A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Behavioral: sleep education program

• Registration Number: NCT05102565
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This study aims to refine and evaluate feasibility of a telehealth intervention for persons with Alzheimer's disease and their caregivers. The intervention will use evidence-based techniques for decreasing symptoms of depression, anxiety, and poor sleep, that are commonly reported among this vulnerable group during the COVID-19 pandemic. Improved symptoms among this group may improve their other health outcomes and quality of life and furthermore the quality of care that caregivers provide for persons with Alzheimer's disease during this challenging time.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-28
• Study First Submitted: 2021-10-09
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-01
• Primary Completion: 2023-05-18
• Study Completion: 2023-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Inclusion criteria for patients

• Have a diagnosis of AD (probable or possible), other related dementia, or mild cognitive impairment as documented in electronic medical record
• Community-dwelling
• Aged > 50 years
• Have no previously diagnosed sleep disorders (e.g., sleep apnea, restless legs syndrome)
• Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
• Have an eligible caregiver

Inclusion criteria for caregivers

• Aged >18 years
• Live with the eligible patient
• Have regularly assisted the care recipient with >1 of 7 basic activities of daily living (ADLs; i.e., eating, dressing/undressing, grooming, walking across a room, getting in and out of bed, bathing, toileting) or >1 of 7 Instrumental ADL (IADLs; i.e., using the telephone, getting to places beyond walking distance, shopping, preparing meals, doing housework, taking medicine, handling money) for the past 6 months
• Have no history of cognitive impairment
• Can communicate in English.

Exclusion Criteria

-Professional caregivers will be excluded. Patients will be excluded if they are bedbound. If the eligibility criteria for either a patient or a caregiver are not met, their dyads will be excluded for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	sleep education program	6 weekly sleep education program

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index score	immediately after the last session of the intervention	Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality.
Sleep efficiency-Actigraphy	immediately after the last session of the intervention	Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality

Secondary Outcome Measures

Name	Time	Method
Total scores on the Patient Health Questionnaire-9	immediately after the last session of the intervention	Total scores on the Patient Health Questionnaire-9 for caregivers. Range from from 0 to 27 with higher scores indicating worse depressive symptoms among caregivers
Total scores on the Rating Anxiety in Dementia	immediately after the last session of the intervention	Total scores on the Rating Anxiety in Dementia for patients. Range from 0 to 54 with higher scores indicating worse anxiety among persons with dementia
Total scores on the Generalized Anxiety Disorder-7	immediately after the last session of the intervention	Total scores on the Generalized Anxiety Disorder-7 for caregivers. Range from 0 to 21 with higher scores indicating worse anxiety among caregivers
Total scores on the Cornell Scale for Depression in Dementia	immediately after the last session of the intervention	Total scores on the Cornell Scale for Depression in Dementia. Range from 0 to 38 with higher scores indicating worse depressive symptoms among persons with dementia

Trial Locations

Locations (1)

Yeonsu Song; 🇺🇸 Los Angeles, California, United States