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NCT04631237 · ClinicalTrials.gov registry record
Developing a Down Syndrome Health Instrument
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 758
- Enrollment target
NCT04631237: Completed study, sponsored by Massachusetts General Hospital.
NCT04631237 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 758 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04631237 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 758 participants
- Enrollment target
Study Summary
Although over 200,000 individuals with DS live in the United States, studies to date have focused on outcomes apart from health. The foundation for this proposal is based on the need to accurately measure health of all individuals - specifically, with DS - and the dearth of available tools for this population. Creating such an instrument will provide a barometer of the current state of health for DS and hold use in future research. In this project, I propose to create an instrument that directly assesses health in DS - the Down syndrome Health Instrument (DHI). More specifically, the aims of this proposal are: 1. To conduct focus groups among caregivers, individuals with DS, panels of experts on DS and primary care physicians, and cognitive interviews to refine a conceptual model of health for DS and create an item pool, 2. To administer the DHI and establish internal validity, reliability, and external validity of the DHI for use in clinical research, and 3. To test the usability of the DHI in two pilot settings: research and clinical. This instrument will measure patient-reported health in DS for the first time and allow measurement of health as an outcome which is not currently possible in this population. This can identify gaps in care, then direct and optimize interventions that will improve care.
Primary Outcome
Local and national survey results, cognitive interviews and validation of Down syndrome health measure (DSHM) using psychometric analysis and factor analysis
Interventions
- OTHER Observational, no intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 758 participants |
| Start Date | 2020-04-03 |
| Est. Completion | 2025-03-31 |
What the finished NCT04631237 record still lists
NCT04631237 is an observational study that tracks outcomes without assigning an intervention. The registered 758 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Observational, no intervention is the first listed.
NCT04631237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04631237 about?
NCT04631237 is a clinical study titled "Developing a Down Syndrome Health Instrument". Although over 200,000 individuals with DS live in the United States, studies to date have focused on outcomes apart from health. The foundation for this proposal is based on the need to accurately measure health of all individuals - specifically, with DS - and the dearth of available tools for this ...
What is the current status of trial NCT04631237?
This trial is currently completed. The enrollment target is 758 participants. The study started on 2020-04-03. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT04631237?
The interventions under investigation include: Observational, no intervention (OTHER).
Who is sponsoring clinical trial NCT04631237?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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