I-MAS for Stroke Survivors

(I-MAS Trial)

Overseen By Hend Mansoor, PharmD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hend Mansoor

Must be taking: Secondary preventatives

Disqualifiers: Aphasia, Cognitive impairment, Terminal illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help stroke survivors manage high blood pressure more effectively through a new program called I-MAS. Community health workers and pharmacists lead educational sessions, emphasizing the importance of taking medication correctly and overcoming related obstacles. The program targets individuals who have experienced an ischemic stroke or mini-stroke in the past two years and reside in rural Kentucky. Participants should not have severe speech problems or other major health issues that would hinder participation. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that could enhance stroke recovery programs.

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

The trial does not specify if you need to stop taking your current medications. It focuses on improving how you take your existing medications, so it's likely you will continue them.

What prior data suggests that this intervention is safe for stroke survivors?

Research shows that the I-MAS program helps stroke survivors manage their health more effectively, particularly in medication adherence. The program offers educational sessions and personalized plans to address medication routine issues.

Previous studies on similar programs for stroke survivors have shown positive results. Task-specific exercises tailored to individual needs generally lead to good recovery and outcomes, indicating that participants receive such programs well. Although specific safety data for I-MAS isn't detailed in the sources, the focus on education and personalized support suggests a low risk of negative effects.

By improving medication adherence and overall stroke recovery, I-MAS aims to support and enhance well-being without introducing new medical risks. Participants can expect a supportive approach to their recovery journey. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-MAS program for stroke survivors because it offers a fresh approach by focusing on self-management and medication adherence. Unlike traditional treatments that primarily center on physical rehabilitation and medication, I-MAS combines an educational session with a personalized session tailored to each individual's needs. This unique approach aims to empower stroke survivors to take control of their recovery process, potentially leading to better long-term outcomes and improved quality of life. By prioritizing education and customization, I-MAS addresses the often-overlooked aspect of patient engagement and adherence, which are critical for effective stroke management.

What evidence suggests that this intervention is effective for improving hypertension and stroke outcomes?

Research has shown that self-management programs can help people who have had a stroke. These programs boost confidence in managing health, leading to better physical abilities and emotional well-being. They also aid in controlling high blood pressure, crucial for stroke survivors. Overall, this suggests that the I-MAS program, which participants in this trial will receive, could assist stroke survivors in managing their medication and improving their long-term health. ^{6 7 8 9 10}

Who Is on the Research Team?

Hend Mansoor, PharmD, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for ischemic stroke survivors in rural Kentucky who struggle with taking their blood pressure medications correctly. It's designed to help them understand and manage their treatment better.

Inclusion Criteria

Residing in a rural county in Kentucky

I had a stroke or a mini-stroke in the last 2 years.

Exclusion Criteria

Significant aphasia

Cognitive impairment

Terminal illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a self-management program including an educational session and individually-tailored sessions to improve medication adherence

3 months

Follow-up

Participants are monitored for changes in medication adherence and long-term stroke outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• I-MAS

Trial Overview The I-MAS program, which includes education on managing hypertension and personalized support from health workers to overcome barriers to medication adherence, is being tested.

How Is the Trial Designed?

Group I: Stroke Survivors Experimental Treatment 1 Intervention

self-management program with an an educational session and an individually-tailored session on medication adherence.

Who Is Running the Clinical Trial?

Hend Mansoor

Lead Sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11899324/

Effects of a Self-Management Program on Adults with Stroke Conclusions: The results suggest that the program may enhance self-efficacy, physical function, and emotional well-being in stroke survivors, ...

2. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-022-02876-y

Investigating the effect of self-management program on ... The purpose of this study is to evaluate the effect of a self-management program on the self-efficacy of patients with Stroke.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8198104/

Self-Management in Stroke Survivors - PubMed Central - NIH This report aims to describe timing, contents, and setting of delivery of a patient-centered, self-management program for stroke survivors in their early ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525000692

Efficacy of Home-Based Physical Exercise in Stroke ... This review included randomized controlled trials (RCTs) assessing the effectiveness of home-based rehabilitation under professional supervision ...

5. rehab.jmir.org rehab.jmir.org/2024/1/e50863/

A Digital Intervention to Promote Self-Management Self ... A systematic review of 22 studies (N=1761) investigated the influence of interventions supporting self-management skills on poststroke outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02320994

NCT02320994 | Managing Aftercare for Stroke (MAS): MAS-I The ultimate aim of the complete MAS project (MAS I, II & III) is the development of a model of stroke aftercare delivery that can be evaluated to estimate ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11283334/

Predictive Validity of Motor Assessment Scale on ... The results show that the higher the MAS score, the higher are the odds of being discharged home (OR 1.14, 95% CI 1.04–1.25).

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.117.018827

Efficacy and Safety of Individualized Coaching After Stroke Task-oriented and intensive exercise in the acute and subacute phases after stroke has been shown to give optimal recovery and a good prognosis ...

9. neurocure.de neurocure.de/clinical-center/clinical-studies/completed-studies/mas-i-study-managing-aftercare-for-stroke-a-longitudinal-complex-intervention.html

MAS-I: Managing Aftercare for Stroke MAS-I: Managing Aftercare for Stroke - A longitudinal, complex, interventional study in post-rehabilitation stroke patients.

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31008354/

Identifying unmet needs in long-term stroke care using in- ... Identifying unmet needs in long-term stroke care using in-depth assessment and the Post-Stroke Checklist - The Managing Aftercare for Stroke (MAS-I) study.