I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• RuSATED [Срок оценки: Baseline, Endpoint (30 day), 3 Month]
• What Matters Most (WMM) Tool [Срок оценки: Baseline, Endpoint (30 day), 3 Month]
• Acceptability of Intervention Measure (AIM) [Срок оценки: Endpoint (30 day)]
• Feasibility of Intervention Measure (FIM) [Срок оценки: Endpoint (30 day)]

Вторичные конечные точки (1)

• Intervention Appropriateness Measure (IAM) [Срок оценки: Endpoint (30 day)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston

Идентификаторы

NCT: NCT07317336 · RRD9-010-25M · 1IK2RD000347-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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