Sleep QualitySLEEP-E DyadsNCT02057068

Improving Sleep in Veterans and Their CGs

A study testing SLEEP-E Dyads Intervention in people with Sleep Quality, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Sleep Quality
What is being tested?: SLEEP-E Dyads Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Nov 2014to Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Care recipient must be age 60 and over and require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activities of Daily Living,
have a life expectancy of greater than or equal to six (6) months,
have no plans for transitioning out of home in the next six months,
and have approval from the primary care provider to participate in the research.
Caregivers must live with care recipient
Caregivers must obtain a negative mini-cog assessment or negative TICS-m assessment. Caregivers can be any relation (spouse, child, sibling, friend, etc.) to the care recipient so long as the two are cohabitating.
Caregiver can be any age.
For Phase 2 and Phase 3 of the study, either the care recipient or the caregiver must have difficulty sleeping as indicated by scores on the Insomnia Severity Index.

Who cannot join

Parkinson's with tremor or other movement disorder that would invalidate actigraphy
Untreated diagnosis of sleep apnea or restless leg syndrome
Inability to tolerate actigraphy
CG and CR sleep efficiency > 85% and/or both members of dyad report sleeping well
Caregivers must have a negative screen with the Mini-Cog or the ModifiedTelephone Interview for Cognitive Status (TICS-M) to demonstrate cognitive capacity to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033

Other trials in United States

About this study

Official title: Improving Sleep In Veterans and Their Family Caregivers

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.

Read the detailed description

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.

Conditions: Sleep Quality
Being tested: SLEEP-E Dyads Intervention
Keywords: Caregivers, Telemedicine, Sleep Disorders, Meditation, Cognitive Behavioral Therapy, Activity Enhancement, Technology, Non-pharmacological sleep intervention
Medical subject headings: Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SLEEP-E Dyads InterventionBehavioural
Described in arm/group description

Study groups in NCT02057068
Study group	Role	What they receive
SLEEP-E Dyads Intervention	Experimental	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 Receives: Behavioral: SLEEP-E Dyads Intervention
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Jul 2016

First posted6 Feb 2014 (estimated)
Study startNov 2014
Primary completionJun 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep QualityStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Model description: 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.
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02057068
Sponsor's protocol ID: E7249-W
Acronym: SLEEP-E Dyads
Status last verified: Dec 2017
First submitted: 24 Jan 2014
Last updated: 23 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Sleep In Veterans and Their Family Caregivers
ClinicalTrials.gov ID: NCT02057068
Acronym / sponsor ID: SLEEP-E Dyads / E7249-W
Conditions: Sleep Quality
Keywords: Caregivers, Telemedicine, Sleep Disorders, Meditation, Cognitive Behavioral Therapy, Activity Enhancement, Technology, Non-pharmacological sleep intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Emory University
Study start: Nov 2014 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 6 Feb 2014 (estimated)
Results: Posted 5 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Research Plan:

Intervention.

Evaluations:

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
SLEEP-E Dyads Intervention	Experimental	Behavioral: SLEEP-E Dyads InterventionSLEEP-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
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Care recipient must be age 60 and over and require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activities of Daily Living,
have a life expectancy of greater than or equal to six (6) months,
have no plans for transitioning out of home in the next six months,
and have approval from the primary care provider to participate in the research.
Caregivers must live with care recipient

Key exclusion criteria (5 listed)

Parkinson's with tremor or other movement disorder that would invalidate actigraphy
Untreated diagnosis of sleep apnea or restless leg syndrome
Inability to tolerate actigraphy
CG and CR sleep efficiency > 85% and/or both members of dyad report sleeping well
Caregivers must have a negative screen with the Mini-Cog or the ModifiedTelephone Interview for Cognitive Status (TICS-M) to demonstrate cognitive capacity to provide informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SLEEP-E Dyads InterventionDescribed in arm/group description	Behavioural	SLEEP-E Dyads Intervention

Primary outcome

Subjective Sleep Quality
Time frame: 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.

2 secondary outcomes

Mean Sleep Efficiency
Time frame: Baseline (T1) and Post-Intervention (T2) - 8 Weeks
BEF-SHI Total Number of Negative Sleep Hygiene Behaviors
Time frame: Baseline (T1) and Post-Intervention (T2) - 8 Weeks

Results and safety

Results posted to the registry on 5 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SLEEP-E Dyads Intervention	60	52
Wait List Control Group	36	28

Primary outcome: Subjective Sleep Quality

Time frame: Baseline (T1) and Post-Intervention (T2) - 8 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	SLEEP-E Dyads Intervention n = 60	Wait List Control Group n = 36
Baseline	8.41 (3.64)	8.31 (4.03)
Post Intervention	5.98 (2.84)	8.63 (4.19)

SLEEP-E Dyads Intervention vs Wait List Control Group: p <.001, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data were collected throughout the study. There were no adverse events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SLEEP-E Dyads Intervention	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Wait List Control Group	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricia C Griffiths, PhD principal investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SLEEP-E Dyads Intervention in people with Sleep Quality, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Sleep Quality (time frame: Baseline (T1) and Post-Intervention (T2) - 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.