Development of Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads

Withdrawn

• Conditions: Alzheimer's Disease

• Registration Number: NCT02506374
• Lead Sponsor: Yale University

Brief Summary

This non-intervention qualitative study will use focus groups to assess the feasibility and acceptability of a proposed intervention for a future study. The focus group will discuss a potential biobehavioral family self-management intervention designed to improve sleep in persons with Alzheimer's disease (PAD) and their caregivers (CG).

Detailed Description

Approximately 16 caregivers of home-based PAD/CG dyads (person with Alzheimer's disease/caregiver dyads) will be recruited from the community. A series of two audiotaped focus groups will be conducted with these caregiver participants. The first focus group will explore perspectives on what constitutes a feasible and acceptable intervention to improve their sleep and associated symptoms. The second focus group will consist of follow up and confirmation of findings from the first focus group. The intervention will be developed and refined based upon focus group findings.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. screen positive on the PROMIS sleep disturbance and associated symptoms measures
2. be a caregiver within a PAD/CG dyad
3. speak/understand English
4. agree to be audiotaped during focus group participation
5. be at least 18 years of age

Exclusion:

1. they negative on the PROMIS sleep disturbance and associated symptoms measures,
2. are not a caregiver within a PAD/CG dyad,
3. do not speak/understand English,
4. refuse to take part in audiotaping of the focus groups,
5. are not at least 18 years of age.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative Output from Focus Groups	1 day	Focus group data will be processed utilizing Atlas.ti software and analyzed using the constant comparative method.

Trial Locations

Locations (1)

Jewish Senior Services; 🇺🇸 Fairfield, Connecticut, United States