A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

NCT05102565 | Completed

• 1 other identifier: K23AG055668-04S1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

dementia; caregivers; COVID-19 pandemic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Total scores on the Cornell Scale for Depression in Dementia

  immediately after the last session of the intervention

• Total scores on the Patient Health Questionnaire-9

  immediately after the last session of the intervention

• Total scores on the Rating Anxiety in Dementia

  immediately after the last session of the intervention

• Total scores on the Generalized Anxiety Disorder-7

  immediately after the last session of the intervention

Other Outcomes (3)

• Attrition rate

  immediately after the posttreatment assessment

• Adherence to homework

  immediately after the last session of the intervention

• Interventionist adherence

  immediately after the last session of the intervention

Study Arms (1)

Treatment group

EXPERIMENTAL

6 weekly sleep education program

Behavioral: sleep education program

Interventions

sleep education program BEHAVIORAL

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

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Yeonsu Song

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Dementia; COVID-19

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: November 1, 2021
• Study Start: September 28, 2021
• Primary Completion: May 18, 2023
• Study Completion: June 30, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

US (1)