTROL, WE START
TO SEE SIDE EFFECTS MAYBE
HELPING PEOPLE SLEEP BETTER OR
DO SOME OTHER THINGS.
SO WE'LL START A NEW TRIAL, DOES
THIS DRUG ACTUALLY WORK FOR THAT
CONDITION AS WELL?
AND IT STARTS THE CYCLE OVER.
BEHAVIORAL RESEARCH IS
DIFFERENT.
TYPICALLY YOU START WITH BASIC
RESEARCH.
I'M GOING TO TALK ABOUT MY OWN
EXPERIENCE SINCE I'M A
BEHAVIORAL RESEARCHER, PHYSICAL
ACTIVITY.
FOR EXAMPLE, BASIC RESEARCH HAS
SHOWN PHYSICAL ACTIVITY IS GOOD.
AND WE NEED TO FIND WAYS TO HELP
PEOPLE GET MORE PHYSICAL
ACTIVITY IN.
SO WE WANT TO DEVELOP A PHYSICAL
ACTIVITY INTERVENTION THAT
PEOPLE WILL FOLLOW AND INCREASE
THEIR PHYSICAL ACTIVITY, AND WE
CAN SEE DOES IT DO ALL THESE
GOOD THINGS.
WE MIGHT DO STAGE 1 RESEARCH
FIRST, START TO DEVELOP
INTERVENTION, IT COULD BE
TALKING TO INDIVIDUALS TO SEE
BARRIERS AND SUPPORTS TO
PHYSICAL ACTIVITY.
IT MIGHT BE LOOKING AT
INTERVENTIONS THAT ALREADY EXIST
AND MODIFYING.
FOR EXAMPLE, MAYBE TAKING
GENERAL POPULATION AND REFINING
SPECIFIC FOR THE DOWN SYNDROME
POPULATION.
AND KIND OF CREATING A GENERAL
TEMPLATE.
STAGE 2 RESEARCH TESTS DOES THIS
WORK, IN A CONTROLLED SETTING.
THESE ARE DONE AT MEDICAL
CENTERS, CLOSELY MONITORED.
A LOT OF TIMES RESEARCH STAFF
WILL LEAD THE INTERVENTION.
YOU'LL COME IN FOR LAB-BASED
TESTING IN THE MEDICAL CENTER.
IT'S TIGHTLY, TIGHTLY
CONTROLLED.
ONCE IT'S WORKING WE DONE TO
STAGE 3 IN COMMUNITY CENTERS.
LET'S SAY WE DEVELOPED A
PHYSICAL ACTIVITY INTERVENTION,
EXCITED, HAVE SHOWN IF WE
DELIVER IN RESEARCH LAB IT SEEMS
TO WORK.
NOW WE'LL HAVE SPECIAL OLYMPICS
DELIVER THIS, IN THE SMALL
AMOUNT OF PEOPLE TESTING THIS
DOES IT SEEM TO WORK?
WE SEE IT DOES, THEY ARE GETTING
MORE ACTIVITY IN.
YOU MOVE TO STAGE 4,
EFFECTIVENESS, WHERE WE'LL
COMPARE AGAINST THE STANDARD OF
TREATMENT.
MAYBE SPECIAL OLYMPICS HAD BEEN
DOING ONE PROGRAM, NOW THERE'S A
NEW ONE THAT MIGHT BE BETTER.
WE'LL MAYBE CREATE A RANDOMIZED
TRIAL, RANDOMIZED TO DO THE OLD
PROGRAM OR NEW ONE.
WE SEE DOES THIS WORK BETTER?
WE MOVE INTO IMPLEMENTATION
DISSEMINATION WHERE WE MAKE THE
PHYSICAL ACTIVITY INTERVENTION,
WHATEVER BEHAVIOR, STANDARD OF
CARE, WORK TO INCORPORATE IT
INTO THE DIFFERENT COMMUNITY
AGENCIES, HOSPITALS, ACROSS KIND
OF THE NATION, INCORPORATING
INTO POLICY AND GETTING IT OUT
THERE FOR AS MANY PEOPLE AS
POSSIBLE.
ONE OF THE GOOD EXAMPLES IS THAT
YOU'VE HEARD OF THE DIABETES
PREVENTION PROGRAM.
THIS WAS LOOKING TO SEE CAN WE
PREVENT TYPE 2 DIABETES.
NOW IT'S A POLICY AND THERE'S
PEOPLE ACROSS THE NATION
EVERYWHERE THAT CAN GET APPROVED
TO DELIVER THIS.
AND MAKING IT REALLY ACCESSIBLE.
SO, ONE THING YOU MIGHT BE
ASKING, ARE CLINICAL TRIALS
SAFE?
AND THE ANSWER IS YES AND NO,
BUT FOR THE MOST PART YES.
THERE ARE MANY ETHICAL
GUIDELINES AND PROCEDURES IN
EFFECT TO PROTECT INDIVIDUALS.
ALMOST ALL ARE APPROVED AND
MONITORED BY AN INTUITIONAL
REVIEW BOARD, TO ENSURE THAT THE
RISK OF THE STUDY IS MINIMAL
COMPARED WITH BENEFITS.
A LOT OF TIMES A BENEFIT/RISK
RATIO.
IF WE SEE SOMETHING WITH A LOT
OF RISK AND VERY LITTLE BENEFIT
IT'S PROBABLY NOT GOING TO GET
APPROVED.
THIS BOARD IS MADE UP OF
DOCTORS, SCIENTISTS,
STATISTICIANS, EVEN MEMBERS OF
THE COMMUNITY WHO GIVE INPUT,
DOES THIS SEEM SOMETHING SAFE,
IT'S OKAY TO HAVE PEOPLE DO?
THESE IRBs GIVE EXTRA
PROTECTION WHEN RESEARCH
INCLUDES INDIVIDUALS WITH DOWN
SYNDROME.
IT'S DONE TO MAKE SURE THEY ARE
NOT BEING TAKEN ADVANTAGE OF AND
THEIR HEALTH AND SAFETY IS PUT
VERY HIGH.
SO, THE OTHER THING, RESEARCHERS
ARE REQUIRED TO TELL YOU ALL OF
THE RISK OF A STUDY BEFORE YOU
ENROLL.
THEY WILL ALSO TELL YOU HOW THEY
ARE GOING TO TRY TO PROTECT YOU
FROM RISKS.
AND THEY HAVE TO KEEP YOU
UPDATED IF ANY OF THOSE RISKS
EVER CHANGE.
YOU'LL KNOW GOING IN KIND OF
WHAT YOUR RISKS ARE, HOW SAFE IT
MIGHT BE.
AND YOU CAN MAKE THAT DECISION
YOURSELF THAT'S SOMETHING YOU'RE
WILLING TO DO.
SO DO THE BENEFITS OUTWEIGH THE
RISK?
NOW I'M GOING TO WALK THROUGH
WHAT THE RESEARCH PROCESS LOOKS
LIKE.
SOME STUFF WE MIGHT NOT
UNDERSTAND NOW BUT I HAVE SLIDES
TO GO THROUGH AND CLARIFY EACH
OF THESE POINTS.
LET'S SAY YOU HEAR ME TALKING,
OKAY, MAYBE RESEARCH SOUNDS LIKE
SOMETHING I WANT TO DO.
YOU'LL GO OUT AND FIND A
RESEARCH STUDY, YOU OR YOUR
LOVED ONE MIGHT QUALIFY FOR.
WE'LL GO OVER HOW DO THAT IN A
BIT.
YOU CONTACT THE TEAM AND TELL
THEM YOU'RE INTERESTED.
TRADITIONALLY THEY WILL ASK YOU
SOME QUESTIONS, HAVE YOU FILL
OUT A FORM, TO MAKE SURE YOU
MADE MEET INCLUSION OR EXCLUSION
CRITERIA THAT SAYS YOU CAN BE IN
IT, MAKING SURE YOU DON'T MEET
ANYTHING THAT SAYS YOU CAN'T BE
IN IT STUDY.
THEY WILL TELL YOU MORE, WHAT IT
ENTAILS, START GOING OVER RISKS
AND BENEFITS.
IF YOU DECIDE THIS IS SOMETHING
YOU'RE INTERESTED IN, AND
QUALIFY FOR, YOU MOVE FORWARD, A
CONSENT FORM, YOU'LL SIGN AND
ENROLL AT LEAST INITIALLY IN
SCREENING.
AFTER THAT A LOT OF STUDIES HAVE
A PRE-SCREENING ASSESSMENT.
