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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2023-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Behavioral sleep education

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

Group Type EXPERIMENTAL

Behavioral sleep education

Intervention Type BEHAVIORAL

This group will receive manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Education only

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

Group Type EXPERIMENTAL

Education only

Intervention Type BEHAVIORAL

This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Interventions

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Behavioral sleep education

This group will receive manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Intervention Type BEHAVIORAL

Education only

This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

* 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