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临床试验/NCT04631237
NCT04631237已完成不适用

Developing a Down Syndrome Health Instrument

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 758 人开始时间: 2020年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
758
试验地点
1
主要终点
Survey results, cognitive interviews, and validation

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Focus Groups

N=52

干预措施: Observational, no intervention (Other)

Cognitive Interviews

N=24

干预措施: Observational, no intervention (Other)

Survey

N=542

干预措施: Observational, no intervention (Other)

结局指标

主要结局

Survey results, cognitive interviews, and validation

时间窗: Within 12 months of completion of analysis of surveys

Local and national survey results, cognitive interviews and validation of DHI

Number of Completed Surveys for Validation Analysis

时间窗: 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

次要结局

  • Focus group results and conceptual model(Within 12 months of completion of focus groups)
  • Number of Focus Group Participants Who Participated to Make the Conceptual Model(At the time of focus group completion)
  • Number of Completed Cognitive Interviews(At the time of cognitive interview)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie Santoro

Assistant Professor of Pediatrics, Clinical Geneticist

Massachusetts General Hospital

研究点 (1)

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