MAYBE DO CONFIRMATORY
ASSESSMENTS WHERE YOU COME IN OR
OTHER THINGS WHERE THEY WILL
COLLECT DATA JUST TO MAKE SURE,
AGAIN, THAT YOU MEET THE
INCLUSION AND EXCLUSION
CRITERIA.
OR SOMETIMES YOU JUST GO IN,
STRAIGHT FOR BASELINE TESTING,
THAT MEANS ORIGINAL TIME, WE'LL
SEE WHERE YOUR HEALTH IS, WHERE
ALL THESE OUTCOMES WE MIGHT BE
INTERESTED IN ARE BEFORE
STARTING ANY KIND OF
INTERVENTION.
AFTER THAT YOU'RE NORMALLY
RANDOMIZED, WHICH WE'LL GO OVER
WHAT THAT IS, TO TWO OR MORE
CONDITIONS.
SO THIS IS A FIGURE DOWN HERE,
YOU HAVE THIS RANDOMIZATION
WHERE YOU'RE PLACED IN A GROUP.
YOU MIGHT BE PLACED TO GET THIS
TREATMENT GROUP, MAYBE TESTING
OUT THE NEW TREATMENT OR NEW
DRUG OR NEW INTERVENTION THAT WE
WANT TO LOOK AT.
AND THEN THE CONTROL GROUP,
WHICH IS TRADITIONALLY THE
STANDARD OF CARE OR COULD BE
LIKE A PLACEBO DRUG.
SO, LET'S GO INTO DETAIL ABOUT
THESE THINGS.
INFORMED CONSENT.
WHAT IS THAT?
INFORMED CONSENT IS THE PROCESS
OF PROVIDING YOU CAN KEY
INFORMATION ABOUT A RESEARCH
STUDY BEFORE YOU DECIDE WHETHER
OR NOT TO TAKE PART IN IT.
THIS IS NORMALLY IN A WRITTEN
DOCUMENT.
IT WILL BE HANDED TO YOU BY THE
STUDY TEAM, OR NOW IN THE
POST-COVID AGE A LOT OF TIMES
THIS MIGHT BE ONLINE, LIKE A
DOCUSIGN WHERE YOU CAN DO IT
REMOTELY.
THE RESEARCH TEAM WILL READ WITH
YOU THE INFORMED CONSENT
DOCUMENT AND GO INTO DETAIL
ABOUT THE PURPOSE OF THE STUDY,
HOW LONG THE STUDY IS EXPECTED
TO LAST, WHAT YOU'RE ASKED TO DO
AND HOW LONG THOSE WILL LAST.
THEY WILL GIVE INFORMATION WHO
YOU CAN CONTACT FOR FURTHER
INFORMATION.
AND THEY WILL GO OVER RISKS AND
BENEFITS.
YOU HAVE THE ABILITY TO DECIDE
WHETHER OR NOT TO SIGN THE
DOCUMENT OR ENROLL IN THE STUDY.
SOMETIMES YOU CAN TAKE A COUPLE
DAYS TO DECIDE, YOU DON'T HAVE
TO ALWAYS DO IT ON THE SPOT.
IF YOU WANT TO THINK ABOUT IT,
THAT'S OKAY.
ONE OF THE MOST IMPORTANT THINGS
TO KNOW IS TAKING PART IN A
CLINICAL TRIAL IS VOLUNTARY.
YOU CAN LEAVE A STUDY AT ANY
TIME.
MAYBE AT FIRST YOU THINK IT
SOUNDS GREAT AND YOU GET INTO IT
AND REALIZE YOU DON'T WANT TO DO
THIS ANYMORE.
IT'S OKAY TO LEAVE.
THERE'S NEVER REPERCUSSIONS FROM
LEAVING A STUDY.
WITH THAT, SOMEONE MIGHT ASK IS
SOMEONE WITH DOWN SYNDROME
ALLOWED TO SIGNED INFORMED
CONSENT AND ENROLL ON THEIR OWN?
THE ANSWER IS IT DEPENDS.
ANYONE UNDER THE AGE OF 18 OR
WHO IS NOT THEIR OWN LEGAL
GUARDIAN MUST HAVE THEIR LEGAL
GUARDIAN OR AUTHORIZED LEGAL
REPRESENTATIVE SIGN THE CONSENT
FORM ON THEIR BEHALF.
THIS INDIVIDUAL CAN SIGN AN
ASSENT FORM, A SMALLER VERSION
THAT THEY WILL SIGN.
YOU HAVE TO HAVE BOTH A CONSENT
AND ASSENT FORM DONE TO ENROLL
IN THE RESEARCH PROJECT.
THIS IS NICE BECAUSE IT PROTECTS
THE PERSON, FOR EXAMPLE, WITH
DOWN SYNDROME FROM BEING FORCED
TO ENROLL IN SOMETHING THEY
DIDN'T WANT TO, OR THAT THEY
DIDN'T UNDERSTAND.
SO YOU CAN'T HAVE, FOR EXAMPLE,
LET'S SAY A PARENT REALLY WANTS
THEIR CHILD TO BE IN THE PROGRAM
OR STUDY BUT THAT PERSON DOESN'T
WANT TO DO IT.
IF THEY DON'T SIGN THE ASSENT
FORM, BUT THE PARENT SIGNS THE
CONSENT FORM, IT WON'T WORK,
THEY STILL CAN'T ENROLL.
OR MAYBE THE PERSON WANTS TO BE
IN, THE PARENT OR LEGAL GUARDIAN
DOESN'T THINK IT'S A GOOD IDEA,
THEY WON'T BE ABLE TO DO IT.
IT TAKES BOTH INDIVIDUALS TO
SIGN THESE FORMS TO AGREE TO BE
IN RESEARCH AND PROVIDES
ADDITIONAL PROTECTIONS.
SO, WE'VE TALKED ABOUT
RANDOMIZATION, THAT'S WHEN
YOU'RE PUT IN ONE OF THESE
GROUPS.
A LOT OF PEOPLE WONDER DO YOU
GET TO PICK YOUR GROUP?
THE ANSWER IS NO.
INDIVIDUALS ARE RANDOMIZED BY
CHANCE AND NOT BY CHOICE.
TYPICALLY A COMPUTER IS THE ONE
ASSIGNING YOU SO YOU CAN'T LIKE
TRY TO CONVINCE SOMEONE TO PUT
YOU IN ONE GROUP OR THE OTHER.
YOUR ODDS OF BEING IN ONE GROUP
VERSUS THE OTHER ARE TYPICALLY
50-50 CHANCE LIKE FLIPPING A
COIN.
SOME ARE DIFFERENT, ENROLLING
MORE IN THE TREATMENT VERSUS
CONTROL ARM.
SOMETIMES YOU HAVE MORE THAN TWO
GROUPS, THAT'S MORE LIKE ROLLING
THE DICE.
DEPENDING ON THE STUDY YOU MIGHT
NOT KNOW WHAT GROUP YOU'RE IN, A
BLINDED TRIAL WHICH WE SEE A LOT
WITH DRUG TRIALS.
DOUBLE BLINDED, THE PEOPLE
CONDUCTING THE STUDY DON'T KNOW
WHAT YOU'RE IN, MORE SEEN IN
DRUG OR SURGICAL TRIALS, IT'S
HARD TO NOT KNOW WHAT GROUP IF
YOU'RE ASKED TO DO SOMETHING.
I TALKED ABOUT PLACEBO OR
CONTROL GROUP.
WHAT IS THAT?
MOST CLINICAL TRIALS WILL
COMPARE A NEW PRODUCT OR THERAPY
WITH ONE THAT ALREADY EXISTS OR
MAYBE ONE THAT DOESN'T EXIST.
SO IN SOME YOU MIGHT BE ASSIGNED
TO CONTROL GROUP THAT MIGHT GET
THE CURRENT TREATMENT OR
WHATEVER WE'RE NORMALLY USING,
STANDARD OF CARE, THE OTHER
GROUP NETS THE NEW TREATMENT.
YOU CAN SEE IS THIS NEW
TREATMENT REALLY BETTER OR EVEN
DEPENDING WHAT THE RESEARCH
QUESTION IS BETTER OR NOT
INFERIOR, GETS SIMILAR RESULTS
AS THE OLD ONCE.
OTHER TIMES YOU MIGHT BE IN THE
DRUG STUDIES WHERE YOU GET A
PLACEBO, AN INACTIVE DRUG.
