A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep

Intervention / Treatment
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* Behavioral: sleep education program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>6 weekly sleep education program | Behavioral: sleep education program<br>* A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, caregivers, COVID-19 pandemic