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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG021332 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| education and coaching on developing healthy nighttime sleep and daytime activity behaviors | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| education and coaching on developing healthy nighttime sleep and daytime activity behaviors | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | Total number of minutes asleep divided by total time in bed measure by wrist actigraph | Month 2 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime M Hughes, PhD, MPH, MSW | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Efficiency | Total number of minutes asleep divided by total time in bed measure by wrist actigraph | Posted | Mean | Standard Deviation | percent | Month 2 |
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Baseline through post-program assessment (month 2)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime M Hughes, PhD, MPH, MSW | Wake Forest University Health Sciences | 336-716 -0835 | jane.hughes@wfusm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2024 | Oct 17, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2025 | Oct 17, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2024 | Jan 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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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.
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|
Daily activity (total count of steps), per wrist actigraph |
| Month 2 |
| Pittsburgh Sleep Quality Index Score | Pittsburgh Sleep Quality Index: Daily Disturbances score using the 3-factor scoring model, per self-reported assessment. Scores range from 0-6. Higher scores indicate more daily disturbance. | Month 2 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Education | Mean | Full Range | years |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 2 |
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| Secondary | Total Daytime Activity | Daily activity (total count of steps), per wrist actigraph | Posted | Mean | Standard Deviation | steps | Month 2 |
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| Secondary | Pittsburgh Sleep Quality Index Score | Pittsburgh Sleep Quality Index: Daily Disturbances score using the 3-factor scoring model, per self-reported assessment. Scores range from 0-6. Higher scores indicate more daily disturbance. | Posted | Mean | Standard Deviation | score on a scale | Month 2 |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D001523 |
| Mental Disorders |