A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102565
• Other study ID #: K23AG055668-04S1
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 30, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
United States	Yeonsu Song	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Interventionist adherence	Percent of completion of delivery of each component in sessions will be measured	immediately after the last session of the intervention
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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