Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT04631237
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02114, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention involved
Time frame: At the time of survey completion
Local and national survey results, cognitive interviews and validation of Down syndrome health measure (DSHM) using psychometric analysis and factor analysis
Time frame: At the time of focus group completion
Descriptive focus group results regarding health views. Outline of the preliminary conceptual model
Time frame: At the time of cognitive interview
Massachusetts General Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07702201
Abnormalities, Multiple, Chromosome Disorders
Giza, Eldoky, Egypt
View Trial DetailsNCT05662228
Abnormalities, Multiple, Autoimmune Diseases
Los Angeles, California, United States
View Trial DetailsNCT06592404
Abnormalities, Multiple, Autism Spectrum Disorder
Sittard, Limburg, Netherlands
View Trial DetailsNCT06206824
Abnormalities, Multiple, Alzheimer Disease
Gières, France
View Trial Details