WE THINK ABOUT LIKE SUGAR PILLS,
IT LOOKS LIKE THE OTHER PILLS,
YOU MAY NOT KNOW ARE YOU GETTING
ONE OR THE OTHER ONE.
IF YOU'RE IN A CONTROL GROUP
SOME MIGHT OFFER YOU THE
TREATMENT GROUP AT THE END BUT
THAT'S NOT ALWAYS THE CASE.
A LOT OF TIMES BEING IN THE
CONTROL GROUP STILL HAS
BENEFITS, IT SHOULDN'T BE
SOMETHING YOU'RE WORRIED OR
SCARED ABOUT.
WILL RESEARCHERS SHARE YOUR DATA
WITH ANYONE?
THE LAW REQUIRES RESEARCHERS
KEEP ALL YOUR IDENTITY AND
ANYTHING THAT COULD IDENTIFY YOU
AS CONFIDENTIAL.
TRADITIONAL AS SOON AS YOU START
A RESEARCH STUDY YOU'LL BE
ASSIGNED A STUDY I.D
ALL THE DATA COLLECTED WILL ONLY
BE ASSOCIATED WITH THAT STUDY
I.D
ONLY A SELECT FEW PEOPLE IN THE
RESEARCH TEAM WILL KNOW WHOSE
NAME IS ASSOCIATED WITH EACH I.D
MAYBE AS SOON AS YOU ENROLL, YOU
STOP BECOMING LAUREN, I START
BECOMING STUDY I.D. 10045, AND
EVERYTHING ABOUT ME IS GOING TO
BE 10045.
YOUR NAME GETS LOST.
NO ONE WILL KNOW YOU'RE IN THE
STUDY OR KNOW PROTECTED
INFORMATION ABOUT YOU.
RESEARCHERS TYPICALLY WILL
PUBLISH THE RESULTS OF THE
STUDY.
HOWEVER A LOT OF TIMES THEY ONLY
DISCUSS GROUP RESULTS, YOUR NAME
WILL NEVER BE USED IN A
PUBLICATION OR PRESENTATION
ABOUT THE CLINICAL TRIAL
UNLESS -- SOME PEOPLE WILL EVERY
NOW AND THEN GIVE ACCESS, IF
IT'S JUST A PICTURE SOMEONE
WANTS TO USE OR VIDEO CLIP BUT
THAT'S A DIFFERENT INFORMATION
THAT'S TAKEN.
TRADITIONALLY NOTHING IS EVER
USED.
SAME THING, THE DATA COLLECTED
MIGHT BE SHARED IN PUBLIC
REPOSITORIES FOR OTHER
RESEARCHERS TO USE FOR RESEARCH,
AGAIN YOUR NAME AND IDENTIFIABLE
INFORMATION WILL NEVER BE
INCLUDED.
WHAT HAPPENS AFTER A CLINICAL
TRIAL IS OVER?
AFTER THE CLINICAL TRIAL IS
COMPLETED, RESEARCHERS WILL LOOK
AT THE INFORMATION COLLECTED AND
MAKE DECISIONS ABOUT THE
MEANINGS OF THE FINDINGS AND
NEXT STEPS OF FUTURE TESTING.
THE RESULTS ARE OFTEN PUBLISHED
IN PEER-REVIEWED JOURNALS, AND A
LOT OF TIMES RESULTS WILL BE
PUBLISHED ON SOMETHING CALLED
clinicaltrials.gov.
ON clinicaltrials.gov, IT'S A
REPOSITORY WHERE ANYTIME BEFORE
YOU START AN INTERVENTION YOU
HAVE TO ENROLL YOUR STUDY AND
PUT IN ALL THE DETAILS ABOUT IT.
THIS WILL BE GOOD FOR HELPING TO
LOOK FOR RESEARCH STUDIES
BECAUSE YOU CAN SEE ANYTHING
CURRENTLY RECRUITING OR IS ABOUT
TO RECRUIT, WHAT CONDITIONS THEY
WORK WITH, WHAT THE INTERVENTION
IS.
AFTER THE TRIAL IS DONE AND
RESEARCHERS ARE REQUIRED TO PUT
RESULTS UP, THIS IS A SCREEN
SHOT OF MIGHT HAVE OWN STUDIES.
YOU CAN SEE ANYONE WHO WANTED TO
BE IN THE STUDY OR IS CURIOUS
ABOUT THE DATA AND DIDN'T WANT
TO LOOK FOR THE PAPER CAN HIT
THE RESULTS TAB AND IT WILL PULL
UP THE RESULTS OF THE STUDY.
IF SOMEONE IS IN THE TRIAL, YOU
MAY OR MAY NOT FIND OUT WHAT
GROUP YOU'RE IN OR WHAT YOUR
INDIVIDUAL RESULTS ARE.
THIS IS DEPENDENT ON THE TRIAL
THAT YOU'RE ENROLLED IN AND WHAT
THEIR RULES ARE.
IF THERE'S EVER ANY REASON IT'S
LIKE CRITICALLY MEDICALLY
NECESSARY TO KNOW WHAT GROUP YOU
WERE IN, THE RESEARCHERS WILL
TYPICALLY RELEASE THAT
INFORMATION.
YOU MIGHT ASK, OKAY, WHAT SHOULD
I BE CONSIDERING BEFORE JOINING
A CLINICAL TRIAL?
THERE'S A BUNCH OF THINGS TO
THINK ABOUT.
WHAT ARE THE RISKS AND WHAT ARE
THE BENEFITS?
HOW CAN IT HELP YOU AND OTHERS?
IS THAT BETTER THAN ANY OF THE
RISKS THE STUDY MIGHT HAVE?
YOU HAVE TO BE OKAY WITH BEING
IN EITHER OF THE STUDY GROUPS.
IF THERE'S ONE YOU'RE WORRIED
ABOUT BEING IN OR DON'T THINK IT
WOULD WORK, IT'S PROBABLY NOT A
STUDY FOR YOU.
YOU HAVE TO LOOK AT TIME
COMMITMENT, IT'S IMPORTANT TO
COLLECT CERTAIN DATA AT CERTAIN
TIMES, IF THEY KNOW YOU'LL HAVE
TO COME IN EVERY SIX MONTHS AND
THESE ARE TIMES, IT WILL TAKE
TWO HOURS, YOU HAVE TO BE
WILLING TO MAKE THAT HAPPEN.
OR IF THEY ASK YOU TO CHANGE OR
DO SOMETHING, YOU HAVE TO AGAIN
LOOK AT YOUR LIFE AND CALENDAR,
IS I FIT THAT IN?
DRIVING TO A HOSPITAL OR
ACADEMIC MEDICAL CENTER EVERY
MONTH, THAT'S REQUIRED, OR EVEN
CHANGING PART OF YOUR LIFESTYLE,
BEING WILLING TO TAKE A NEW
DRUG, THERE'S A LOT OF
CONSIDERATIONS BEFORE JOINING A
TRIAL.
ONE OF THE OTHER CONSIDERATIONS
IS THE ROLE OF THE PARENT OR
CAREGIVER, ESPECIALLY IN DOWN
SYNDROME RESEARCH.
CAREGIVERS ARE OFTEN NEEDED TO
ASSIST WITH TRANSPORTATION
NEEDS, APPOINTMENTS,
INTERVENTION COMPLIANCE, A LOT
OF TIMES COMPLETING
QUESTIONNAIRES OR SURVEYS, OR
TESTING DONE ON THEMSELVES.
OFTENTIMES THE PARENT OR
CAREGIVER IS JUST AS IMPORTANT
TO THE RESEARCH PROCESS AS THE
PARTICIPANT THEMSELVES.
PARENTS AND CAREGIVERS NEED TO
LOOK AT THAT LIST OF WHAT TO
INCLUDE AND DECIDE NOT ONLY DOES
MY LOVED ONE WITH DOWN SYNDROME
HAVE THE ABILITY TO COMMIT TO
THIS BUT ALSO DO I.
SO, WHAT'S BEING DONE TO
INCREASE RESEARCH IN DOWN
SYNDROME?
YOU MAYBE HEARD ME SAY EARLIER
THERE'S NOT A LOT BEING DONE,
NOT A LOT OF RESEARCH INCLUDED
INDIVIDUALS WITH DOWN SYNDROME.
BUT THE NATIONAL INSTITUTES OF
HEALTH HAS A NEW PROJECT CALLED
THE INCLUDE PROJECT,
INVESTIGATION OF CO-OCCURRING
CONDITIONS ACROSS THE LIFESPAN
TO UNDERSTAND DOWN SYNDROME.
