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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05102565
Enrollment
29
Registered
2021-11-01
Start date
2021-09-28
Completion date
2023-06-30
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

dementia, caregivers, COVID-19 pandemic

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.

Interventions

A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep efficiency-Actigraphyimmediately after the last session of the interventionNighttime 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
Pittsburgh Sleep Quality Index scoreimmediately after the last session of the interventionSelf-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

MeasureTime frameDescription
Total scores on the Patient Health Questionnaire-9immediately after the last session of the interventionTotal 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 Cornell Scale for Depression in Dementiaimmediately after the last session of the interventionTotal 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
Total scores on the Rating Anxiety in Dementiaimmediately after the last session of the interventionTotal 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-7immediately after the last session of the interventionTotal scores on the Generalized Anxiety Disorder-7 for caregivers. Range from 0 to 21 with higher scores indicating worse anxiety among caregivers

Other

MeasureTime frameDescription
Adherence to homeworkimmediately after the last session of the interventionPercent of days that dyad members complete the homework over the course of the intervention program will be measured.
Attrition rateimmediately after the posttreatment assessmentPercent of number of dyads who fail to complete the study both during the intervention and at posttreatment will be measured.
Interventionist adherenceimmediately after the last session of the interventionPercent of completion of delivery of each component in sessions will be measured

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026