Developing a Down Syndrome Health Instrument

Recruiting

• Conditions: Health, Subjective; Down Syndrome
• Interventions: Other: Observational, no intervention

• Registration Number: NCT04631237
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-03
• Study First Submitted: 2020-10-22
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-10
• Last Update Submitted: 2020-11-10
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

• Primary caregiver of an individual with DS (individual with DS age: <22 years)
• Caregiver age: ≥18 years
• Fluent in written and spoken English
• Able to read and provide informed consent

Exclusion Criteria

• Physical or mental condition of caregiver that would prohibit self-administration of questionnaire
• Mosaic Down syndrome: based on medical record review. If caregiver is uncertain or mosaicism is unknown, we will request additional records.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cognitive Interviews	Observational, no intervention	N=24
Focus Groups	Observational, no intervention	N=52
Survey	Observational, no intervention	N=600

Primary Outcome Measures

Name	Time	Method
Survey results, cognitive interviews, and validation	Within 12 months of completion of analysis of surveys	Local and national survey results, cognitive interviews and validation of DHI

Secondary Outcome Measures

Name	Time	Method
Focus group results and conceptual model	Within 12 months of completion of focus groups	Descriptive focus group results regarding health views. Outline of the preliminary conceptual model

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States