Trial Outcomes & Findings for Developing a Down Syndrome Health Instrument (NCT NCT04631237)
NCT ID: NCT04631237
Last Updated: 2026-04-27
Results Overview
Local and national survey results, cognitive interviews and validation of Down syndrome health measure (DSHM) using psychometric analysis and factor analysis
Recruitment status
COMPLETED
Target enrollment
758 participants
Primary outcome timeframe
At the time of survey completion
Results posted on
2026-04-27
Participant Flow
Some individuals who started the survey did not elect to complete it / reach the end of the survey. Only participants who had made it through the whole survey / to the end were included in analysis.
Participant milestones
| Measure |
Focus Groups
N=28
Observational, no intervention: No intervention involved
|
Cognitive Interviews
N=42
Observational, no intervention: No intervention involved
|
Survey
N=542
Observational, no intervention: No intervention involved
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
42
|
688
|
|
Overall Study
COMPLETED
|
28
|
42
|
542
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
146
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some participants left this survey item blank
Baseline characteristics by cohort
| Measure |
Survey
n=688 Participants
N=542
Observational, no intervention: No intervention involved
|
Total
n=758 Participants
Total of all reporting groups
|
Focus Groups
n=28 Participants
N=28
Observational, no intervention: No intervention involved
|
Cognitive Interviews
n=42 Participants
N=40
Observational, no intervention: No intervention involved
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=688 Participants
|
4 Participants
n=758 Participants
|
4 Participants
n=28 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
688 Participants
n=688 Participants
|
754 Participants
n=758 Participants
|
24 Participants
n=28 Participants
|
42 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=688 Participants
|
0 Participants
n=758 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
462 Participants
n=518 Participants • Some participants left this survey item blank
|
521 Participants
n=588 Participants • Some participants left this survey item blank
|
23 Participants
n=28 Participants • Some participants left this survey item blank
|
36 Participants
n=42 Participants • Some participants left this survey item blank
|
|
Sex: Female, Male
Male
|
56 Participants
n=518 Participants • Some participants left this survey item blank
|
67 Participants
n=588 Participants • Some participants left this survey item blank
|
5 Participants
n=28 Participants • Some participants left this survey item blank
|
6 Participants
n=42 Participants • Some participants left this survey item blank
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=688 Participants
|
33 Participants
n=758 Participants
|
0 Participants
n=28 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
510 Participants
n=688 Participants
|
546 Participants
n=758 Participants
|
0 Participants
n=28 Participants
|
36 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
151 Participants
n=688 Participants
|
179 Participants
n=758 Participants
|
28 Participants
n=28 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=688 Participants
|
3 Participants
n=758 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=688 Participants
|
14 Participants
n=758 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=688 Participants
|
4 Participants
n=758 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=688 Participants
|
23 Participants
n=758 Participants
|
1 Participants
n=28 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
485 Participants
n=688 Participants
|
546 Participants
n=758 Participants
|
25 Participants
n=28 Participants
|
36 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=688 Participants
|
11 Participants
n=758 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
157 Participants
n=688 Participants
|
157 Participants
n=758 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: At the time of survey completionPopulation: Only those in the Survey Arm (Group 3) participated in the survey for validation
Local and national survey results, cognitive interviews and validation of Down syndrome health measure (DSHM) using psychometric analysis and factor analysis
Outcome measures
| Measure |
Focus Groups
N=28
Observational, no intervention: No intervention involved
|
Cognitive Interviews
N=42
Observational, no intervention: No intervention involved
|
Survey
n=542 Participants
N=542
Observational, no intervention: No intervention involved
|
|---|---|---|---|
|
Number of Completed Surveys for Validation Analysis
|
0 Participants
|
0 Participants
|
542 Participants
|
SECONDARY outcome
Timeframe: At the time of focus group completionPopulation: Only those in focus groups (Group 1) participated in the focus groups
Descriptive focus group results regarding health views. Outline of the preliminary conceptual model
Outcome measures
| Measure |
Focus Groups
n=28 Participants
N=28
Observational, no intervention: No intervention involved
|
Cognitive Interviews
N=42
Observational, no intervention: No intervention involved
|
Survey
N=542
Observational, no intervention: No intervention involved
|
|---|---|---|---|
|
Number of Focus Group Participants Who Participated to Make the Conceptual Model
|
28 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the time of cognitive interviewPopulation: Only those in the cognitive interviews (Group 2) participated in the interviews
Outcome measures
| Measure |
Focus Groups
N=28
Observational, no intervention: No intervention involved
|
Cognitive Interviews
n=42 Participants
N=42
Observational, no intervention: No intervention involved
|
Survey
N=542
Observational, no intervention: No intervention involved
|
|---|---|---|---|
|
Number of Completed Cognitive Interviews
|
0 Participants
|
42 Participants
|
0 Participants
|
Adverse Events
Focus Groups
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Survey
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place