I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorVA Office of Research and Development
About this trial
Sleep is essential to functional recovery in rehabilitation settings; however, sleep is likely to be disrupted during rehabilitation admissions. Adverse effects of these disruptions do not subside after discharge, leading to additional consequences such as poor physical function. Veterans are particularly impacted by poor sleep and medical complexities that can lead to injuries requiring rehabilitative care to support their recovery. This may be more apparent in older Veteran populations. After discharge, Veterans must re-acclimate to their home environment while facing potential changes in their sleep, life engagement (e.g., pleasant activities, physical function), and health. This study will create the I-SLEPT (Integrated Sleep and Life Engagement Program for Transitions) intervention, which will support Veterans by stabilizing their sleep and by maximizing participation in meaningful activities during a critical and vulnerable period of recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to and discharged from VA Boston Community Living Center subacute rehabilitation
English-speaking
Discharged to a home setting
Has capacity and does not have severe cognitive impairment
Disqualifiers
Discharged from Long-Term Care, Hospice and Palliative Care, or Spinal Cord Injury bed specialty
Moderate to severe dementia diagnosis, delirium, or active psychosis
Healthcare proxy is activated in electronic health record
A diagnosis of a disorder of hypersomnolence, non-REM parasomnia, or Nightmare Disorder as indicated in electronic health record
Trial design
Design model
Single group
Treatments tested in this trial
I-SLEPT
BehavioralVeterans in Aim 3 will complete I-SLEPT, a 4-week telehealth intervention, delivered by a licensed clinical psychologist. Sessions will take place once a week for 60 minutes primarily using VA Video Connect. Sessions will include components focused on 1) promoting sleep health through education and habits and 2) increase engagement in meaningful activities.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: I-SLEPTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
RuSATED
A brief 6-item measure encompassing the dimensions of sleep health: Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration. Scores range from 0 to 12 with higher total scores suggesting better sleep health. Items are rated on a 3-point scale from 0 to 2 (with 0 = Rarely/Never; 1 = Sometimes; and 2 = Usually/Always).
Time frame
Baseline, Endpoint (30 day), 3 Month2
What Matters Most (WMM) Tool
A one-page brief tool presenting 3 domains (Staying Independent, Enjoying Life, and Connecting), each containing a list of 9 items with the option of adding a 10th item of their own. Veterans will be asked to identify up to 3 items within each domain that matters most to them. After up to 9 items total have been identified, Veterans will be asked to "pick the most important thing" and describe what this would look like for them "day to day or week to week." Veterans will be encouraged to pick up to 3 things that matter most above all. Finally, Veterans are asked to rate how well they are achieving their life engagement goals and what matters most to them, employing a 5-point Likert-style goal attainment scale (+2 = much better than expected; +1 = a little better than expected; 0 = as expected; -1 = a little worse than expected; -2 = much worse than expected). A score of 0-2 indicate satisfactory goal attainment in the area of life engagement.
Time frame
Baseline, Endpoint (30 day), 3 Month3
Acceptability of Intervention Measure (AIM)
A 4-item measure that assess acceptability, defined here as the perception that I-SLEPT is acceptable, palatable, or satisfactory. Items are scored as follows: 1 - completely disagree; 2 - disagree; 3 - neither agree nor disagree; 4 - agree; 5 - completely agree. Total scores are from 4 to 20 with higher scores indicating better acceptability of the intervention.
Time frame
Endpoint (30 day)4
Feasibility of Intervention Measure (FIM)
A 4-item measure that assesses feasibility defined here as the extent to which the session material can be successfully used - defined as from the Veteran's perspective of applying what is learned after the session. Items are scored as follows: 1 - completely disagree; 2 - disagree; 3 - neither agree nor disagree; 4 - agree; 5 - completely agree. Total scores are from 4 to 20 with higher scores indicating better feasibility of the intervention.
Time frame
Endpoint (30 day)Secondary outcomes
1
Intervention Appropriateness Measure (IAM)
A 4-item measure that assesses appropriateness, defined here as the Veteran's perspective on the perceived fit, relevance, or compatibility of session material to the Veteran's sleep health and life engagement concerns. Items are scored as follows: 1 - completely disagree; 2 - disagree; 3 - neither agree nor disagree; 4 - agree; 5 - completely agree. Total scores are from 4 to 20 with higher scores indicating better appropriateness of the intervention.
Time frame
Endpoint (30 day)Sponsors and contacts
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Source ClinicalTrials.gov