THAT WAS MADE TO DEVOTE A LOT OF
TIME AND EFFORT TO FUNDING
CRITICAL RESEARCH IN THE DOWN
SYNDROME POPULATION.
SOME GOALS OF THE INCLUDE
PROJECT ARE CONDUCT CLINICAL
TRIALS THAT INCLUDE INDIVIDUALS
WITH DOWN SYNDROME, AND THEY ARE
DOING TRIALS SPECIFIC TO DOWN
SYNDROME-RELATED RISK SUCH AS
REGRESSION, AND SLEEP APNEA, BUT
ALSO MAKING SURE THAT
INDIVIDUALS WITH DOWN SYNDROME
ARE JUST INCLUDED IN THE GENERAL
RESEARCH STUDY.
THEY ARE WORKING TO BRING NEW
RESEARCHERS INTO THE DOWN
SYNDROME FIELD TO CREATE MORE
STATE-OF-THE-ART MODERN RESEARCH
AND KEEP ALL THE RESEARCH, LIKE
THE CUTTING EDGE, MAKE SURE IT'S
INCLUDING INDIVIDUALS WITH DOWN
SYNDROME.
IN THIS SOUNDS APPEALING, HOW DO
I FIND IF THERE'S RESEARCH
STUDIES THAT MYSELF OR MY LOVED
ONE CAN ENROLL IN, ONE OF THE
BEST PLACES TO GO IS A WEBSITE,
DS-CONNECT, RIGHT HERE, AND IT'S
A DOWN SYNDROME REGISTRY.
FIRST YOU CAN ENROLL AND PROVIDE
BASIC INFORMATION ABOUT THE
PERSON WITH DOWN SYNDROME IN IT.
THAT ACTUALLY IS A RESEARCH
STUDY OF ITS OWN.
IT'S A HEALTH SURVEY, MORE ON
THE OBSERVATIONAL THAT WE TALKED
ABOUT EARLIER BUT ALLOWING
PEOPLE TO COLLECT DATA ABOUT
HEALTH RISKS, DIFFERENT THINGS,
TO HELP EXPAND THE RESEARCH
FIELD.
PARTICIPANTS CAN LEARN ABOUT
CLINICAL TRIALS THROUGH THIS
SITE.
ALMOST ANY OF THESE STUDIES
FUNDED BY THE INCLUDE PROJECT
WILL BE LISTED.
YOU CAN GO TO THIS
clinicaltrials.gov THAT I
TALKED ABOUT EARLIER WITH ANY
CLINICAL TRIAL GOING ON HAS TO
BE REGISTERED THERE.
THERE WILL BE A SEARCH BOX THAT
WILL SAY TYPE IN A MEDICAL
CONDITION YOU'RE INTERESTED IN.
YOU CAN TYPE IN DOWN SYNDROME
OTHER INTELLECTUAL DISABILITY OR
SLEEP APNEA, WHATEVER YOU'RE
MOST PASSIONATE ABOUT.
EVERY STUDY RECRUITING, MAYBE
GETTING READY TO RECRUIT ABOUT
COME UP.
YOU CAN GO THROUGH AND CLICK AND
SEE IF YOU MEET
INCLUSION-EXCLUSION CRITERIA.
IT MAY NOT JUST BE DOWN
SYNDROME-SPECIFIC BUT STILL MAY
QUALIFY.
THE LAST THING, WE WANTED TO
TALK ABOUT SOMEONE INVOLVED IN
CLINICAL RESEARCH AND THEIR
EXPERIENCES.
I WANT TO GO OVER THE STUDY THEY
ARE IN, A LITTLE OVERVIEW.
THIS IS ONE OF MY ONGOING
STUDIES, THE PROMOTION OF
PHYSICAL ACTIVITY FOR PREVENTION
OF ALZHEIMER'S DISEASE IN ADULTS
WITH DOWN SYNDROME.
WE'RE LOOKING TO SEE IF GROUP
REMOTE PHYSICAL ACTIVITY
SESSIONS CAN IMPROVE PHYSICAL
ACTIVITY.
AND LOOKING TO SEE IF PHYSICAL
ACTIVITY HAS ANY EFFECT ON
COGNITION, IMAGING, ANYTHING
RELATED TO ALZHEIMER'S DISEASE.
WHEN SOMEONE IS INTERESTED IN A
STUDY THEY ARE RANDOMIZED, PUT
INTO 1 OF 3 GROUPS, REMOTE HIGH,
THREE GROUP EXERCISES A WEEK.
REMOTE LOW ONE GROUP EXERCISE
SESSION A WEEK, OR ENHANCED
USUAL CONTROL, WHERE THEY DON'T
GET LIVE EXERCISE SESSIONS BUT
MEET WITH A HEALTH COACH TWICE A
MONTH AND THEY GET A FITBIT AND
THEY ARE TOLD TO GET PHYSICAL
ACTIVITY AT HOME.
I'M GOING TO TURN IT BACK OVER
TO ERIKA.
>>THANK YOU SO MUCH, DR.
PTOMEY.
THAT WAS A WONDERFUL
PRESENTATION OVERVIEW.
AGAIN, IF THERE'S QUESTIONS THAT
PARTICIPANTS MAY HAVE, PLEASE
FEEL FREE TO SUBMIT THEM IN THE
CHAT IN Q&A.
WE'LL OPEN UP FOR GENERAL
DISCUSSION.
I'M HAPPY AND PLEASED TO
INTRODUCE OUR STUDY PARTICIPANTS
THAT DR. PTOMEY MENTIONED.
FIRST WE HAVE SEAN ROBERT
KORTAN, 22 YEARS OLD, A YOUNG
ADULT WITH DOWN SYNDROME.
HE PARTICIPATES IN DR. PTOMEY'S
STUDY.
HE IS THE MIDDLE OF THREE SONS,
VERY ACTIVE.
HE'S PLAYED CHALLENGER BASEBALL,
SOCCER, SWAM FOR SPECIAL
OLYMPICS, RAN TRACK,
PARTICIPATED IN WEIGHT LIFTING,
PARTICIPATED IN UNIFIED BOWLING
AND LEARNED TO RIDE A BICYCLE.
WHEN WE SAY SEAN IS VERY ACTIVE,
SEAN IS VERY ACTIVE.
AFTER GRADUATING FROM THE
ELKHORN YOUNG PROGRAM IN MAY OF
2022 SEAN LANDED A JOB AT COFFEE
SHOP ATTENDANT, INCLUDING
STOCKING THE SHOP AS WELL AS
CLEANING THE SHOP AND
SURROUNDING AREAS.
HE TAKES GREAT PRIDE IN HIS
WORK, STRIVES TO PLEASE HIS
MANAGER, HIS JOB FULFILLS SEAN'S
DESIRE TO BE AROUND AND BUILD
RELATIONSHIPS WITH OTHERS.
OUTSIDE OF WORKS HE LOVES TO
SING, DANCE, PLAY DRUMS, SWIM,
AND HANG OUT WITH HIS FAMILY.
WE'RE ALSO PLEASED TO HAVE WITH
SEAN HIS MOTHER, LISA KORTAN.
LISA GREW UP IN A SMALL TOWN IN
SOUTH DAKOTA, THE OLDEST OF FOUR
CHILDREN.
AFTER HIGH SCHOOL SHE ATTENDED
COLLEGE IN YANKTON, SOUTH
DAKOTA, A DEGREE IN SECONDARY
EDUCATION.
WHEN THE FIRST CHILD WAS BORN
LISA WOULD STAY HOME AND BE A
FULL-TIME MOM.
SEAN WAS BORN TWO YEARS LATER,
CARSON WAS BORN SEVEN YEARS
AFTER THAT.
LISA IS SEAN FRONT'S LINE
CAREGIVER, ADVOCATE, TEACHER,
COACH, FRIEND AND HER MOST LOVED
ROLE IS HIS MOTHER.
WE'LL START OFF BY ASKING A FEW
QUESTIONS OF LISA AND SEAN.
FIRST WE WANT TO SAY WELCOME AND
THANK YOU AGAIN FOR BEING HERE.
SO, LISA, COULD YOU TELL US HOW
YOU LEARNED ABOUT DR. PTOMEY'S
STUDY AND WHY YOU DECIDED TO
PARTICIPATE IN THE STUDY?
>>SURE.
HI, EVERYBODY.
WELL, WE WERE DRIVING HOME FROM
KANSAS CITY.
WE LIVE IN OMAHA.
