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A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

Primary Purpose

Sleep

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Care2Sleep

Sleep Education

About this trial

This is an interventional supportive care trial for Sleep focused on measuring Dementia, Caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Patients

Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
Community-dwelling
>1 sleep problems >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged >60 years
Have no untreated 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 no severe medical conditions with a life expectancy of less than 6 months
Have an eligible caregiver

Inclusion Criteria for Caregivers

Live with an eligible patient
Aged >18 years
Is related to the patient as a family member, a significant other, or a friend
Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or >1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months
Pittsburgh Sleep Quality Index (PSQI) total score >5
Montreal Cognitive Assessment (MoCA) ≥23
Can communicate in English

Exclusion Criteria:

Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.
Paid, professional caregivers will also be excluded.
If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.

Sites / Locations

University of California San DiegoRecruiting
University of California Los AngelesRecruiting
Veterans Affairs Greater Los Angeles Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

In-Person Care2Sleep

Telehealth Care2Sleep

Sleep Education only

Arm Description

In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

In-person, education on sleep, aging, and dementia but without specific or individualized recommendations

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Total score of Revised Memory and Behavior Problem Checklist

Dementia-related problem behaviors among persons with dementia (reported by caregivers). Range from 0 to 96 with higher scores indicating more severe dementia-related behaviors.

Total score of Quality of Life-Alzheimer's Disease Scale

Quality of life among persons with dementia reported by either caregivers or persons with dementia. Range from 4 to 52 with higher scores indicating better quality of life among persons with dementia

Total score of Zarit Burden Interview

Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers

Total score of Center for Epidemiological Study of Depression Scale

Perceived frequency of depressive symptoms during the past week. Ranges from 0 to 60 with higher scores indicating greater levels of depressive symptoms among caregivers

Patient-Reported Outcomes Measurement Information System (PROMIS) global health score

Self-reported physical and mental health scores among caregivers. A T-score of 50 represents the mean of the general population. Higher scores indicate better physical and mental health among caregivers

Levels of inflammatory markers

Three key inflammatory markers including C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6 will be collected among caregivers only

Full Information

NCT ID

NCT05452031

First Posted

July 1, 2022

Last Updated

February 22, 2023

Sponsor

University of California, Los Angeles

Collaborators

University of California, San Diego, VA Greater Los Angeles Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT05452031

Brief Title

A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

Official Title

A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 30, 2022 (Actual)

Primary Completion Date

January 31, 2027 (Anticipated)

Study Completion Date

May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

University of California, San Diego, VA Greater Los Angeles Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep

Keywords

Dementia, Caregivers

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

In-Person Care2Sleep

Arm Type

Experimental

Arm Description

In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Arm Title

Telehealth Care2Sleep

Arm Type

Active Comparator

Arm Description

Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Arm Title

Sleep Education only

Arm Type

Placebo Comparator

Arm Description

In-person, education on sleep, aging, and dementia but without specific or individualized recommendations

Intervention Type

Behavioral

Intervention Name(s)

Care2Sleep

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Sleep Education

Intervention Description

This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Primary Outcome Measure Information:

Title

Sleep efficiency-Actigraphy

Description

Time Frame

Change from Baseline Sleep Efficiency at 6 months

Title

Pittsburgh Sleep Quality Index score

Description

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.

Time Frame

Change from Baseline Pittsburgh Sleep Quality Index score at 6 months

Secondary Outcome Measure Information:

Title

Total score of Revised Memory and Behavior Problem Checklist

Description

Dementia-related problem behaviors among persons with dementia (reported by caregivers). Range from 0 to 96 with higher scores indicating more severe dementia-related behaviors.

Time Frame