SleepI-SLEPTNCT07317336
I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions
A study testing I-SLEPT in people with Sleep and Participation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Sleep is essential to functional recovery in inpatient medical settings; however, sleep is likely to be disrupted during rehabilitation and hospital admissions. Adverse effects of these disruptions do not subside after discharge, leading to additional consequences such as poor physical function. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep, Participation
- What is being tested?
- I-SLEPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2026to 31 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to and discharged from VA Boston acute care units OR Community Living Center subacute rehabilitation unit
- 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
Who cannot join
- Discharged from Long-Term Care, Hospice and Palliative Care, or Spinal Cord Injury bed specialty
- Discharged from intensive care units
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Julia T Boyle, PsyD, (617) 963-6391, julia.boyle@va.gov
Jennifer A Moye, PhD, (774) 826-3721, Jennifer.Moye@va.gov
About this study
Sleep is essential to functional recovery in inpatient medical settings; however, sleep is likely to be disrupted during rehabilitation and hospital 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.
Read the 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 acute hospitalization and/or 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 VA Boston's acute care hospital units or 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.
- Conditions
- Sleep, Participation
- Being tested
- I-SLEPT
- Keywords
- sleep, participation, rehabilitation, transitions of care, physical function, hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-SLEPTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| I-SLEPT | Experimental | 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. Receives: Behavioral: I-SLEPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Endpoint (30 day), 3 Month
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.
Measured: Baseline, Endpoint (30 day), 3 Month
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.
Measured: Endpoint (30 day)
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.
Measured: 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.
Measured: Endpoint (30 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start22 Jun 2026
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Assess for feasibility and clinically significant results of I-SLEPT in a proof-of-concept, single-arm trail in Veterans (Enrollment Target; N = 60) age 50 years and older who were recently discharged from VA Boston Subacute Rehabilitation to home. Targeting 40 completers.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julia T Boyle, PsyD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317336
- Sponsor's protocol ID
- RRD9-010-25M
- Other IDs
- 1IK2RD000347-01A1
- Acronym
- I-SLEPT
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions
- ClinicalTrials.gov ID
- NCT07317336
- Acronym / sponsor ID
- I-SLEPT / RRD9-010-25M
- Conditions
- Sleep, Participation
- Keywords
- sleep, participation, rehabilitation, transitions of care, physical function, hospitalization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep is essential to functional recovery in inpatient medical settings; however, sleep is likely to be disrupted during rehabilitation and hospital 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 acute hospitalization and/or 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 VA Boston's acute care hospital units or 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assess for feasibility and clinically significant results of I-SLEPT in a proof-of-concept, single-arm trail in Veterans (Enrollment Target; N = 60) age 50 years and older who were recently discharged from VA Boston Subacute Rehabilitation to home. Targeting 40 completers.
| Arm | Type | Receives |
|---|---|---|
| I-SLEPT | Experimental | Behavioral: I-SLEPTVeterans 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted to and discharged from VA Boston acute care units OR Community Living Center subacute rehabilitation unit
- 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)
Key exclusion criteria (6 listed)
- Discharged from Long-Term Care, Hospice and Palliative Care, or Spinal Cord Injury bed specialty
- Discharged from intensive care units
- 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
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 |
|---|---|---|
| I-SLEPTVeterans 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. | Behavioural | I-SLEPT |
Primary outcome
RuSATED
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).
What Matters Most (WMM) Tool
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.
Acceptability of Intervention Measure (AIM)
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.
Feasibility of Intervention Measure (FIM)
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.
1 secondary outcome
Intervention Appropriateness Measure (IAM)
Time frame: Endpoint (30 day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Julia T Boyle, PsyD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-SLEPT in people with Sleep and Participation, 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia T Boyle, PsyD ((617) 963-6391, julia.boyle@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RuSATED (time frame: Baseline, Endpoint (30 day), 3 Month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.