NCT Number: NCT07317336
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02130-4817, United States
Location status: Recruiting
Jennifer A Moye, PhD
CONTACT
Julia T Boyle, PsyD
CONTACT
Julia T Boyle, PsyD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, Endpoint (30 day), 3 Month
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 Month
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: Endpoint (30 day)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
Jennifer A Moye, PhD
CONTACT
Julia T Boyle, PsyD
CONTACT
VA Office of Research and Development
Fed
Acronym: I-SLEPT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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