Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults

Study Overview
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Brief Summary
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To finalize daytime intervention components for a comprehensive sleep-wake intervention for frail older adults and explore feasibility and acceptability using a pilot trial.

Detailed Description
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An enhanced intervention addressing both nighttime and daytime activities will be developed based on prior evidence and further informed by data. A successive cohort design will be utilized to evaluate and refine key intervention components and gather feedback on older adults' experiences.

Official Title
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Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older Adults

Conditions
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Insomnia Disorder

Intervention / Treatment
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* Behavioral: education and coaching on developing healthy nighttime sleep and daytime activity behaviors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 or over One or more outpatient primary care visits to Wake Forest Baptist Health in the prior 12 months Meets diagnostic criteria for Insomnia Disorder Less than 30 minutes of daily activity or less than 150 minutes total weekly activity for one month or longer, as reported on brief telephone screener Able to ambulate safely (with or without an assistive device) Able to follow study directions Able to communicate and follow study instructions English speaking Exclusion Criteria: Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg syndrome) Serious or unstable medical or psychiatric condition that would prevent participation in a behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder, substance abuse disorder) Lack of decision-making capacity, as documented in medical record Referred to institutional care and/or currently residing in a nursing home or other residential facility

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All participants enrolled in the pilot trial will receive the intervention, all activities will be unblinded. Older adults utilizing outpatient primary care clinics belonging Atrium Wake Forest Baptist Health. All activities will take place within a clinical setting. Participants will be asked to monitor their sleep-activity behaviors while at home.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: education and coaching on developing healthy nighttime sleep and daytime activity behaviors<br>The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors. | Behavioral: education and coaching on developing healthy nighttime sleep and daytime activity behaviors<br>* The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | Total time asleep/total time in bed, per wrist actigraph | Month 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity scores | Insomnia Severity Index (ISI) is a 7-item validated, self-report questionnaire used to evaluate insomnia severity. Scores range from 0 - 28, higher scores indicate more severe insomnia symptom severity. | Month 2 | 
| total daytime activity | Daily activity (total count), per wrist actigraph | Month 2 | 
| daytime consequences | per self-reported assessment, daily diary | Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep-wake patterns, poor sleep