Self-Management Program for Stroke

(IPASS-R Trial)

Overseen By Juliana H. Earwood, OTD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Severe depression, Dementia, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help individuals who have recently experienced a stroke manage their recovery more effectively. Delivered through telehealth, participants can join from home. The program focuses on enhancing confidence, daily activities, and overall quality of life. Participants will either engage in a new stroke-specific self-management program called Improving Participation after Stroke Self-Management Program (IPASS) or a general chronic disease management program, both led by professionals and peers. This trial suits those who have had a mild to moderate stroke within the last six months, have completed rehabilitation if needed, and are living at home with or without caregiver support. As an unphased trial, this study provides a unique opportunity to contribute to innovative stroke recovery research from the comfort of home.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this self-management program is safe for stroke patients?

Research has shown that the Improving Participation after Stroke Self-Management Program (IPASS) helps individuals enhance their lives following a stroke. The program aims to build self-confidence and support participation in daily activities. No safety concerns have been reported with this program. Offered through telehealth, IPASS does not involve medications or physical treatments, making medical side effects unlikely. The program focuses on teaching new skills and strategies, ensuring a safe process for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Self-Management Program for Stroke because it offers a new approach to helping stroke survivors regain their independence. Unlike traditional treatments that often focus on medical interventions, the IPASS program emphasizes self-management through a series of interactive, remote sessions led by occupational therapists and peer facilitators who have experienced stroke themselves. This peer support element can enhance motivation and engagement, making the recovery process more relatable and personalized. Additionally, the use of videoconferencing makes the program accessible to a wider audience, removing geographical barriers and allowing participants to engage from the comfort of their homes. Overall, IPASS could revolutionize how we support stroke survivors in their journey toward recovery.

What evidence suggests that the Improving Participation after Stroke Self-Management Program (IPASS) is effective for stroke recovery?

Research has shown that the Improving Participation after Stroke Self-Management Program (IPASS), which participants in this trial may receive, helps stroke survivors manage and engage in daily activities more effectively. One study found that participants felt more confident in handling life after a stroke, demonstrating improved self-efficacy. They also became better at returning to their normal routines, as measured by tools like the Reintegration to Normal Living Index. This suggests that IPASS could positively affect confidence, activity levels, and overall quality of life for people recovering from a stroke. ^{1 2 3 4 6}

Who Is on the Research Team?

Anna E Boone, PhD, OTR/L

Principal Investigator

University of Missouri Occupational Therapy

Are You a Good Fit for This Trial?

This trial is for individuals aged 45-85 who had a mild or moderate stroke within the last 6 months, live in the community (not in skilled nursing facilities), can communicate in English, and can use videoconferencing with or without help. They should have finished any recommended inpatient rehab.

Inclusion Criteria

I live at home, with or without help from a caregiver.

I had a stroke less than 6 months ago.

I can use video calls on my own or with help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the IPASS-R intervention consisting of 6 weekly 90-minute sessions delivered via telehealth

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for self-efficacy, activity performance, and quality of life improvements

26 weeks

1 visit (virtual) at 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Improving Participation after Stroke Self-Management Program (IPASS)

Trial Overview The study tests a telehealth program called IPASS designed specifically for stroke survivors to improve self-confidence, daily activities, and life quality after stroke. It's compared to a general chronic disease program known as CDSMP.

How Is the Trial Designed?

Group I: Improving Participation after Stroke Self-Management Program (IPASS) Experimental Treatment 1 Intervention

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.

Group II: Chronic Disease Self-Management Program (CDSMP) Active Control 1 Intervention

The CDSMP will consist of 6, weekly 90-minute sessions. All sessions will be delivered remotely via videoconferencing.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

A scoping review of 56 articles found that most interventions aimed at improving medication self-management for stroke patients focused on secondary stroke prevention and lifestyle changes, but often did not specifically target medication self-management as a standalone goal.

The majority of these interventions combined face-to-face interactions with technology, highlighting a need for more comprehensive approaches that support medication self-management in community settings and consider optimal delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication self-management interventions for persons with stroke: A scoping review. Cadel, L., Cimino, SR., Bradley-Ridout, G., et al.[2023]

Only 29% of stroke survivors participated in the Chronic Disease Self-Management Program (CDSMP), but participation increased when barriers like transportation and financial issues were addressed.

Factors such as moderate to severe disability and more frequent clinic/home visits were linked to higher attendance in CDSMP sessions, suggesting that tailored support can enhance engagement in self-management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Participation in the Chronic Disease Self-Management Program: Findings From the SUCCEED Trial. Lin, AM., Vickrey, BG., Barry, F., et al.[2022]

The Southampton Stroke Self-Management Questionnaire (SSSMQ) was developed and tested with 87 stroke survivors, showing excellent reliability (Mokken r = 0.89) and test-retest reliability (ICC = 0.928).

Preliminary results indicate that the SSSMQ is a valid tool for measuring self-management competency in stroke patients, making it a promising outcome measure for evaluating self-management interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and psychometric evaluation of a new patient -reported outcome measure for stroke self -management: The Southampton Stroke Self - Management Questionnaire (SSSMQ). Boger, EJ., Hankins, M., Demain, SH., et al.[2022]

The patient-centered self-management empowerment intervention (PCSMEI) significantly improved self-efficacy in first-time stroke survivors at discharge and continued to show benefits one and three months post-discharge, compared to routine care.

