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A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers

Primary Purpose

Sleep, Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral sleep education
Education only
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep focused on measuring Behavioral sleep management, Alzheimer's disease, Informal caregiver

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Alzheimer's disease (AD) patients:

  • AD diagnosis OR probable or possible AD as documented in electronic medical record, which includes Mini Mental State Exam score >12 (indicating mild to moderate severity of AD) and neuroimaging evidence
  • Community-dwelling
  • >1 sleep problem >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale
  • Aged >60 years
  • Able to ambulate with or without assistive device
  • Have an eligible caregiver (see below)

Inclusion Criteria for caregivers:

  • Live with an eligible patient
  • Aged >21 years
  • Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs) (i.e., bathing, dressing, toileting, transfers, continence, feeding) or >1 of 8 Instrumental ADL (IADLs) (i.e., using the telephone, shopping, preparing meals, housekeeping, laundry, transportation, taking medicine, managing money) for the past 6 months
  • Pittsburgh Sleep Quality Index (PSQI) total score >5
  • Montreal Cognitive Assessment (MoCA) score >= 23
  • Can communicate in English

Exclusion Criteria:

- If AD patient is bed bound

Sites / Locations

  • University of California Los Angeles
  • Veterans Affairs Greater Los Angeles Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Behavioral sleep education

Education only

Arm Description

manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

education on sleep, aging, and dementia but without specific or individualized recommendations

Outcomes

Primary Outcome Measures

Sleep efficiency for Alzheimer's disease patients
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 3 days of wrist actigraphy
Total wake time for Alzheimer's disease patients
Total wake time (mean total minutes awake from sleep onset to get up time) will be calculated from 3 days of wrist actigraphy
Sleep quality for caregivers
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality

Secondary Outcome Measures

Cognitive function for Alzheimer's disease patients
Total score on the Alzheimer's Disease Assessment Scale-Cognitive Subscale test will be used as a measure of cognitive function
Problematic behaviors for Alzheimer's disease patients
Total score on the Revised Memory and Behavior Problem Checklist will be used as a measure of problematic behaviors
Depression for Alzheimer's disease patients
Total score on the Cornell Scale for Depression in Dementia will be used as a measure of depression
Caregiver burden for caregivers
Total score on the Zarit Burden Interview will be used as a measure of caregiver burden
Stress for caregivers
Total score on the Perceived Stress Scale will be used as a measure of stress
Depression for caregivers
Total score on the Center for Epidemiological Study-Depression will be used as a measure of depression
Inflammation for caregivers
Levels of C-reactive protein and gene expression of inflammation will be measured
Quality of life for Alzheimer's disease patients
Total score on the Quality of Life-Alzheimer's Disease Scale will be used as a measure of quality of life

Full Information

First Posted
February 28, 2018
Last Updated
August 15, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03455569
Brief Title
A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
Official Title
A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Studies consistently show the negative health impact of sleep problems in both Alzheimer's disease (AD) patients and their caregivers. However, only a few sleep interventions have been conducted for AD patients or their caregivers in community settings and none have addressed both members of the dyad concurrently. To fill these gaps, this study aims to develop a sleep intervention program specifically tailored for AD patient/caregiver dyads who both experience sleep difficulties.
Detailed Description
In 2015, Americans provided 18 billion hours of unpaid care for patients with Alzheimer's disease (AD) and other dementias, with an economic value of $221 billion. This estimate may be even higher among caregivers of AD patients when they have sleep problems. In fact, the caregivers' sleep is often disturbed by nighttime sleep disturbance of AD patients, which is one of the major reasons why those patients are admitted to institutions. Due to the bidirectional nature of sleep disturbance in AD patients and their caregivers, it is critical to develop a sleep intervention program for the dyad that addresses sleep disturbance in both individuals. Nighttime sleep disturbance in AD patients is associated with shorter survival, lower quality of life, and decreased social engagement. Poor sleep among their caregivers is associated with increased depressive symptoms, higher levels of caregiver role burden, and increased inflammation, which is known to increase risk for cardiovascular disease. Such decline in caregivers' health may then impact the quality of care for AD patients. Behavioral sleep intervention programs for AD patients or caregivers are feasible but long-term effects on improving sleep and health remain unclear. No behavioral sleep interventions have focused on the patient-caregiver dyad, and only a few behavioral sleep intervention studies have targeted community-dwelling AD patients or caregivers. Dyad-based sleep interventions may have better effects on sleep and other health outcomes because of the influence of AD patients on their caregivers and vice versa. The proposed intervention focuses on educating caregivers to improve their own and the patients' sleep, using behavioral sleep management techniques. This intervention builds upon a previous caregiver focus group study (VA HSR&D LIP 65-154, PI: Song) and the existing sleep interventional research studies, which included patients with mild cognitive impairments and AD patients. The sleep program involves 4 face-to-face meetings plus 1 telephone session. Phase 1 study aims to iteratively refine and finalize the intervention program materials with 5 AD patient/caregiver dyads. Phase 2 study aims to pilot test the effects of the intervention program (n=20 dyads) on sleep, health, and quality of life in both members of the group, compared to a non-directive education-only control program (n=20 dyads) in a small randomized controlled trial. Primary outcomes will include objective sleep efficiency and total wake time measured by actigraphy for AD patients and subjective sleep measured by the Pittsburgh Sleep Quality Index for caregivers. A unique aspect of the proposed study is that the program is tailored to address sleep problems of both patients and caregivers, and includes upstream biomarkers to evaluate a key mechanism of intervention benefits that can be further explored in future research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Alzheimer Disease
Keywords
Behavioral sleep management, Alzheimer's disease, Informal caregiver

