Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
NCT Number: NCT06989619
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.
Interested in participating?
Request Info55 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 2-months, and 6-months
Time it takes to recruit participants into the study
Time frame: Baseline, 2-months, and 6-months
Average number of sessions the participants attend.
Time frame: Baseline, 2-months, and 6-months
Proportion of older adults who complete the program.
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Chidera Ejikeme
CONTACT
Rebecca Robbins, PhD
CONTACT
Brigham and Women's Hospital
Other
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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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