A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

A Dyadic Telehealth Program to Support Alzheimer's Disease Patients and Their Caregivers During COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: sleep education program

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Yeonsu Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 6 weekly sleep education program	Behavioral: sleep education program; A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency-Actigraphy	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	immediately after the last session of the intervention
Pittsburgh Sleep Quality Index score	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.	immediately after the last session of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total scores on the Cornell Scale for Depression in Dementia	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	immediately after the last session of the intervention
Total scores on the Patient Health Questionnaire-9	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	immediately after the last session of the intervention
Total scores on the Rating Anxiety in Dementia	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	immediately after the last session of the intervention
Total scores on the Generalized Anxiety Disorder-7	Total scores on the Generalized Anxiety Disorder-7 for caregivers. Range from 0 to 21 with higher scores indicating worse anxiety among caregivers	immediately after the last session of the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attrition rate	Percent of number of dyads who fail to complete the study both during the intervention and at posttreatment will be measured.	immediately after the posttreatment assessment
Adherence to homework	Percent of days that dyad members complete the homework over the course of the intervention program will be measured.	immediately after the last session of the intervention
Interventionist adherence	Percent of completion of delivery of each component in sessions will be measured	immediately after the last session of the intervention

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 9, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: dementia; caregivers; COVID-19 pandemic
• Other Study ID Numbers: K23AG055668-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No