Trial Outcomes & Findings for Improving Sleep in Veterans and Their CGs (NCT NCT02057068)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

Baseline (T1) and Post-Intervention (T2) - 8 Weeks

Results posted on

2018-01-23

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	Wait List Control Group During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
Overall Study STARTED	60	36
Overall Study COMPLETED	52	28
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Wait List Control Group During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
Overall Study Withdrawal by Subject	2	2
Overall Study Caregiver (CG) Health	0	2
Overall Study Carepartner (CP) Health	4	2
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SLEEP-E Dyads Intervention n=60 Participants 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	Usual Care Group n=36 Participants During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.	Total n=96 Participants Total of all reporting groups
Age, Continuous	70.12 Years STANDARD_DEVIATION 8.14 • n=5 Participants	70.11 Years STANDARD_DEVIATION 9.43 • n=7 Participants	70.12 Years STANDARD_DEVIATION 8.61 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants • This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner	18 Participants n=7 Participants • This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner	48 Participants n=5 Participants • This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner
Sex: Female, Male Male	30 Participants n=5 Participants • This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner	18 Participants n=7 Participants • This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner	48 Participants n=5 Participants • This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner
Region of Enrollment United States	60 Participants n=5 Participants	36 Participants n=7 Participants	96 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (T1) and Post-Intervention (T2) - 8 Weeks

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.

Outcome measures

Outcome measures
Measure	SLEEP-E Dyads Intervention n=60 Participants 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.	Wait List Control Group n=36 Participants During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
Subjective Sleep Quality Baseline	8.41 units on a scale Standard Deviation 3.64	8.31 units on a scale Standard Deviation 4.03
Subjective Sleep Quality Post Intervention	5.98 units on a scale Standard Deviation 2.84	8.63 units on a scale Standard Deviation 4.19

SECONDARY outcome

Timeframe: Baseline (T1) and Post-Intervention (T2) - 8 Weeks

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.

Outcome measures

Outcome measures
Measure	SLEEP-E Dyads Intervention n=60 Participants 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.	Wait List Control Group n=36 Participants During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
Mean Sleep Efficiency Baseline	82.19 percentage of sleep/time in bed Standard Deviation 6.71	82.55 percentage of sleep/time in bed Standard Deviation 5.71
Mean Sleep Efficiency Post Intervention	81.64 percentage of sleep/time in bed Standard Deviation 7.26	82.09 percentage of sleep/time in bed Standard Deviation 6.11

SECONDARY outcome

Timeframe: Baseline (T1) and Post-Intervention (T2) - 8 Weeks

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.

Outcome measures

Outcome measures
Measure	SLEEP-E Dyads Intervention n=60 Participants 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.	Wait List Control Group n=36 Participants During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
BEF-SHI Total Number of Negative Sleep Hygiene Behaviors Post Intervention	3.12 units on a scale Standard Deviation 2.08	4.51 units on a scale Standard Deviation 2.12
BEF-SHI Total Number of Negative Sleep Hygiene Behaviors Baseline	5.27 units on a scale Standard Deviation 2.21	4.39 units on a scale Standard Deviation 2.27

Adverse Events

SLEEP-E Dyads Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patricia C. Griffiths, PhD

Atlanta Department of Veterans Affairs Medical Center CVNR

Phone: 6783615462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place