I WAS COLLECTING MY E-MAILS.
I RECEIVED AN E-MAIL FROM A
FRIEND HERE IN OMAHA, WHO I
BELIEVE HER SON ACTUALLY WAS IN
THE STUDY THE YEAR BEFORE SEAN.
AND SO I READ ABOUT THE STUDY,
AND THEY NEEDED I THINK MAYBE
SIX MORE PEOPLE TO JOIN THE
STUDY.
IT WAS A LAST-MINUTE PLEA FOR
CAN ANYBODY ELSE JOIN, WE'RE
TRYING TO GET THIS DONE, SO I
READ ABOUT IT.
AND JUST SEEMED LIKE A WIN-WIN
SITUATION.
YOU KNOW, IT WAS GOING TO BE
RESEARCH THAT COULD BENEFIT SEAN
POSSIBLY LATER IN HIS LIFE, AND
HE WAS GOING TO GET HEALTHIER
THROUGHOUT THE PROCESS.
SO I THOUGHT WHY NOT?
SO WE TOOK A CHANCE AND SIGNED
UP.
AND HERE WE ARE.
>>AWESOME.
WELL, AS WE LEARNED FROM DR.
PTOMEY'S PRESENTATION, ASSENT IS
PART OF IT.
SO, SEAN, YOU CLEARLY ASSENTED
TO PARTICIPATE IN THE STUDY.
CAN YOU TELL US WHAT IS IT THAT
YOU LIKE ABOUT PARTICIPATING IN
THE STUDY SO FAR?
>>I AM VERY STRONGER, AND
HAPPY, MORE ABS.
I WANT TO PLAY WITH MY BROTHERS
AND MOTHER AND FATHERS, UNCLES,
COUSINS.
>> I KNOW YOU WERE READING WHAT
YOU WROTE DOWN BUT SHE'S ASKING
WHAT DO YOU LIKE ABOUT BEING
IN -- DOING THE EXERCISE STUDY
WITH TRAINER JESSI, WHAT DO YOU
LIKE ABOUT IT?
WHAT DOES IT DO FOR YOU?
>>I'M VERY, VERY SMART.
>>IT MAKES YOU SMART.
AND?
>>AND STRONGER.
>>IT MAKES YOU STRONGER, YES.
>>THAT'S AWESOME.
YOU MENTIONED FAMILIES MEMBERS
YOU'RE PARTICIPATING WITH.
DO YOU HAVE A HEALTHY
COMPETITION WITH YOUR SIBLINGS,
WITH YOUR BROTHERS, WHO CAN DO
MORE PUSH-UPS?
I'M JUST CURIOUS.
>>DO DO YOU ANY EXERCISES WITH
YOUR BROTHERS?
>>I PLAY -- ARM WRESTLING WITH
THEM.
>>ARM WRESTLING WITH THEM.
IS THERE ANYTHING YOU DO IN THE
BASEMENT WITH YOUR BROTHERS FOR
EXERCISE?
>>THEY ARE ALSO PLAY DRUMS
WITH PLEA.
>>DRUMS.
AND ALSO --
>> ALSO DANCE TOO.
>>THEY DO A LOT OF DANCING
WITH THE NINTENDO SWITCH.
>>IT'S A GREAT FORM OF
EXERCISE, ONE I THINK THAT'S
UNDERAPPRECIATED.
A QUESTION FOR YOU, LISA, AS THE
STUDY IS ONGOING, HAVE THERE
WILL BE BENEFITS YOU'VE NOTICED
ABOUT PARTICIPATING IN THE
STUDY?
FOR SEAN AND FOR YOU AS WELL.
>>SURE.
I THINK -- WELL, WEARING THE
FITBIT, YOU KNOW, THE STEPS SHOW
UP RIGHT AWAY.
AND YOU GUYS JUST TALKING WITH
US, YOU HEARD ABOUT SEAN'S CRAZY
STEP NUMBERS THAT HE'S GETTING.
I THINK ONE OF THE BENEFITS IS
JUST THE AWARENESS OF THE
EXERCISE OR AMOUNT OF EXERCISE
HE'S GETTING.
IT'S A CONSTANT HIM TELLING US
AND LETTING US KNOW THE EXERCISE
THAT HE'S GETTING.
I THINK, YOU KNOW, THERE'S
BEEN -- I MEAN THERE'S A LOT OF
THINGS.
YOU KNOW, WE CALL HIM TRAINER,
OR BOY JESSI, BECAUSE WE HAVE
OTHER JESSIES IN THE REALM OF
THE STUDY.
JUST TALKING WITH JESSI, WE'VE
GOTTEN SOME PROTEIN POWDER, YOU
KNOW, THAT SEAN IS DOING EACH
DAY, WHICH HAS LED TO OUR ADULT
SON THAT DOESN'T LIVE WITH US
DOING THE SAME PROTEIN POWDER.
MY HUSBAND DOING THE PROTEIN
POWDER.
THAT'S SOMETHING ADDED TO OUR
LIFE, WHICH IS A BENEFIT.
AND, YOU KNOW, DOING -- WE'RE
CONSTANTLY TALKING ABOUT
EXERCISE BECAUSE OF THE STEPS
SEAN IS DOING.
THAT'S BENEFICIAL.
SO JUST SIMPLE EVERYDAY THINGS
THAT ARE MAKING US HEALTHIER
AND, YOU KNOW, BETTER
FUNCTIONING PEOPLE.
SO I THINK THOSE ARE POSITIVE
THINGS.
>>ABSOLUTELY.
AND IF YOU DON'T MIND, I'D LOVE
TO SHARE WITH THE GROUP HOW MANY
STEPS SEAN HAS GOTTEN OVER THE
PAST WEEKEND.
>>YEAH.
HOW MANY STEPS YESTERDAY?
>>TWENTY-FOUR.
>>A CRAZY WEEKEND.
THE NIGHT BEFORE 21,000.
>>23,000.
>>THERE YOU GO.
IT'S IMPORTANT TO GET IT
CORRECT.
THAT IS AMAZING TO HAVE THAT
MANY STEPS.
IT'S GREAT TO SEE THE STUDY
HELPS TO ENCOURAGE THAT AS WELL.
WE'RE TALKING A LOT ABOUT THE
POSITIVE AND IT'S GOOD TO SEE A
BALANCED VIEW.
SO, HAVE THERE BEEN CHALLENGES,
LISA AND SEAN, THAT YOU SEE WITH
PARTICIPATING IN THE STUDY?
>>WE'LL GET SEAN GO FIRST.
IS THERE ANYTHING YOU DON'T LIKE
ABOUT DOING THE EXERCISE STUDY?
ANYTHING THAT'S HARD OR THAT YOU
DON'T LIKE?
>>THE SQUATS HURT MY LEGS AND
KNEES.
>>OH, THE SQUATS ARE HARD
SOMETIMES.
THERE'S THAT.
I WOULD SAY FOR ME, REALLY IT
HASN'T BEEN CHALLENGING.
I WOULD SAY IN THE BEGINNING, I
MEAN, AS YOU GUYS KNOW NOW THAT
YOU MET ME I'M NOT VERY
TECHNICAL.
SO THE WHOLE WEBINAR HAS BEEN
THE BIGGEST CHALLENGE.
IN THE BEGINNING WITH THE FITBIT
IT WAS GETTING IT CONNECTED, IT
WASN'T SYNCING RIGHT.
SO IT WAS OH MY GOSH, LIKE CAN
WE DO THIS?
COMPLICATED FOR ME.
AND SO I'LL HAVE TO SAY ANYTIME
WE'VE HAD DIFFICULTIES, I CAN
CALL SOMEBODY, E-MAIL SOMEBODY,
TEXT SOMEBODY, AND EVERYBODY HAS
BEEN VERY HELPFUL.
EVEN THOUGH CHALLENGING, THERE
WAS SUPPORT.
I'M A STRAIGHT SHOOTER.
IF I SAY I'M GOING TO DO
SOMETHING, I'LL DO IT.
WITH SOMEBODY SAYING, YEAH,
WE'LL HELP YOU, OBVIOUSLY THEY
HELPED ME AND THAT WAS A SIMPLE
THING.
I APPRECIATED THAT.
SO THE OTHER PART, WE ARE -- WE
ALREADY HAVE MENTIONED BOY
JESSI, OUR TRAINER.
WE HAVE HIM EVERY OTHER WEEK.
WE MEET WITH HIM THROUGH ZOOM.
SO WHICH OBVIOUSLY WE'RE CAPABLE
OF DOING.
