StrokeIPASS-RNCT06588647
Improving Participation After Stroke Self-Management-Rehabilitation
A study testing Improving Participation after Stroke Self-Management Program (IPASS) and Chronic Disease Self-Management Program (CDSMP) in people with Stroke, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The overall goal of this proposed study is to evaluate the efficacy of a small-group, stroke-specific, self-management program delivered via telehealth to improve self-efficacy, activity performance, and quality of life in individuals with sub-acute stroke. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Improving Participation after Stroke Self-Management Program (IPASS) and Chronic Disease Self-Management Program (CDSMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to 15 Dec 2029
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- less than 6 months post-stroke
- age 45-85 years
- completed inpatient rehabilitation services (if recommended)
- living in the community with or without caregiver support (i.e., not living in a skilled nursing facility)
- ability to read, write, and speak English
- diagnosis of mild or moderate stroke (National Institutes of Health stroke score <16)
- able to use videoconferencing independently or with caregiver support
Who cannot join
- severe depressive symptoms as indicated by a score ≥21 on the Patient Health Questionnaire
- dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment
- additional neurological diagnoses (e.g., brain malignancy, previous severe stroke)
- (4) moderate or severe aphasia as indicated by a National Institutes of Health Stroke Scale aphasia score of ≥ 2
- inability to provide informed consent
- any other condition not otherwise specified that the PI determines would render participation in this study as unsafe for the participant
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
University of Missouri
Columbia, Missouri, 65211
Juliana Earwood, OTD, 573-884-6681, jmhudson@health.missouri.edu
Anna Boone, PhD
About this study
Official title: Efficacy of the Improving Participation After Stroke Self-Management-Rehabilitation (IPASS-R) Program in Sub-acute Stroke
The overall goal of this proposed study is to evaluate the efficacy of a small-group, stroke-specific, self-management program delivered via telehealth to improve self-efficacy, activity performance, and quality of life in individuals with sub-acute stroke.
- Conditions
- Stroke
- Being tested
- Improving Participation after Stroke Self-Management Program (IPASS), Chronic Disease Self-Management Program (CDSMP)
- Keywords
- Stroke, Self-Management, Telehealth, Activities of daily living, Community engagement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving Participation after Stroke Self-Management Program (IPASS)Behavioural
The IPASS-R program is a group-based self-management intervention that aims to improve problem-solving, action-planning, and resource utilization skills for improved community living and participation. The Activity-Barriers-Changes-Doing-Evaluation (ABCDE) framework is a user friendly problem-solving and goal setting framework that is used repetitively in each session throughout the program. Participants are guided to identify (1) an activity that they want to improve or re-engage in (A); (2) individual and environmental barriers that hinder their engagement (B); (3) changes that they can make to deal with the barriers and improve their engagement (C); and (4) an action plan to pursue (D). After the action plan, participants come back in the next session and evaluate their performance in following through on their plans (E).
Chronic Disease Self-Management Program (CDSMP)Behavioural
The program is facilitated by two trained leaders in small groups in a community setting with individuals who have chronic health problems and will follow the CDSMP protocol. Participants receive education on various health-related topics applicable to a range of chronic conditions, share experiences, and support one another.
| Study group | Role | What they receive |
|---|---|---|
| Improving Participation after Stroke Self-Management Program (IPASS) | Experimental | The IPASS-R intervention consists of 6 weekly 90-minute sessions delivered by an occupational therapist and stroke survivor peer facilitator. All sessions will be delivered remotely via videoconferencing. Receives: Behavioral: Improving Participation after Stroke Self-Management Program (IPASS) |
| Chronic Disease Self-Management Program (CDSMP) | Active comparator | The CDSMP will consist of 6, weekly 90-minute sessions. All sessions will be delivered remotely via videoconferencing. Receives: Behavioral: Chronic Disease Self-Management Program (CDSMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM) Performance
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Measured: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Canadian Occupational Performance Measure (COPM) Satisfaction
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Measured: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Participation Strategies Self-Efficacy Scale (PS-SES)
Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources. Range of scores from 35-350. Higher scores indicate greater self-efficacy.
Measured: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Secondary outcomes (4)
In home activity level as measured by sensor system
average hourly percentage of time spent engaged in activity
Measured: Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)
Community engagement as measured by sensor system
Time outside the home as measured by time between door sensor activations
Measured: Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)
Stroke Impact Scale participation domain
Measures perceived stroke recovery/quality of life. Range of scores 0-100. Higher scores indicate higher performance.
