Clinical trial NCT03455569: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Alzheimer Disease
Keywords: Behavioral sleep management
Alzheimer's disease
Informal caregiver
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Sleep efficiency for Alzheimer's disease patients
timeFrame: 3 months after the last session of the sleep intervention
measure: Total wake time for Alzheimer's disease patients
timeFrame: 3 months after the last session of the sleep intervention
measure: Sleep quality for caregivers
timeFrame: 3 months after the last session of the sleep intervention
Secondary outcomes:
measure: Cognitive function for Alzheimer's disease patients
timeFrame: 3 months after the last session of the sleep intervention
measure: Problematic behaviors for Alzheimer's disease patients
timeFrame: 3 months after the last session of the sleep intervention
measure: Depression for Alzheimer's disease patients
timeFrame: 3 months after the last session of the sleep intervention
measure: Caregiver burden for caregivers
timeFrame: 3 months after the last session of the sleep intervention
measure: Stress for caregivers
timeFrame: 3 months after the last session of the sleep intervention
measure: Depression for caregivers
timeFrame: 3 months after the last session of the sleep intervention
measure: Inflammation for caregivers
timeFrame: 3 months after the last session of the sleep intervention
measure: Quality of life for Alzheimer's disease patients
timeFrame: 3 months after the last session of the sleep intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: North Hills
country: United States
facility: Veterans Affairs Greater Los Angeles Healthcare System
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Yeonsu Song, PhD
role: PRINCIPAL_INVESTIGATOR
References: