Development of Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02506374

Acronym

BEST-Sleep

Enrollment

Registered

2015-07-23

Start date

2014-11-30

Completion date

2016-01-31

Last updated

2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results