Measured: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Assessment of Life Habits (LIFE-H)
Measures self-reported participation in daily activities by measuring total score across 6 domains. Score range of 0 to 9 with higher scores indicating better performance.
Measured: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Dec 2024
- Primary completion15 Dec 2029 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Illinois Chicago
- Responsible party
- Principal investigator, Anna Boone, University of Missouri-Columbia
- Investigators
- Anna E Boone, PhD, OTR/L, Principal investigator, University of Missouri Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588647
- Sponsor's protocol ID
- 2108606
- Other IDs
- 1R01HD114732-01
- Acronym
- IPASS-R
- Status last verified
- Apr 2026
- First submitted
- 6 Sep 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jette DU, Latham NK, Smout RJ, Gassaway J, Slavin MD, Horn SD. Physical therapy interventions for patients with stroke in inpatient rehabilitation facilities. Phys Ther. 2005 Mar;85(3):238-48.
PubMed 15733048Sakakibara BM, Kim AJ, Eng JJ. A Systematic Review and Meta-Analysis on Self-Management for Improving Risk Factor Control in Stroke Patients. Int J Behav Med. 2017 Feb;24(1):42-53. doi: 10.1007/s12529-016-9582-7.
PubMed 27469998Fryer CE, Luker JA, McDonnell MN, Hillier SL. Self management programmes for quality of life in people with stroke. Cochrane Database Syst Rev. 2016 Aug 22;2016(8):CD010442. doi: 10.1002/14651858.CD010442.pub2.
PubMed 27545611Chen L, Chen Y, Chen X, Shen X, Wang Q, Sun C. Longitudinal Study of Effectiveness of a Patient-Centered Self-Management Empowerment Intervention During Predischarge Planning on Stroke Survivors. Worldviews Evid Based Nurs. 2018 Jun;15(3):197-205. doi: 10.1111/wvn.12295.
PubMed 29878691Cadilhac DA, Hoffmann S, Kilkenny M, Lindley R, Lalor E, Osborne RH, Batterbsy M. A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program. Stroke. 2011 Jun;42(6):1673-9. doi: 10.1161/STROKEAHA.110.601997. Epub 2011 Apr 14.
PubMed 21493910Wolf TJ, Baum CM, Lee D, Hammel J. The Development of the Improving Participation after Stroke Self-Management Program (IPASS): An Exploratory Randomized Clinical Study. Top Stroke Rehabil. 2016 Aug;23(4):284-92. doi: 10.1080/10749357.2016.1155278. Epub 2016 Mar 16.
PubMed 27077987Lee D, Fischer H, Zera S, Robertson R, Hammel J. Examining a participation-focused stroke self-management intervention in a day rehabilitation setting: a quasi-experimental pilot study. Top Stroke Rehabil. 2017 Dec;24(8):601-607. doi: 10.1080/10749357.2017.1375222. Epub 2017 Sep 28.
PubMed 28956721
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Improving Participation After Stroke Self-Management-Rehabilitation (IPASS-R) Program in Sub-acute Stroke
- ClinicalTrials.gov ID
- NCT06588647
- Acronym / sponsor ID
- IPASS-R / 2108606
- Conditions
- Stroke
- Keywords
- Stroke, Self-Management, Telehealth, Activities of daily living, Community engagement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- University of Washington, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Illinois Chicago
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 15 Dec 2029 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 19 Sep 2024 (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.
