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NCT Number: NCT06989619

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Rebecca Robbins, PhD

CONTACT

[email protected]

2039792338

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sleep health and mindfulness intervention

Behavioral

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.

Primary outcomes

  1. Time it takes to recruit

    Time frame: Baseline, 2-months, and 6-months

    Time it takes to recruit participants into the study

  2. Sessions attended

    Time frame: Baseline, 2-months, and 6-months

    Average number of sessions the participants attend.

  3. Proportion of participants who complete the program

    Time frame: Baseline, 2-months, and 6-months

    Proportion of older adults who complete the program.

Secondary outcomes

  1. The score of the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, 2-months, and 6-months

    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).

  2. The Score of the Dementia Quality of Life (DEMQOL)

    Time frame: Baseline, 2-months, and 6-months

    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.

  3. The Score of the Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline, 2-months, and 6-months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chidera Ejikeme

CONTACT

[email protected]

2039792338

Rebecca Robbins, PhD

CONTACT

[email protected]

2039792338

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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