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral sleep education
Arm Type
Experimental
Arm Description
manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Arm Title
Education only
Arm Type
Experimental
Arm Description
education on sleep, aging, and dementia but without specific or individualized recommendations
Intervention Type
Behavioral
Intervention Name(s)
Behavioral sleep education
Intervention Description
This group will receive manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Intervention Type
Behavioral
Intervention Name(s)
Education only
Intervention Description
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
Primary Outcome Measure Information:
Title
Sleep efficiency for Alzheimer's disease patients
Description
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 3 days of wrist actigraphy
Time Frame
3 months after the last session of the sleep intervention
Title
Total wake time for Alzheimer's disease patients
Description
Total wake time (mean total minutes awake from sleep onset to get up time) will be calculated from 3 days of wrist actigraphy
Time Frame
3 months after the last session of the sleep intervention
Title
Sleep quality for caregivers
Description
Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality
Time Frame
3 months after the last session of the sleep intervention
Secondary Outcome Measure Information:
Title
Cognitive function for Alzheimer's disease patients
Description
Total score on the Alzheimer's Disease Assessment Scale-Cognitive Subscale test will be used as a measure of cognitive function
Time Frame
3 months after the last session of the sleep intervention
Title
Problematic behaviors for Alzheimer's disease patients
Description
Total score on the Revised Memory and Behavior Problem Checklist will be used as a measure of problematic behaviors
Time Frame
3 months after the last session of the sleep intervention
Title
Depression for Alzheimer's disease patients
Description
Total score on the Cornell Scale for Depression in Dementia will be used as a measure of depression
Time Frame
3 months after the last session of the sleep intervention
Title
Caregiver burden for caregivers
Description
Total score on the Zarit Burden Interview will be used as a measure of caregiver burden
Time Frame
3 months after the last session of the sleep intervention
Title
Stress for caregivers
Description
Total score on the Perceived Stress Scale will be used as a measure of stress
Time Frame
3 months after the last session of the sleep intervention
Title
Depression for caregivers
Description
Total score on the Center for Epidemiological Study-Depression will be used as a measure of depression
Time Frame
3 months after the last session of the sleep intervention
Title
Inflammation for caregivers
Description
Levels of C-reactive protein and gene expression of inflammation will be measured
Time Frame
3 months after the last session of the sleep intervention
Title
Quality of life for Alzheimer's disease patients
Description
Total score on the Quality of Life-Alzheimer's Disease Scale will be used as a measure of quality of life
Time Frame
3 months after the last session of the sleep intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Alzheimer's disease (AD) patients: AD diagnosis OR probable or possible AD as documented in electronic medical record, which includes Mini Mental State Exam score >12 (indicating mild to moderate severity of AD) and neuroimaging evidence Community-dwelling >1 sleep problem >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale Aged >60 years Able to ambulate with or without assistive device Have an eligible caregiver (see below) Inclusion Criteria for caregivers: Live with an eligible patient Aged >21 years Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs) (i.e., bathing, dressing, toileting, transfers, continence, feeding) or >1 of 8 Instrumental ADL (IADLs) (i.e., using the telephone, shopping, preparing meals, housekeeping, laundry, transportation, taking medicine, managing money) for the past 6 months Pittsburgh Sleep Quality Index (PSQI) total score >5 Montreal Cognitive Assessment (MoCA) score >= 23 Can communicate in English Exclusion Criteria: - If AD patient is bed bound
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeonsu Song, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Veterans Affairs Greater Los Angeles Healthcare System
City
North Hills
State/Province
California
ZIP/Postal Code
91343
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
After the primary outcome is published

Learn more about this trial

A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers

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