Expired Study
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Fairfield, Connecticut 06825


Purpose:

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).


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

1412015088


NCT ID:

NCT02506374


Secondary ID:


Study Acronym:

BEST-Sleep


Brief Title:

Development of Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Never able to get any subjects enrolled


Study Type:

Observational


Study Design:

Observational Model: Cohort


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:LuAnn Etcher, PhD
Principal Investigator
Yale University

Study Dates

Start Date:November 2014
Completion Date:January 2016
Completion Type:Actual
Primary Completion Date:January 2016
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 11, 2016
First Received Date:July 16, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Qualitative Output from Focus Groups
Time Frame:1 day
Safety Issues:False
Description:Focus group data will be processed utilizing Atlas.ti software and analyzed using the constant comparative method.

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University

Samples and Retentions

Study Population: Caregivers of home-based PAD/CG dyads (person with Alzheimer's disease/caregiver dyads) will be recruited from the community
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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