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Clinical Trials/NCT02506374
NCT02506374
Withdrawn
Not Applicable

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

Yale University1 site in 1 countryNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Yale University
Locations
1
Primary Endpoint
Qualitative Output from Focus Groups
Status
Withdrawn
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
January 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • screen positive on the PROMIS sleep disturbance and associated symptoms measures
  • be a caregiver within a PAD/CG dyad
  • speak/understand English
  • agree to be audiotaped during focus group participation
  • be at least 18 years of age
  • they negative on the PROMIS sleep disturbance and associated symptoms measures,
  • are not a caregiver within a PAD/CG dyad,
  • do not speak/understand English,
  • refuse to take part in audiotaping of the focus groups,
  • are not at least 18 years of age.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Qualitative Output from Focus Groups

Time Frame: 1 day

Focus group data will be processed utilizing Atlas.ti software and analyzed using the constant comparative method.

Study Sites (1)

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