Participants in the PCSMEI group also demonstrated better performance in activities of daily living (ADL) at three months post-discharge and had a lower rehospitalization rate, indicating the intervention's potential to enhance recovery and reduce hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Study of Effectiveness of a Patient-Centered Self-Management Empowerment Intervention During Predischarge Planning on Stroke Survivors. Chen, L., Chen, Y., Chen, X., et al.[2022]

The Improving Participation After Stroke Self-management program (IPASS-R) demonstrated positive effects on community integration and perceived recovery in a small group of 17 stroke participants, suggesting it can enhance post-stroke living.

Participants in the intervention group showed significantly greater improvements in their ability to reintegrate into normal living and overall stroke impact compared to the control group, indicating the program's potential effectiveness in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining a participation-focused stroke self-management intervention in a day rehabilitation setting: a quasi-experimental pilot study. Lee, D., Fischer, H., Zera, S., et al.[2018]

A self-management intervention for stroke survivors significantly improved self-efficacy, mental health, and activities of daily living compared to usual care, as shown in a study with 185 participants from three Italian hospitals.

Participants in the intervention group were much more likely to engage with healthcare services and maintain regular exercise after discharge, indicating enhanced self-management skills, especially among those with higher education levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Look After Yourself (LAY) intervention to improve self-management in stroke survivors: Results from a quasi-experimental study. Messina, R., Dallolio, L., Fugazzaro, S., et al.[2021]

The Improving Participation after Stroke Self-Management Program (IPASS) significantly increased self-efficacy in managing chronic health conditions and participating in everyday activities among 185 participants with mild-to-moderate chronic stroke, with moderate effect sizes of 0.46 and 0.55, respectively.

These improvements were observed both immediately after the intervention and were retained at a 6-9 month follow-up, suggesting that IPASS may be an effective approach for enhancing long-term recovery and community reintegration for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of the Improving Participation after Stroke Self-Management Program (IPASS): An Exploratory Randomized Clinical Study. Wolf, TJ., Baum, CM., Lee, D., et al.[2019]

The Improving Participation After Stroke Self-Management program (IPASS) was found to be feasible and effective for an Israeli population, with significant improvements in Functional Independence Measure (FIM) scores for participants who received the intervention compared to those who only received standard care.

Participants in the IPASS group showed moderate to large effect sizes in self-efficacy and reintegration measures, indicating that the program effectively enhances stroke survivors' ability to manage their participation in daily activities and reintegrate into the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the feasibility and effectiveness of a culturally adapted participation-focused stroke self-management program in a day-rehabilitation setting: A randomized pilot study. Harel-Katz, H., Adar, T., Milman, U., et al.[2021]

The meta-review of seven systematic reviews, encompassing 130 unique studies, emphasizes the critical need for tailored self-management support for stroke patients, highlighting the varying needs throughout their recovery journey.

Key themes identified include the importance of psychological support, effective communication with healthcare professionals, and the benefits of goal-setting and social support, which are essential for improving the overall recovery experience for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Self-Management Support Following a Stroke: A Meta-Review of Qualitative Systematic Reviews. Pearce, G., Pinnock, H., Epiphaniou, E., et al.[2022]

The Stroke Self-management Behaviors Performance Scale (SSBPS) was developed and validated with 128 stroke survivors, showing good internal consistency and test-retest reliability, indicating it is a reliable tool for assessing self-management behaviors in stroke recovery.

The SSBPS identified two key factors—'Psychosocial management' and 'Medical management'—which together accounted for 62% of the variance, suggesting that both aspects are crucial for effective self-management in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and psychometric evaluation of a questionnaire for assessing self-management behaviors in stroke survivors. Lo, SHS., Chau, JPC., Choi, KC.[2022]

Self-management programs for stroke survivors show promising results, with significant treatment effects found in six out of nine randomized controlled trials and three out of six non-randomized trials, particularly in improving disability and quality of life.

Four large randomized controlled trials (each with over 100 participants) demonstrated statistically significant benefits for self-management interventions, highlighting the need for further research to refine these programs and determine the best delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management programmes for people post stroke: a systematic review. Lennon, S., McKenna, S., Jones, F.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4929017/

The Development of the Improving Participation after ... The data demonstrate that the IPASS was able to improve the participants' self-efficacy to manage and participate in home, community, and work activities, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06588647

Improving Participation After Stroke Self-Management ... 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 ...

3. archives-pmr.org archives-pmr.org/article/S0003-9993(16)31076-0/fulltext

Improving Participation after Stroke: Examining A ... Primary outcome measures were the Reintegration to Normal Living Index, Stroke Impact Scale, and Participation Strategies Self-Efficacy Scale. Results. Analysis ...

4. ahs.uic.edu ahs.uic.edu/research/improving-participation-after-stroke-self-management-rehabilitation-ipass-r/

Improving Participation After Stroke Self-Management ... The overall goal of this study is to evaluate the efficacy of a small-group, stroke-specific, self-management program delivered via telehealth to improve self- ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27077987/

The Development of the Improving Participation after Stroke ... This study evaluated the Improving Participation after Stroke Self-Management Program (IPASS) to improve self-efficacy and participation in everyday life ...

6. researchgate.net researchgate.net/publication/298654374_The_Development_of_the_Improving_Participation_after_Stroke_Self-Management_Program_IPASS_An_Exploratory_Randomized_Clinical_Study

An Exploratory Randomized Clinical Study | Request PDF This study evaluated the Improving Participation after Stroke Self-Management Program (IPASS) to improve self-efficacy and participation in ...