The overall goal of this proposed study is to evaluate the efficacy of a small-group, stroke-specific, self-management program delivered via telehealth to improve self-efficacy, activity performance, and quality of life in individuals with sub-acute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improving Participation after Stroke Self-Management Program (IPASS) | Experimental | Behavioral: Improving Participation after Stroke Self-Management Program (IPASS)The IPASS-R intervention consists of 6 weekly 90-minute sessions delivered by an occupational therapist and stroke survivor peer facilitator. All sessions will be delivered remotely via videoconferencing. |
| Chronic Disease Self-Management Program (CDSMP) | Active comparator | Behavioral: Chronic Disease Self-Management Program (CDSMP)The CDSMP will consist of 6, weekly 90-minute sessions. All sessions will be delivered remotely via videoconferencing. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- less than 6 months post-stroke
- age 45-85 years
- completed inpatient rehabilitation services (if recommended)
- living in the community with or without caregiver support (i.e., not living in a skilled nursing facility)
- ability to read, write, and speak English
Key exclusion criteria (6 listed)
- severe depressive symptoms as indicated by a score ≥21 on the Patient Health Questionnaire
- dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment
- additional neurological diagnoses (e.g., brain malignancy, previous severe stroke)
- (4) moderate or severe aphasia as indicated by a National Institutes of Health Stroke Scale aphasia score of ≥ 2
- inability to provide informed consent
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 |
|---|---|---|
| Improving Participation after Stroke Self-Management Program (IPASS)The IPASS-R program is a group-based self-management intervention that aims to improve problem-solving, action-planning, and resource utilization skills for improved community living and participation. The Activity-Barriers-Changes-Doing-Evaluation (ABCDE) framework is a user friendly problem-solving and goal setting framework that is used repetitively in each session throughout the program. Participants are guided to identify (1) an activity that they want to improve or re-engage in (A); (2) individual and environmental barriers that hinder their engagement (B); (3) changes that they can make to deal with the barriers and improve their engagement (C); and (4) an action plan to pursue (D). After the action plan, participants come back in the next session and evaluate their performance in following through on their plans (E). | Behavioural | Improving Participation after Stroke Self-Management Program (IPASS) |
| Chronic Disease Self-Management Program (CDSMP)The program is facilitated by two trained leaders in small groups in a community setting with individuals who have chronic health problems and will follow the CDSMP protocol. Participants receive education on various health-related topics applicable to a range of chronic conditions, share experiences, and support one another. | Behavioural | Chronic Disease Self-Management Program (CDSMP) |
Primary outcome
Canadian Occupational Performance Measure (COPM) Performance
Time frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Canadian Occupational Performance Measure (COPM) Satisfaction
Time frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Participation Strategies Self-Efficacy Scale (PS-SES)
Time frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources. Range of scores from 35-350. Higher scores indicate greater self-efficacy.
4 secondary outcomes
In home activity level as measured by sensor system
Time frame: Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)
Community engagement as measured by sensor system
Time frame: Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)
Stroke Impact Scale participation domain
Time frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Assessment of Life Habits (LIFE-H)
Time frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
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 28 Apr 2026.
- Background: PubMed 15733048Jette DU, Latham NK, Smout RJ, Gassaway J, Slavin MD, Horn SD. Physical therapy interventions for patients with stroke in inpatient rehabilitation facilities. Phys Ther. 2005 Mar;85(3):238-48.
- Background: PubMed 27469998Sakakibara BM, Kim AJ, Eng JJ. A Systematic Review and Meta-Analysis on Self-Management for Improving Risk Factor Control in Stroke Patients. Int J Behav Med. 2017 Feb;24(1):42-53. doi: 10.1007/s12529-016-9582-7.
- Background: PubMed 27545611Fryer CE, Luker JA, McDonnell MN, Hillier SL. Self management programmes for quality of life in people with stroke. Cochrane Database Syst Rev. 2016 Aug 22;2016(8):CD010442. doi: 10.1002/14651858.CD010442.pub2.
- Background: PubMed 29878691Chen L, Chen Y, Chen X, Shen X, Wang Q, Sun C. Longitudinal Study of Effectiveness of a Patient-Centered Self-Management Empowerment Intervention During Predischarge Planning on Stroke Survivors. Worldviews Evid Based Nurs. 2018 Jun;15(3):197-205. doi: 10.1111/wvn.12295.
- Background: PubMed 21493910Cadilhac DA, Hoffmann S, Kilkenny M, Lindley R, Lalor E, Osborne RH, Batterbsy M. A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program. Stroke. 2011 Jun;42(6):1673-9. doi: 10.1161/STROKEAHA.110.601997. Epub 2011 Apr 14.
- Background: PubMed 27077987Wolf TJ, Baum CM, Lee D, Hammel J. The Development of the Improving Participation after Stroke Self-Management Program (IPASS): An Exploratory Randomized Clinical Study. Top Stroke Rehabil. 2016 Aug;23(4):284-92. doi: 10.1080/10749357.2016.1155278. Epub 2016 Mar 16.
- Background: PubMed 28956721Lee D, Fischer H, Zera S, Robertson R, Hammel J. Examining a participation-focused stroke self-management intervention in a day rehabilitation setting: a quasi-experimental pilot study. Top Stroke Rehabil. 2017 Dec;24(8):601-607. doi: 10.1080/10749357.2017.1375222. Epub 2017 Sep 28.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Anna E Boone, PhD, OTR/L principal investigator
University of Missouri Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving Participation after Stroke Self-Management Program (IPASS) and Chronic Disease Self-Management Program (CDSMP) in people with Stroke, run by University of Missouri-Columbia 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 7 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 28 Apr 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 Anna E Boone, PhD, OTR/L (5738827023, booneae@umsystem.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) Performance (time frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06588647, which also lists 7 linked publications.
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 28 Apr 2026.