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Trial record 9 of 12438 for:    sleep

Improving Sleep in Veterans and Their CGs (SLEEP-E Dyads)

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ClinicalTrials.gov Identifier: NCT02057068
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : December 5, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Sleep Quality
Intervention Behavioral: SLEEP-E Dyads Intervention
Enrollment 102
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title SLEEP-E Dyads Intervention Wait List Control Group
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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.

During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
Period Title: Overall Study
Started [1] 60 36
Completed 52 28
Not Completed 8 8
Reason Not Completed
Withdrawal by Subject             2             2
Caregiver (CG) Health             0             2
Carepartner (CP) Health             4             2
Lost to Follow-up             2             2
[1]
12 beta test dyads included in the intervention group, thus they were not randomized.
Arm/Group Title SLEEP-E Dyads Intervention Usual Care Group Total
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SLEEP-E Dyads Six-Week Tele-Health Intervention

  1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.
  2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.
  3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).
  4. . SLEEP-E Dyads book
  5. . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching

SLEEP-E Dyads Intervention: Described in arm/group description

During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. Total of all reporting groups
Overall Number of Baseline Participants 60 36 96
Hide Baseline Analysis Population Description
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.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 36 participants 96 participants
70.12  (8.14) 70.11  (9.43) 70.12  (8.61)
[1]
Measure Description:

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.

Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 36 participants 96 participants
Female
30
  50.0%
18
  50.0%
48
  50.0%
Male
30
  50.0%
18
  50.0%
48
  50.0%
[1]
Measure Analysis Population Description: This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 60 participants 36 participants 96 participants
60
 100.0%
36
 100.0%
96
 100.0%
1.Primary Outcome
Title Subjective Sleep Quality
Hide Description 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.
Time Frame Baseline (T1) and Post-Intervention (T2) - 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SLEEP-E Dyads Intervention Wait List Control Group
Hide Arm/Group Description:

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.

During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
Overall Number of Participants Analyzed 60 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 8.41  (3.64) 8.31  (4.03)
Post Intervention 5.98  (2.84) 8.63  (4.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SLEEP-E Dyads Intervention, Wait List Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANOVA
Comments Intention to treat analysis with last observation carried forward
Other Statistical Analysis Partial Eta Squared = .282
2.Secondary Outcome
Title Mean Sleep Efficiency
Hide Description 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.
Time Frame Baseline (T1) and Post-Intervention (T2) - 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SLEEP-E Dyads Intervention Usual Care Group
Hide Arm/Group Description:

SLEEP-E Dyads Six-Week Tele-Health Intervention

  1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.
  2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.
  3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).
  4. . SLEEP-E Dyads book
  5. . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching

SLEEP-E Dyads Intervention: Described in arm/group description

During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
Overall Number of Participants Analyzed 60 36
Mean (Standard Deviation)
Unit of Measure: percentage of sleep/time in bed
Baseline 82.19  (6.71) 82.55  (5.71)
Post Intervention 81.64  (7.26) 82.09  (6.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SLEEP-E Dyads Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Intention to treat analysis with last observation carried forward
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title BEF-SHI Total Number of Negative Sleep Hygiene Behaviors
Hide Description 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.
Time Frame Baseline (T1) and Post-Intervention (T2) - 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SLEEP-E Dyads Intervention Usual Care Group
Hide Arm/Group Description:

SLEEP-E Dyads Six-Week Tele-Health Intervention

  1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.
  2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.
  3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).
  4. . SLEEP-E Dyads book
  5. . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching

SLEEP-E Dyads Intervention: Described in arm/group description

During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
Overall Number of Participants Analyzed 60 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.27  (2.21) 4.39  (2.27)
Post Intervention 3.12  (2.08) 4.51  (2.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SLEEP-E Dyads Intervention, Usual Care Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Data were collected throughout the study. There were no adverse events.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SLEEP-E Dyads Intervention Wait List Control Group
Hide Arm/Group Description

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.

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.
All-Cause Mortality
SLEEP-E Dyads Intervention Wait List Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/36 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
SLEEP-E Dyads Intervention Wait List Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SLEEP-E Dyads Intervention Wait List Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/36 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Patricia C. Griffiths, PhD
Organization: Atlanta Department of Veterans Affairs Medical Center CVNR
Phone: 6783615462
EMail: pcgriff@emory.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02057068     History of Changes
Other Study ID Numbers: E7249-W
First Submitted: January 24, 2014
First Posted: February 6, 2014
Results First Submitted: July 13, 2017
Results First Posted: December 5, 2017
Last Update Posted: January 23, 2018