SO THAT MAYBE WOULD HAVE BEEN
CHALLENGING FOR SOME PEOPLE.
DOING THE REMOTE, YOU KNOW, THAT
WE'RE IN OMAHA, THEY ARE IN
KANSAS CITY.
BUT THAT KIND OF WORKED OUT AS A
BENEFIT FOR US, NOT A CHALLENGE,
BECAUSE I MEAN EVERYBODY IS
BUSY.
FOR US, THAT FIT IN OUR SCHEDULE
BETTER.
MORE RURAL FOLLOWERS.
SO SEAN WOULD GET -- GO THROUGH
THE EXERCISING WITH JESSI AND
COULD SHOW HIM IF THERE WAS
SOMETHING NEW HE DIDN'T KNOW HOW
TO DO, WE WOULD WRITE DOWN YOUR
GOAL FOR THIS WEEK IS 12,000
STEPS OR 13,000 STEPS, WHATEVER
IT WAS.
AND THEN LET'S DO PUSH-UPS OR
SQUATS THIS WEEK OR WHATEVER IT
WOULD BE, WE WOULD WRITE IT
DOWN.
I'M LUCKY THAT SEAN IS CAPABLE
AND SEAN WOULD STICK TO THE
ROUTINE AND HE WOULD ADD THOSE
IN.
SO, I GUESS THAT'S NOT REALLY A
CHALLENGE BUT IT COULD HAVE
BEEN.
BUT IT HASN'T BEEN.
I FEEL LIKE I'VE BEEN VERY
SUPPORTED.
>>THAT'S IMPORTANT.
THERE'S NO CHALLENGES, YOU KNOW,
THAT'S A GREAT THING.
IT'S GREAT THAT THE RESEARCH
PROGRAM LAST THE INFRASTRUCTURE
IN PLACE TO BE ABLE TO REACH
POPULATIONS THAT ARE OUTSIDE OF
THE CATCHMENT AREA AND IN MORE
GEOGRAPHICALLY RURAL
POPULATIONS.
SO, ONE LAST QUESTION FOR THE
TWO OF YOU.
IS THERE ANYTHING THAT YOU WOULD
LIKE THE RESEARCHERS TO KNOW OR
CONSIDER WHEN THEY ARE PLANNING
ANY FUTURE STUDIES OR CLINICAL
TRIALS?
OKAY..
>>LIKE WHEN THIS IS DONE IF WE
WERE GOING TO DO ANOTHER STUDY,
IF WE WERE DOING TO DO THIS
AGAIN, WHAT WOULD YOU WANT TO
TELL THEM?
WHAT WOULD YOU LIKE ABOUT IT OR
WANT IT TO BE?
>>I WANT IT TO BE FUN AND BE
MORE HEALTHY.
>>BE MORE HEALTHY AGAIN AND
FUN.
>>YEAH.
AND GET STRONG.
>>SOMETHING TO MAKE YOU
STRONG.
>>UH-HUH.
AND THEN TO DO IT WITH FAMILY
AND FRIENDS.
>>THAT'S GOOD.
YEP, I AGREE WITH THAT.
I THINK -- WELL, I THINK DR.
LAUREN HIT ON IT.
I DIDN'T KNOW WHAT THE SLIDES
WERE GOING TO BE.
I WOULD HAVE PROBABLY BROUGHT
UP, YOU KNOW, IT'S NOT JUST
ABOUT SEAN BEING IN THE STUDY.
OBVIOUSLY, YOU CAN SEE HOW WE
COMMUNICATE.
THAT'S HOW JESSI DEALS WITH US.
SOMETIMES SEAN DOESN'T
UNDERSTAND THE QUESTION, I BREAK
IT DOWN.
WE'RE A TEAM.
THAT'S HOW SEAN, YOU KNOW, GETS
THROUGH LIFE IS ME.
SO, WE -- THE STUDY HAS TO WORK
FOR BOTH OF US.
AND I THINK ONE SLIDE SAID THAT.
IT'S NOT JUST HIM COMMITTING TO
THE STUDY.
IT'S BOTH OF US.
I THINK AS LONG AS THE STUDY IS,
YOU KNOW, POSITIVE, AND, YOU
KNOW, JUST LIKE THIS ONE, WHEN I
READ IT, IT MADE SENSE TO ME.
YOU KNOW, SO I GUESS I'M
ASSUMING MOST CLINICAL TRIALS IN
RESEARCH ARE SUPPOSED TO WORK
OUT THAT WAY.
SO I THINK I TOLD YOU GUYS
BEFORE, I FEEL GUILTY THAT MAYBE
I HAVEN'T BEEN IN ONE BEFORE.
WE HAVEN'T BEEN IN ONE BEFORE.
BUT WE'RE JUST AT A TIME IN OUR
LIFE THAT THIS IS WORKING FOR
US.
SEAN IS OUT OF SCHOOL, HAS HIS
FIRST JOB, WE'RE MORE OPEN TO
BEING ABLE TO PARTICIPATE MORE.
SO, I FEEL LIKE AS LONG AS
STUDIES ARE, YOU KNOW, THE
COMMITMENT IS THERE TO WORK WITH
US, WHICH OBVIOUSLY LIKE I SAID
WE FEEL SUPPORTED IN THIS STUDY,
SO WE'RE HAVING A GOOD
EXPERIENCE, I FEEL LIKE AS LONG
AS PEOPLE GET THAT, AND HAVE
THAT FEELING, YOU'RE GOING TO BE
ABLE TO FIND PEOPLE TO BE IN
TRIALS AND RESEARCH AND STUDIES.
SO, AGAIN, THAT WIN-WIN
COMBINATION.
>>ABSOLUTELY.
I THINK THAT RAISES A GREAT
POINT.
I'LL ACTUALLY OPEN AND WELCOME
DR. PTOMEY AS WELL TO THE
DISCUSSION BECAUSE I THINK THIS
TOUCHES ON SOMETHING THAT
PERTAINS TO BOTH OF YOU.
LOOKING -- THE POINT YOU RAISED
ABOUT PARTICIPATING IN CLINICAL
TRIALS AND CLINICAL STUDIES NOW
BECAUSE SEAN IS AT A POINT WHERE
HE'S OUT OF SCHOOL AND HAS A
LITTLE BIT MORE FREEDOM, DO YOU
FEEL THAT THE COMMITMENT FOR
TIME PARTICIPATE IN STUDIES, AIR
QUOTES HERE, MAY HAVE BEEN A
DETERRENT OR REASON AS TO WHY
YOU MAY NOT HAVE PARTICIPATED
EARLIER?
>>OH MY GOSH.
>>I'M SORRY IF I OPENED A CAN
OF WORMS.
>>I KNOW, THAT'S A LOT!
I DON'T KNOW IF THERE REALLY WAS
A TRIAL THAT WAS PRESENTED TO ME
BEFORE, AND MAYBE THAT'S BECAUSE
OF HIM HAVING DOWN SYNDROME.
WERE THEY OUT THERE?
>>THERE'S BEEN A LOT MORE
TRIALS COMING OUT RECENTLY,
ESPECIALLY WITH THE NATIONAL
INSTITUTES OF HEALTH INCLUDE
INITIATIVE.
I THINK YOU GUYS ARE ALSO IN A
UNIQUE POSITION THAT, YOU KNOW,
YOU LIVE IN AN AREA WITHOUT HUGE
ACADEMIC MEDICAL CENTER
CONDUCTING THESE TRIALS.
FOR THIS ONE SINCE WE DECIDED IT
WAS REMOTE AND WE COULD REACH
OUT TO SURROUNDING AREAS WE WERE
ABLE TO ENROLL AND FIND OUT MORE
ABOUT THAT BUT I'M HOPING, YOU
KNOW, IN THE FUTURE YOU'LL HAVE
MORE ACCESS TO THESE TRIALS, OR
KNOW ABOUT THEM.
I THINK THAT'S ONE NICE THING
THAT THE D S CONNECT SITE,
THERE'S SOME OUT THERE,
REMOTELY, YOU CAN JOIN THE
REGISTRY, BUT RESEARCHERS CAN
USE IT TO ANSWER REALLY BIG
QUESTIONS.
SO, YEAH, THERE PROBABLY WEREN'T
A TON OF STUDIES OUT THERE
ESPECIALLY WHERE YOU ALL LIVE
BUT HOPEFULLY THAT'S CHANGING
NOW.
AND YOU'LL STILL, LIKE I SAID,
WE'RE GOING TO KEEP BUGGING YOU
NOW.
>>RIGHT, YES, I REMEMBER THAT.
I THINK JUST LIKE THE OTHER DAY
WHEN WE WERE TALKING ABOUT HOW
MY FRIEND -- WE LIVED HERE 20
YEARS, I HAVE A BEST FRIEND FROM
ALL 20 YEARS, HER SON ALSO HAS
DOWN SYNDROME, SAME AGE AS SEAN.
WHEN WE MOVED HERE IT WAS KIND
OF LIKE EVERYBODY HAD THE SAME
PEDIATRICIAN, THE SAME EYE
DOCTORS.
AND NOW THAT OUR SON AND OUR
FRIEND GROUPS THAT GROWN UP AND
CHILDREN ARE OLDER WE BRANCHED
OUT BECAUSE EVERYBODY CAN TAKE
THEIR SON OR DAUGHTER AND JUST
GO TO THEIR SAME GENERAL DOCTOR.
YOU KNOW, HE CAN COME TO MY SAME
DOCTOR.
WE DON'T HAVE A SPECIALIZED
PEDIATRICIAN OR SPECIALIZED EYE
DOCTOR ANYMORE THAT WE ALL SEEM
TO GO TO WHEN OUR CHILDREN WERE
LITTLE.
I FEEL LIKE A LITTLE BIT MORE
BRANCHED OUT AND MAYBE -- YOU
KNOW, MAYBE WE'RE JUST A LITTLE
MORE DISPERSED, OUR INFORMATION,
I DON'T KNOW, I THINK THAT'S
WHAT I WAS TRYING TO GET ACROSS
THE OTHER DAY.
I FEEL LIKE WE'RE A LITTLE BIT
MORE SPREAD OUT WHICH SEEMS
CONFUSING BECAUSE NOW WITH ALL
THE SOCIAL MEDIA WE SHOULD BE
MORE CONNECTED.
BUT SEEMS LIKE WE'RE NOT, FOR
SOME REASON.
SO I DON'T KNOW WHAT THAT IS.
BUT I GUESS WITH THIS RESEARCH
AND -- I DON'T KNOW.
MAYBE.
MAYBE WE CAN GET SOMETHING GOING
AND MAYBE NOW THAT LIKE I'M NEW
TO THE TRANSITION, MAYBE THERE'S
SOMETHING OUT HERE I DON'T KNOW
ABOUT YET AND JUST LIKE THIS, I
DIDN'T KNOW ABOUT CLINICAL
TRIALS AND NOW I'M IN.
>>YOU'RE DEFINITELY IN NOW.
>>YEAH, I'M IN.
AND WE'VE LIVED OUR LIFE THAT
WAY.
I KNEW WERE THINGS COMING DOWN
THE ROAD BUT ONLY SO MUCH I
COULD KNOW, FOR ALL MY KIDS BUT
MAINLY SEAN, ONLY SO MUCH I
COULD KNOW.
I WOULD LEARN AS HE GOT OLDER.
I GUESS THAT'S PART OF THIS.
THAT'S WHERE WE'RE AT.
>>I THINK YOU TOUCHED ON AN
IMPORTANT POINT THERE, AND
THAT'S HOW WE HANDLE
COMMUNICATION.
IN TERMS OF DISSEMINATION TO
DIFFERENT AGE POPULATIONS, LIKE
YOU SAID BEFORE, WHEN YOU WERE
YOUNGER, PEDIATRICIAN WAS
SPECIALIZED IN PROVIDING CARE.
BUT NOW THAT SEAN'S OLDER AND
IT'S PERHAPS A BIT MORE SPREAD
OUT IN TERMS OF ACCESSING THE
INFORMATION, SO PERHAPS WE
CAN -- IMPROVING IMPROVING TYPF
COMMUNICATION AND DISSEMINATION
THAT REACH ALL POPULATIONS MAY
BE BENEFICIAL.
AS DR. PTOMEY MENTIONED,
DS-CONNECT IS A GREAT STARTING
POINT AND WE CAN MAKE AVAILABLE
TO YOU, AND CAN YOU SHARE WITH
YOUR FRIENDS, SOME RESOURCES
THAT WILL BE AVAILABLE.
>>ERIKA, I HAVE A QUESTION FOR
LAUREN.
THIS TOUCHES ON IT.
REMOTE EVALUATION, HAVING PEOPLE
NOT HAVE TO COME INTO YOUR
CLINIC, THAT'S BEEN A GAME
CHANGER.
CAN YOU TALK ABOUT HOW THAT'S
REALLY ALLOWED YOU TO GET
RESEARCH TO MORE INDIVIDUALS BY
BEING ABLE TO HAVE THESE REMOTE
SESSIONS, USING ZOOM, THINGS
LIKE THAT?
>>YEAH.
I JOKE, WE USED REMOTE BEFORE
REMOTE WAS COOL.
WE STARTED A LONG TIME AGO.
WORKING IN THE DOWN SYNDROME
WORLD WE REALIZED TRANSPORTATION
IS AN ISSUE, IN PHYSICAL
ACTIVITY HAVING TRAINERS
SPECIALIZE IN WORKING WITH GAIT
INSTABILITY OR LOW MUSCLE TONE.
THEY DIDN'T KNOW WHAT THEY WERE
DOING.
YOU HAVE THE SOCIAL STIGMA AND
SOCIAL SUPPORT.
WHEN WE STARTED DOING THESE
GROUP REMOTE EXERCISE SESSIONS,
IT ALLOWED MORE PEOPLE TO --
TOOK AWAY BARRIERS, ALLOWED
SOCIAL SUPPORT.
THE STUDY WE TALKED ABOUT
STARTED UP ABOUT -- IN JANUARY,
2020.
AND SO, YOU KNOW, BEFORE COVID
BUT AS SOON AS THAT HIT WE WERE
ABLE TO CONTINUE GOING JUST AS
PLANNED.
EVERYONE REALLY APPRECIATED IT
THEN BECAUSE THEY GOT THE SOCIAL
SUPPORT THEY WERE LACKING.
ONE OTHER THING, WE HAD EVERYONE
COMING INTO OUR LAB EVERY SIX
MONTHS FOR THESE TESTS.
AND, YOU KNOW, WE HAD TO MODIFY
OR PIVOT BECAUSE NOT EVERYONE
COULD COME IN, CONCERNS ABOUT
SOMEONE WHO DOESN'T WANT AN MRI
AND WORRYING ABOUT COVID?
SO WE WERE ABLE TO FIGURE OUT,
OKAY, OUR MAIN OUTCOMES, THAT WE
CARE ABOUT THE MOST, WE DON'T
HAVE TO HAVE SOMEONE IN THE LAB
FOR.
WE COULD OFFER KIND OF REMOTE
TESTING AS WELL.
AND IT REALLY DID, IT ALLOWED
SOMEONE LIKE SEAN WHO LIVES 2
1/2 HOURS AWAY FROM US TO BE
ABLE TO JOIN THE STUDY.
WE'VE HAD PEOPLE FROM WESTERN
KANSAS, FROM SOUTHERN MISSOURI
AND ARKANSAS JOIN THE STUDY.
AND BE ABLE TO GET THIS
INTERVENTION, IMPORTANT AS WE
CONTINUE TO DO RESEARCH.
HOW DO WE ACCESS EVERYONE?
HOW DO WE MAKE SURE EVERYONE HAS
THE SAME AVAILABILITY TO JOIN
THESE REALLY NICE RESEARCH
STUDIES AND GET THE MOST
STATE-OF-THE-ART TREATMENT AND
BE INCLUDED.
>>I THINK THAT'S A GREAT POINT
BECAUSE -- WITH THAT REACH I'M
SURE YOU'RE ABLE TO REACH A MORE
DIVERSE STUDY POPULATION AS
WELL.
THAT'S HISTORICALLY BEEN
UNDERREPRESENTED, GEOGRAPHICALLY
OR OTHERWISE.
I HAVE A QUESTION.
I'LL PIGGYBACK OFF LAURIE'S
QUESTION TO DR. PTOMEY.
THE SAME QUESTION I PRESENTED
WITH LISA AND SEAN, IF THERE'S
ANY FEEDBACK THAT YOU COULD
PROVIDE TO RESEARCHERS ABOUT
CLINICAL TRIALS, WHAT WOULD YOU
LIKE THEM TO KNOW?
