Community Stroke Self-management Program

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251128
• Other study ID #: 22-09-5982-A
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: University of Alabama, Tuscaloosa
• Contact: Mudasir Andrabi, Ph D
• Phone: 205) 348-9875
• Email: MANDRABI[@]UA.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• History of Stroke

• High blood pressure condition

• African American

• Age 50 and above

Exclusion Criteria:

-Low cognition

Related Conditions & MeSH terms

• Blood Pressure
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	The Hale County extension Office	Greensboro	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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:
Primary	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