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Trial record 43 of 279 for:    Best Disease

Development of Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads (BEST-Sleep)

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ClinicalTrials.gov Identifier: NCT02506374
Recruitment Status : Withdrawn (Never able to get any subjects enrolled)
First Posted : July 23, 2015
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Alzheimer's Disease

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Official Title: Project BEST-Sleep: A Pilot Study to Develop a Biobehavioral Self-Management Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads
Study Start Date : November 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Caregivers of home-based PAD/CG dyads (person with Alzheimer's disease/caregiver dyads) will be recruited from the community
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506374


Locations
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United States, Connecticut
Jewish Senior Services
Fairfield, Connecticut, United States, 06825
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: LuAnn Etcher, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02506374     History of Changes
Other Study ID Numbers: 1412015088
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders