A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT05102565
Collaborator
(none)
15
1
1
20.3
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: sleep education program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Dyadic Telehealth Program to Support Alzheimer's Disease Patients and Their Caregivers During COVID-19
Actual Study Start Date :
Aug 20, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

Other Outcome Measures

  1. Attrition rate [immediately after the posttreatment assessment]

    Percent of number of dyads who fail to complete the study both during the intervention and at posttreatment will be measured.

  2. Adherence to homework [immediately after the last session of the intervention]

    Percent of days that dyad members complete the homework over the course of the intervention program will be measured.

  3. Interventionist adherence [immediately after the last session of the intervention]

    Percent of completion of delivery of each component in sessions will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Inclusion criteria for patients

  • Have a diagnosis of AD (probable or possible) or other related dementia as documented in electronic medical record

  • Community-dwelling

  • Have >1 sleep problem >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale

  • Aged >60 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 care recipient who has AD or other type(s) of dementia

  • 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 a score ≥5 on the Patient Health Questionnaire (PHQ)-9 for the past 2 weeks

  • Have a score ≥19 on the telephone version of the Montreal Cognitive Assessment (MoCA)

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yeonsu Song Los Angeles California United States 90095

Sponsors and Collaborators

  • University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yeonsu Song, PhD, RN, FNP, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT05102565
Other Study ID Numbers:
  • K23AG055668-04S1
First Posted:
Nov 1, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yeonsu Song, PhD, RN, FNP, Assistant Professor, University of California, Los Angeles

Study Results

No Results Posted as of Jun 30, 2022