Leveraging Social Networks to Improve Sleep and Mindfulness Among Older Adults in Residential Housing Facilities

The aim of this study is to design a sleep and mindfulness intervention to improve sleep, quality of life, and cognitive function among older adults.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Sleep; Aging
• Intervention / Treatment: Behavioral: Sleep health and mindfulness intervention

Detailed Description

The proposed R34 planning grant will the design and adapt a sleep, mindfulness, and sleep disorders education intervention entitled to cognitively unimpaired older adults residing in housing facilities. Novel, social network techniques will be used to identify opinion leaders who will assist with message dissemination. This grant will adapt content from an existing, evidence-based Sleep Health Program to the needs of older adults. In addition, the adapted Sleep Health Program will be coupled with Mindfulness content then disseminated in a small pilot study to ascertain feasibility and acceptability of the proposed novel social network approach for deploying the adapted Sleep Health and Mindfulness Program in a planned R01. The data collected in this R34 will include qualitative interview and usability interview data where cognitively unimpaired older adults will be recruited and asked to provide input to the messages and approach. Target outcomes will also be collected in the planned pilot, including survey responses to sleep, sleep disorders evaluation/care, quality of life, and cognition. Finally, FitBit data will also be captured for 2 weeks at several time points during the pilot study (baseline, 2-months, and 6-months).

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chidera Ejikeme; Phone Number: 2039792338; Email: cejikeme@bwh.harvard.edu
• Study Contact Backup: Name: Rebecca Robbins, PhD; Phone Number: 2039792338; Email: rrobbins4@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Rebecca Robbins, PhD; Phone Number: 2039792338; Email: rrobbins4@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Older adults (age 55 years of age and above) residing in residential facilities.

Exclusion Criteria:

• Severe cognitive impairment according to the Montreal Cognitive Assessment (MoCA).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sleep Health and Mindfulness Program for Older Adults; This grant will develop and design an adapted version of an existing, effective Sleep Health Program, which will be coupled with mindfulness content, to meet the needs and unique barriers older adults in housing facilities face. The modules for the proposed Sleep Health and Mindfulness program will be designed in collaboration with the implementation partner, the City of Boston Age Strong Commission, whose talented leaders and staff have decades of experience designing programs for seniors on a variety of topics, including mindfulness.

Behavioral: Sleep health and mindfulness intervention; This educational, healthy lifestyle intervention will include several modules detailing sleep health and mindfulness strategies. In addition, opinion leaders will be identified in the population to help diffuse messages through each housing facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time it takes to recruit	Time it takes to recruit participants into the study	Baseline, 2-months, and 6-months
Sessions attended	Average number of sessions the participants attend.	Baseline, 2-months, and 6-months
Proportion of participants who complete the program	Proportion of older adults who complete the program.	Baseline, 2-months, and 6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score of the Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).	Baseline, 2-months, and 6-months
The Score of the Dementia Quality of Life (DEMQOL)	The Dementia Quality of Life (DEMQOL) instrument is a 28-item self-reported measure related to health-related quality-of-life (HRQL) in patients with dementia. The DEMQOL takes cognition, negative emotion, positive emotion, social relationships, and loneliness into consideration.	Baseline, 2-months, and 6-months
The Score of the Montreal Cognitive Assessment (MoCA)	The MoCA (Montreal Cognitive Assessment) test is scored out of 30 points, and a score of 26 or above is generally considered normal. A score of 26 or below may indicate some degree of cognitive impairment. The specific cutoff score for determining impairment is 26.	Baseline, 2-months, and 6-months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Aging (NIA)
• Investigators: Study Chair: Rebecca Robbins, PhD, PhD

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: May 4, 2025
• First Submitted That Met QC Criteria: May 16, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Behavioral intervention; Healthy lifestyle; Sleep health
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: BrighamHopsital; R34AG089176 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data collected in this R34 will be fully anonymous. Data and metadata will be made available through the NIH-funded National Sleep Research Resource (NSRR; www.SleepData.org). Data and metadata will be assigned a unique Digital Object Identifier (DOI) and a formal study citation by the repository (NSRR). All de-identified data will be shared by end of project period or time of publication, whichever is sooner, and will remain available indefinitely. We estimate data will be shared no later than year 2 of this R34 planning grant.
• IPD Sharing Time Frame: All de-identified data will be shared by end of project period or time of publication, whichever is sooner, and will remain available indefinitely. We estimate data will be shared no later than year 2 of this R34 planning grant.
• IPD Sharing Access Criteria: Consistent with the Brigham and Women's Hospital data sharing guidelines
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No