Clinical trial NCT05102565: A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers
Official title: A Dyadic Telehealth Program to Support Alzheimer's Disease Patients and Their Caregivers During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: dementia
caregivers
COVID-19 pandemic
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep efficiency-Actigraphy
timeFrame: immediately after the last session of the intervention
measure: Pittsburgh Sleep Quality Index score
timeFrame: immediately after the last session of the intervention
Secondary outcomes:
measure: Total scores on the Cornell Scale for Depression in Dementia
timeFrame: immediately after the last session of the intervention
measure: Total scores on the Patient Health Questionnaire-9
timeFrame: immediately after the last session of the intervention
measure: Total scores on the Rating Anxiety in Dementia
timeFrame: immediately after the last session of the intervention
measure: Total scores on the Generalized Anxiety Disorder-7
timeFrame: immediately after the last session of the intervention
Other outcomes:
measure: Attrition rate
timeFrame: immediately after the posttreatment assessment
measure: Adherence to homework
timeFrame: immediately after the last session of the intervention
measure: Interventionist adherence
timeFrame: immediately after the last session of the intervention
Locations:
city: Los Angeles
country: United States
facility: Yeonsu Song
state: California
Study officials:
References: