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| Name | Class |
|---|---|
| Emory University | OTHER |
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This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a topic that has important implications for the safety, health, functioning and quality of life of older Veterans living at home and being cared for by a family caregiver (CG). The purpose of the study was to develop and field test non-pharmacological, technology enhanced sleep hygiene, exercise and meditation interventions to improve sleep in Veteran caregiving dyads.The conceptual framework of the intervention incorporated components of cognitive behavioral therapy, psycho-education and self-management support for individuals with chronic conditions with an emphasis on cultivating competence and mastery.
Research Plan:
Sample. Veteran care receivers(CR s) or carepartners (CP) over the age of 60 who require assistance from a spousal or cohabitating caregiver (CG) and Veteran caregivers providing care for a cohabitating carepartner were recruited. Dyads underwent comprehensive baseline assessments consisting of in-person home-based interviews and iPad training (T1) followed by a week-long data collection of contemporaneous actigraphic sleep parameters and twice daily (morning and evening) indices of subjective sleep, activity, mood, behavior and sleep hygiene completed on the Tonic for Health Platform. Dyads were randomly assigned to an immediate intervention or wait-list control group. The immediate group received the intervention described below followed by post-intervention assessments (T2) identical to baseline. Wait-list participants then received the intervention followed by a final post-intervention assessment for the wait-list group only (T3).
Intervention.
Daily Videos: Video modules were delivered daily to the dyads' iPads during the 6-week intervention. All participants received core programming of sleep hygiene education, and guided instruction for daily physical activity enhancement "Move-Out!" and meditation/relaxation/self-care "Stand Down!" sessions individualized to functional ability levels. The baseline data allowed for subsequent compilation and programming of individualized, algorithmically derived, adaptive prescriptions for relevant video modules, sleep hygiene recommendations and cognitive behavioral strategies based upon the three independent streams of objective and subjective data for each dyad member. During the intervention dyads completed brief morning and evening diaries to assess compliance with the intervention and capture daily mood and sleep/sleep hygiene data.
Tele-Video-Conferences: Each dyad participated in two tele-video conferences with the PI. The first was to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call was a check-in, encouragement, reinforcement and coaching call. Dyads were re-assessed following the 6-week intervention.
Evaluations:
Standardized quantitative evaluations regarding the utility of the program were completed following the post-intervention assessments on the iPads. A sub-sample of dyads also participated in qualitative interviews.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLEEP-E Dyads Intervention | Experimental | SLEEP-E Dyads Six-Week Tele-Health Intervention
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| Usual Care Group | No Intervention | During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLEEP-E Dyads Intervention | Behavioral | Described in arm/group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Sleep Quality | Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range from 0 - 21. A total score > 5 (some evidence for 8) is indicative of poor sleep quality. | Baseline (T1) and Post-Intervention (T2) - 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sleep Efficiency | Average sleep efficiency over 7 nights of actigraphic measurement . Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep. | Baseline (T1) and Post-Intervention (T2) - 8 Weeks |
| BEF-SHI Total Number of Negative Sleep Hygiene Behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia C Griffiths, PhD | Atlanta VA Medical and Rehab Center, Decatur, GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033 | United States |
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Participants were excluded from the study if both members of the dyad reported sleeping well (no sleep problems, high sleep quality) during baseline interview and/or had sleep efficiency of 85% or greater as measured by actigraphy during baseline week. Randomization occurred following baseline. Consented=102; Randomization=96.
Recruitment for the intervention occurred between 2014 and 2016. Participants were recruited from the Geriatrics Clinic, the CVNR Caregiver Registry and by referrals from Social Workers and Primary Care.
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| ID | Title | Description |
|---|---|---|
| FG000 | SLEEP-E Dyads Intervention | SLEEP-E Dyads Intervention Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching. |
| FG001 | Wait List Control Group | During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Dyads completed a comprehensive interview followed by a weeklong in-home sleep assessment (actigraphy) and journals. Dyads who didn't complete the week were excluded. Others reported sleeping well and were excluded based on that and/or actigraphic assessments. Dyads were randomized after baseline. Only completers were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | SLEEP-E Dyads Intervention | SLEEP-E Dyads Six-Week Tele-Health Intervention
SLEEP-E Dyads Intervention: Described in arm/group description |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline measures were collected in the home of the dyads by trained interviewers. In addition dyads completed morning and evening daily diaries for 7 days. |
| 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 | Subjective Sleep Quality | Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range from 0 - 21. A total score > 5 (some evidence for 8) is indicative of poor sleep quality. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1) and Post-Intervention (T2) - 8 Weeks |
|
Data were collected throughout the study. There were no adverse events.
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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 | SLEEP-E Dyads Intervention | SLEEP-E Dyads Intervention Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching. There were no adverse events. |
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This was a pilot and feasibility study involving dyads who self-selected into the program. The sample size is small, thus the results should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia C. Griffiths, PhD | Atlanta Department of Veterans Affairs Medical Center CVNR | 6783615462 | pcgriff@emory.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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Randomization to an immediate intervention group or a no-contact wait list control group. Following post intervention assessments the wait-list control group received the intervention.
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This efficacy study was not blinded.
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Total Number of negative sleep hygiene indicators from the BEFSHI - Bedtime Environmental Features and Sleep Hygiene Index (e.g., nighttime caffeine, nighttime snacking-sugar, nicotine, excessive alcohol, excessive daytime napping, television, tablet and computer use in bedroom after 9 pm etc.) Participants are asked to respond yes (1) or no (0) to a series of sleep hygiene behaviors considered detrimental to sleep. Scores are summed. Possible scores range from 0-8 with a greater score indicating a greater number of negative sleep hygiene behaviors endorsed. |
| Baseline (T1) and Post-Intervention (T2) - 8 Weeks |
| Carepartner (CP) Health |
|
| Lost to Follow-up |
|
| BG001 | Usual Care Group | During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Wait List Control Group | During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. |
|
|
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| Secondary | Mean Sleep Efficiency | Average sleep efficiency over 7 nights of actigraphic measurement . Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep. | Posted | Mean | Standard Deviation | percentage of sleep/time in bed | Baseline (T1) and Post-Intervention (T2) - 8 Weeks |
|
|
|
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| Secondary | BEF-SHI Total Number of Negative Sleep Hygiene Behaviors | Total Number of negative sleep hygiene indicators from the BEFSHI - Bedtime Environmental Features and Sleep Hygiene Index (e.g., nighttime caffeine, nighttime snacking-sugar, nicotine, excessive alcohol, excessive daytime napping, television, tablet and computer use in bedroom after 9 pm etc.) Participants are asked to respond yes (1) or no (0) to a series of sleep hygiene behaviors considered detrimental to sleep. Scores are summed. Possible scores range from 0-8 with a greater score indicating a greater number of negative sleep hygiene behaviors endorsed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (T1) and Post-Intervention (T2) - 8 Weeks |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Wait List Control Group | During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. There were no adverse events. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |