Community Stroke Self-management Program

Community Stroke Self-management Program for Rural Dwelling African American Stroke Survivors

This pilot project aims develop a need-based community stroke self-management program that would improve the stroke self-management self-efficacy and competencies among African American stroke survivors living in rural Alabama. This study is a mixed-methods study to collect data related to the needs of these individuals and develop a need-based intervention based on the actual needs/ preferences of our target population. The specific aims are to assess the needs, access barriers, existing resources for a stroke self-management program; and develop a Community Stroke Self-management Program for improving stroke survivors' abilities to manage their medication adherence, diet, Physical Activity (PA) requirements, symptoms, and psychological distress to better meet their needs, expectations, and preferences. Another aim is to examine the feasibility and acceptability of delivering the CSSP after tailoring the proposed intervention in Aim 2a) among the AA chronic stroke survivors living in rural Alabama.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Blood Pressure
• Intervention / Treatment: Behavioral: Stroke Self management Program

Detailed Description

Stroke is a leading cause of mortality and morbidity. African American (AA) populations have a higher prevalence of stroke than whites do. The lack of resources leads to substantial physical, social, and psychological burdens and makes self-management more challenging, hence putting these individuals at high risk for secondary chronic conditions. This is especially prominent among underserved populations including AA living in the black belt of rural Alabama due to the additional factors related to their socio-demographic characteristics. This pilot project aims develop a need-based community stroke self-management program that would improve the stroke self-management self-efficacy and competencies among African American stroke survivors living in rural Alabama. This is a mixed-methods study to collect data related to the needs of these individuals and develop a need-based intervention based on the actual needs/ preferences of the target population. The specific aims are to assess the needs, access barriers, existing resources for a stroke self-management program; and develop a Community Stroke Self-management Program for improving stroke survivors' abilities to manage their medication adherence, diet, Physical Activity (PA) requirements, symptoms, and psychological distress to better meet their needs, expectations, and preferences. The study also aim to examine the feasibility and acceptability of delivering the CSSP after tailoring our proposed intervention in Aim 2a) among the AA chronic stroke survivors living in rural Alabama. Conducting this study would help to have a sustainable intervention with minimal need of healthcare workers for its online delivery, potentially it would have high scalability and a high economic impact in the long run. Therefore, this project is vital for meeting the unique needs of this underserved population.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mudasir Andrabi, Ph D; Phone Number: 205) 348-9875; Email: MANDRABI@UA.EDU
• Study Contact Backup: Name: Lin Chen, Ph D; Email: clin@uabmc.edu

Study Locations

• United States
  • Alabama
    • Greensboro, Alabama, United States, 36744
      • Recruiting
      • The Hale County extension Office
      • Contact: Jovita Lewis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of Stroke
• High blood pressure condition
• African American
• Age 50 and above

Exclusion Criteria:

-Low cognition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-management; This group of participants will be given education and will be taught about overcoming the barriers to a healthy lifestyle and medication adherence. No drugs or devices will be administered to the participants/	Behavioral: Stroke Self management Program; Our educational and behavioral program includes an educational component, problem-solving to overcome barriers to a healthy lifestyle, activities of daily living, and management of medications. No drugs or devices will be delivered to the participants; Other Names: Behavioral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Southampton Score Self Management Questionnaire	Questionnaire; Each item on the Southampton Score Self-Management Questionnaire has a minimum score of 1 and a maximum score of 6. A higher score means better Self-management competency following a Stroke. The mean of the scores on this questionnaire will be computed for reporting overall scores on this measure.	3 months
Hypertension Self-care Activity Level Effects	Questionnaire; Each item on self-care activity for management of Hypertension has a minimum score of 0 and a maximum score of 7. A higher score means a better Hypertension Self-care Activity Level. The mean of the scores on this questionnaire will be computed for reporting overall scores on this measure.	3 months:
Hypertension Knowledge Level Scale Test	Questionnaire; Each item on the Hypertension Knowledge Level Scale has a minimum score of 1 and a maximum score of 5. Higher scores on this scale mean a better Hypertension Knowledge Level. The mean of the scores on this questionnaire will be computed for reporting overall scores on this measure.	3 months

Collaborators and Investigators

• Sponsor: University of Alabama, Tuscaloosa
• Collaborators: University of Alabama at Birmingham
• Investigators: Study Director: Mudasir Andrabi, Ph D, The University of Alabama

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Aging; Blood pressure; Community; Self management
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 22-09-5982-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be de-identified and uploaded to the NIA data sharing repository on a quarterly basis. Data to be shared includes the self-reported data on questionnaires including demographic questionnaire, Stroke self-management competencies questionnaire, data collection from blood pressure knowledge questionnaire and medication adherence. All this data will be shared via excel data files, and the results from all clinical evaluations will be shared. Excel software and Microsoft word software will be needed to share and view these data files.
• IPD Sharing Time Frame: 2 YEARS
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No