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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Improving Participation after Stroke Self-Management Program (IPASS)?

Research shows that self-management programs can improve quality of life and self-confidence in managing health for stroke survivors. The IPASS program specifically aims to enhance participation in daily activities, which is crucial for long-term recovery and community reintegration after a stroke. ^{1 2 3 4 5}

Is the Self-Management Program for Stroke safe for humans?

The available research does not specifically address the safety of the Self-Management Program for Stroke, but self-management programs in general are designed to support stroke survivors in managing their health and medications, which suggests they are generally safe and focused on improving quality of life. ^{1 3 6 7 8}

How is the IPASS treatment different from other stroke treatments?

The IPASS treatment is unique because it focuses on improving participation in everyday life activities and community reintegration for stroke survivors, rather than just managing symptoms. It is a self-management program that enhances self-efficacy (confidence in managing one's condition) and is delivered in a group setting led by an occupational therapist and a lay person with stroke experience. ^{1 5 9 10 11}

Research Team

Anna E Boone, PhD, OTR/L

Principal Investigator

University of Missouri Occupational Therapy

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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]

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]

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]

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) 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Participation in the Chronic Disease Self-Management Program: Findings From the SUCCEED Trial. [2022]

2. England 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). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Development and psychometric evaluation of a questionnaire for assessing self-management behaviors in stroke survivors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Longitudinal Study of Effectiveness of a Patient-Centered Self-Management Empowerment Intervention During Predischarge Planning on Stroke Survivors. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Development of the Improving Participation after Stroke Self-Management Program (IPASS): An Exploratory Randomized Clinical Study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Medication self-management interventions for persons with stroke: A scoping review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Experiences of Self-Management Support Following a Stroke: A Meta-Review of Qualitative Systematic Reviews. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

The Look After Yourself (LAY) intervention to improve self-management in stroke survivors: Results from a quasi-experimental study. [2021]

9. England 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Examining a participation-focused stroke self-management intervention in a day rehabilitation setting: a quasi-experimental pilot study. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Self-management programmes for people post stroke: a systematic review. [2018]