>>YOU KNOW, I THINK THE
BIGGEST THING WHEN DOING A
CLINICAL TRIAL, ESPECIALLY FOR
INDIVIDUALS WITH DOWN SYNDROME,
MAKING SURE IT'S A CLINICAL
TRIAL FOR INDIVIDUALS WITH DOWN
SYNDROME.
YOU HAVE TO LOOK AT THAT PERSON,
WHAT ARE THEIR UNIQUE NEEDS,
WHAT WILL THEY ENJOY, WHAT MAKES
SOMETHING WORTHWHILE TO DO?
THAT'S ONE THING WE SPENT A LONG
TIME DOING, FIGURING OUT WHAT'S
GOING TO BE THE BEST FOR THIS
PERSON.
AND MAKE SURE IT'S SAFE FOR THIS
PERSON.
AND I THINK THAT HELPS A LOT OF
COMING UP WITH SUCCESSFUL
INTERVENTION.
REALLY ALSO LOOKING AT WHAT DO
WE NEED OF THE CAREGIVER, MAKING
SURE THAT'S CLEAR, YOU HAVE TO
CONSIDER THEM BOTH, AS LISA
WOULD SAY, IT'S NORMALLY A TEAM.
AND KINDS OF KNOWING, SETTING
OUT EXPECTATIONS AHEAD OF TIME.
THE BIGGEST THING FOR RESEARCHES
AND OTHER PEOPLE, IN TERMS OF
RECRUITMENT, HOW YOU GET IN, ONE
THING WE'VE BEEN COGNIZANT ABOUT
IS MAKING COMMUNITY
PARTNERSHIPS.
WORKING AS A TEAM, WHAT CAN WE
GIVE BACK TO THE COMMUNITY AND
BE DOING, OUR PART?
THAT MAKES A DIFFERENCE TOO.
WE HAVE A GREAT GROUP HERE, DOWN
SYNDROME INNOVATION IN KANSAS
CITY, SERVING INDIVIDUALS WITH
DOWN SYNDROME.
THEY ARE WONDERFUL.
WE'VE BEEN PARTNERING TO PROVIDE
THEM SERVICES AND THEY HAVE BEEN
HELPING IN RESEARCH STUDIES.
I THINK SOME OF THOSE KEY
PARTNERSHIPS ARE -- YOU HAVE TO
HAVE.
AND YOU ALWAYS HAVE TO REMEMBER,
IT'S NOT JUST WHAT CAN I GET BUT
WHAT CAN I GIVE.
>>I THINK THAT'S AN EXCELLENT
POINT.
SOMETHING I THINK CAN OFTENTIMES
BE FORGOTTEN.
>>I AGREE COMPLETELY.
I'M LOOKING AT OUR TIME TO MAKE
SURE THAT MAYBE WE'D LIKE TO
GIVE LISA AND SEAN THE LAST
WORDS, WHAT YOU WOULD LIKE TO
LET FOLKS KNOW?
>>ANYTHING YOU WANT TO SAY?
>>MORE FAMILY.
>>HE LOVES LIST FAMILY.
>>A SHOUT OUT, SEAN.
>>AND HIS MOM?
>>AND BEST FRIEND.
>>HIS BEST FRIEND ALMOST GOT
IN THE STUDY BUT THEY GOT TOO
BUSY.
BUT I THINK LIKE DR. LAUREN WAS
SAYING, THE REMOTE I THINK IS
AWESOME.
I MEAN, I THINK YOU GUYS COULD
REALLY -- I MEAN, THINK THAT'S
KEY.
IT WORKED WELL FOR US.
I APPRECIATE IT.
I KEEP SAYING I APPRECIATE SO
MUCH THE SUPPORT.
EVEN THEY HAVE PEOPLE COMING
HERE TO DO LIKE SEAN'S THREE
MONTH AND SIX MONTHS CHECK-INS.
WE DON'T EVEN HAVE TO DRIVE TO
KANSAS CITY WHICH IN THE
BEGINNING I THOUGHT WE WERE
GOING TO BE DOING.
EVEN THAT HAS BEEN EVEN MORE
HELPFUL TO US.
SO I CAN'T SAY ENOUGH HOW GREAT
THIS FIRST STUDY FOR US HAS
BEEN.
SO, IF ANYBODY IS QUESTIONING
LIKE IF THIS IS WHAT YOU'RE
WANTING TO DECIDE, TO DECIDE IF
YOU'RE GOING TO PARTICIPATE IN
ONE, GIVE IT A TRY.
THAT'S WHAT I WOULD SAY.
AND I DIDN'T EVEN KNOW YOU COULD
GET OUT ONCE YOU GOT IN.
SO WHY WOULDN'T YOU TRY?
SO THERE YOU GO.
>>ERIKA, WE HAVE ONE QUESTION
IN THE CHAT THAT MAYBE TYPED AN
ANSWER TO, A DR. PTOMEY, WHAT
ADVICE WOULD YOU GIVE TO
FAMILIES CONSIDERING
PARTICIPATING IN CLINICAL TRIALS
WITH THEIR LOVED ONES WITH DOWN
SYNDROME, ESPECIALLY FAMILIES
WHO DO NOT SPEAK ENGLISH?
>>I WAS TYPING AN ANSWER FOR
THIS BUT HAPPY TO DO IT OUT LOUD
INSTEAD.
I THINK WHAT YOU WERE SAYING,
I'M GOING TO GET TO THE HEART OF
THE MATTER OF FAMILIES WHO DON'T
SPEAK ENGLISH.
THERE'S A COUPLE THINGS WENT OUT
TO A LOT OF GROUPS, THEY WILL
HAVE TRANSLATORS TO TRANSLATE
MATERIALS OR ALREADY HAVE
MATERIALS IN SPANISH.
IN AGING A LOT HAVE BEEN ADAPT
AND ARE AVAILABLE, WHICH HELPS.
OUR GROUP, MOST OF THEM DON'T
SPEAK SPANISH.
SO WHEN WE'VE HAD INDIVIDUALS
WHO ARE ONLY SPANISH SPEAKING,
THE CAREGIVER OR LOVED ONE IS,
DO YOU HAVE A FRIEND THAT CAN
HELP TRANSLATE OR ANOTHER FAMILY
MEMBERS?
MOST OF THE TIME WE'VE BEEN ABLE
TO FIND SOMEONE.
WE INCLUDE THEM, JUST HAVE HAVE
A WAY TO BRIDGE THE LANGUAGE
BARRIER.
BUT MOST PEOPLE ARE TRYING TO DO
THAT AND MAKE IT FEASIBLE
BECAUSE WE WANT TO INCLUDE
EVERYBODY.
BUT I WOULD SAY TOO, DON'T BE
AFRAID OF REACHING OUT, DON'T BE
AFRAID TO FIND OUT WHAT SERVICES
WOULD BE AVAILABLE IF YOU JOIN
THE STUDY.
WOULD THEY TRANSLATE MATERIALS?
WOULD THEY HAVE SOMEONE FAMILIAR
WITH YOUR CULTURE?
YOU KNOW, AND WHAT CAN BE DONE?
BECAUSE A LOT OF TIMES
ACCOMMODATIONS CAN BE MADE.
SO DON'T BE AFRAID TO REACH OUT,
ASK QUESTIONS, AND SEE WHAT YOU
CAN DO.
>>I THINK THAT'S AN EXCELLENT
POINT AND THANK YOU, DR. PTOMEY.
WE WANT TO THANK ALL OF OUR
PARTICIPANTS FOR JOINING.
LISA, SEAN, THANK YOU SO VERY
MUCH.
WE APPRECIATE IT.
LAUREN, THANK YOU FOR YOUR TIME.
AND ON BEHALF OF THE INCLUDE
PROJECT HERE AT NIH I'LL TURN IT
OVER TO DR. LAURIE RYAN TO SAY
LAST WORDS BUT THANK YOU FOR
YOUR PARTICIPATION IN TODAY'S
WEBINAR.
>>I WILL ECHO EVERYBODY
ERIC -- EVERYTHING ERIKA SAID.
SEAN, LISA, THANK YOU.
LAUREN, YOU DID BREAK DOWN WHAT
IT'S LIKE TO PARTICIPATE IN
CLINICAL TRIALS, A GREAT
OVERVIEW.
WE CAN'T THANK YOU ENOUGH.
THIS WILL BE AVAILABLE ON VIDEO
ARCHIVE TO LOOK AT.
THANK YOU FOR YOUR TIME.
THIS HAS BEEN A WONDERFUL
WEBINAR.
>>HAVE A GREAT DAY, EVERYONE.
>>THANK YOU.
>>BYE.