I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: I-SLEPT.
- Who it may be relevant to
- Registry conditions: Sleep, Participation. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This project will create I-SLEPT (Integrated Sleep and Life Engagement Program for Transitions), a novel intervention to enhance sleep health and life engagement during the transition period following discharge from VA subacute rehabilitation. The development of I-SLEPT will be informed by both Veterans and experts. Including the Veteran perspective is essential to reflect Veterans' choice, ensure access to timely care, and prioritize effective care solutions to improve Veterans' health and well-being. Veterans are more likely to report poor sleep and medical complexities than non-Veterans which may further complicate their readjustment to their home environment after discharge. The proposed study is a single arm clinical trial. Veterans aged 50+ discharged home from the subacute rehabilitation units at VA Boston's Community Living Center will be recruited to complete surveys and interviews informing I-SLEPT creation (Aim 1; N=20), complete a preliminary trial (Aim 2; N=5) or complete a single-arm Proof-of-Concept trial (Aim 3; N=40). Veterans participating in Aims 2 or 3 will complete assessments of sleep health and life engagement, as well as acceptability measures. Results may also inform future work adapting this intervention to other transitional phases (e.g., discharge from acute hospitalization), support Veterans across the lifespan, and support intervention implementation by staff from multiple disciplines and specialties, including nursing, social work, physical therapy, occupational therapy, and Veteran peer specialists.
Interventions
- Behavioral I-SLEPT
Veterans 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.
Primary outcome measures
- RuSATED [Time frame: Baseline, Endpoint (30 day), 3 Month]
- What Matters Most (WMM) Tool [Time frame: Baseline, Endpoint (30 day), 3 Month]
- Acceptability of Intervention Measure (AIM) [Time frame: Endpoint (30 day)]
- Feasibility of Intervention Measure (FIM) [Time frame: Endpoint (30 day)]
Secondary outcome measures (1)
- Intervention Appropriateness Measure (IAM) [Time frame: Endpoint (30 day)]
Eligibility criteria
Inclusion criteria
- 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
- Obtains a score >= 8 on the Brief Interview for Mental Status (BIMS)
- Endorses at least 2 items as "Rarely/Never" or "Sometimes" on the RuSATED measure AND/OR endorses they are achieving their goals at a "much worse" or "a little worse" level on the What Matters Most Tool.
Exclusion criteria
- 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
- High acute risk for suicide
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston
Identifiers
NCT: NCT07317336 · RRD9-010-25M · 1IK2RD000347-01A1