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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Alzheimer Disease; Sleep

Treatments: Behavioral: Education only; Behavioral: Behavioral sleep education

Study type: Interventional

Funder types: Other

Identifiers

NCT03455569

1K23AG055668 (U.S. NIH Grant/Contract)

1K23AG055668-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Behavioral sleep education

Experimental group

Description:

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

Treatment:

Behavioral: Behavioral sleep education

Education only

Experimental group

Description:

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

Treatment:

Behavioral: Education only