Development of Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads

Alzheimer's Disease Clinical Trial

— BEST-Sleep  

Official title:

Project BEST-Sleep: A Pilot Study to Develop a Biobehavioral Self-Management Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02506374
• Other study ID #: 1412015088
• Status: Withdrawn
• Phase: N/A
• First received: July 16, 2015
• Last updated: January 11, 2016
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
United States	Jewish Senior Services	Fairfield	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative Output from Focus Groups	Focus group data will be processed utilizing Atlas.ti software and analyzed using the constant comparative method.	1 day	No