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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2024-10-28

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.

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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.

Conditions

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Insomnia Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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education and coaching on developing healthy nighttime sleep and daytime activity behaviors

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.

Group Type OTHER

education and coaching on developing healthy nighttime sleep and daytime activity behaviors

Intervention Type BEHAVIORAL

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.

Interventions

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education and coaching on developing healthy nighttime sleep and daytime activity behaviors

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No