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Completed

NCT Number: NCT05102565

A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

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.

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Key information

Conditions

Sleep Brain Diseases COVID-19 Central Nervous System Diseases Coronaviridae Infections Coronavirus Infections Dementia Infections Lung Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeonsu Song

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Education Program

Behavioral

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

Primary outcomes

  1. Sleep efficiency-Actigraphy

    Time frame: 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

    Time frame: 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 outcomes

  1. Total scores on the Cornell Scale for Depression in Dementia

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Attrition rate

    Time frame: 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

    Time frame: 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

    Time frame: immediately after the last session of the intervention

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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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