R01AG076756
Project Grant
Overview
Grant Description
A Dyadic Approach to Improve Sleep and Well-being Among Persons with Alzheimer's Disease and Their Caregivers - Project Summary/Abstract
Poor sleep is very common in persons with Alzheimer's disease and related dementias (ADRD) and their caregivers. It is significantly associated with adverse mental and physical health outcomes and well-being in both members of the group. Unmanaged poor sleep will further impact the quality of care that the caregivers provide for the patients. This suggests a critical need of sleep management in this vulnerable population.
Unfortunately, an intervention addressing sleep problems of both members of the dyad simultaneously is lacking, particularly using the behavioral strategies that have been effective in other groups. Effects of sleep intervention programs in different delivery modalities are also unknown in this group.
The current proposal aims to examine the efficacy of a dyadic sleep intervention program for ADRD patients and their caregivers, that is built upon PI's prior work. We propose a 3-arm randomized controlled trial design (Stage II), including both in-person (N=70 dyads) and telehealth (N=70 dyads) delivery of the intervention, compared to in-person sleep education control (N=70 dyads).
The dyadic intervention is a 5-week, manual-based program, which incorporates key components of cognitive behavioral therapy for insomnia, daily light exposure and walking, and a problem-solving approach for ADRD-related problematic nighttime behaviors and other caregiving challenges. All intervention sessions will be delivered by a sleep educator.
Primary outcomes include subjective and objective sleep quality of the dyads. Secondary outcomes include the patients' dementia-related behaviors and quality of life, and the caregivers' burden, depression, and perceived health. We will also explore effects of the dyadic sleep program on inflammatory markers among caregivers.
All outcomes will be measured at baseline, post-intervention (i.e., immediately after the last session of the intervention), and 6-month after the last session. Both superior (both in-person and telehealth interventions versus control) and non-inferior effects (in-person versus telehealth intervention) will be tested.
A unique aspect of the proposed work is that the program is tailored to address sleep problems of both patients and caregivers, and includes inflammatory biomarkers to evaluate a key mechanism of intervention benefits that can be further explored in future research.
The knowledge gained from this study has the potential to improve the lives of ADRD patients and their caregivers. Our dyadic sleep intervention can be disseminated to multiple communities serving ADRD patients and/or caregivers, including those that lack access to traditional in-person sleep treatment. The intervention manual can also be used to train health professionals and staff in various types of community programs.
Poor sleep is very common in persons with Alzheimer's disease and related dementias (ADRD) and their caregivers. It is significantly associated with adverse mental and physical health outcomes and well-being in both members of the group. Unmanaged poor sleep will further impact the quality of care that the caregivers provide for the patients. This suggests a critical need of sleep management in this vulnerable population.
Unfortunately, an intervention addressing sleep problems of both members of the dyad simultaneously is lacking, particularly using the behavioral strategies that have been effective in other groups. Effects of sleep intervention programs in different delivery modalities are also unknown in this group.
The current proposal aims to examine the efficacy of a dyadic sleep intervention program for ADRD patients and their caregivers, that is built upon PI's prior work. We propose a 3-arm randomized controlled trial design (Stage II), including both in-person (N=70 dyads) and telehealth (N=70 dyads) delivery of the intervention, compared to in-person sleep education control (N=70 dyads).
The dyadic intervention is a 5-week, manual-based program, which incorporates key components of cognitive behavioral therapy for insomnia, daily light exposure and walking, and a problem-solving approach for ADRD-related problematic nighttime behaviors and other caregiving challenges. All intervention sessions will be delivered by a sleep educator.
Primary outcomes include subjective and objective sleep quality of the dyads. Secondary outcomes include the patients' dementia-related behaviors and quality of life, and the caregivers' burden, depression, and perceived health. We will also explore effects of the dyadic sleep program on inflammatory markers among caregivers.
All outcomes will be measured at baseline, post-intervention (i.e., immediately after the last session of the intervention), and 6-month after the last session. Both superior (both in-person and telehealth interventions versus control) and non-inferior effects (in-person versus telehealth intervention) will be tested.
A unique aspect of the proposed work is that the program is tailored to address sleep problems of both patients and caregivers, and includes inflammatory biomarkers to evaluate a key mechanism of intervention benefits that can be further explored in future research.
The knowledge gained from this study has the potential to improve the lives of ADRD patients and their caregivers. Our dyadic sleep intervention can be disseminated to multiple communities serving ADRD patients and/or caregivers, including those that lack access to traditional in-person sleep treatment. The intervention manual can also be used to train health professionals and staff in various types of community programs.
Funding Goals
NOT APPLICABLE
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Los Angeles,
California
90095
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 418% from $722,569 to $3,741,400.
Los Angeles University Of California was awarded
Dyadic Sleep Intervention for Alzheimer's Patients and Caregivers
Project Grant R01AG076756
worth $3,741,400
from National Institute on Aging in June 2022 with work to be completed primarily in Los Angeles California United States.
The grant
has a duration of 5 years and
was awarded through assistance program 93.866 Aging Research.
The Project Grant was awarded through grant opportunity Research Project Grant (Parent R01 Clinical Trial Required).
Status
(Ongoing)
Last Modified 7/6/26
Period of Performance
6/15/22
Start Date
5/31/27
End Date
Funding Split
$3.7M
Federal Obligation
$0.0
Non-Federal Obligation
$3.7M
Total Obligated
Activity Timeline
Transaction History
Modifications to R01AG076756
Additional Detail
Award ID FAIN
R01AG076756
SAI Number
R01AG076756-1884439771
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NN00 NIH National Insitute on Aging
Funding Office
75NN00 NIH National Insitute on Aging
Awardee UEI
RN64EPNH8JC6
Awardee CAGE
4B557
Performance District
CA-36
Senators
Dianne Feinstein
Alejandro Padilla
Alejandro Padilla
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Institute on Aging, National Institutes of Health, Health and Human Services (075-0843) | Health research and training | Grants, subsidies, and contributions (41.0) | $1,466,857 | 100% |
Modified: 7/6/26