Community Stroke Self-management Program

NCT06251128 | Recruiting

• 1 other identifier: 22-09-5982-A
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Blood Pressure

Keywords

Stroke; Community; Aging; Blood pressure; Self management

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Self-management

EXPERIMENTAL

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

Interventions

Stroke Self management Program BEHAVIORAL

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

Also known as: Behavioral

Self-management

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Low cognition

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

The Hale County extension Office

Greensboro, Alabama, 36744, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mudasir Andrabi, Ph D

  The University of Alabama

  STUDY DIRECTOR

Central Study Contacts

Mudasir Andrabi, Ph D

CONTACT

205) 348-9875; MANDRABI@UA.EDU

Lin Chen, Ph D

CONTACT

clin@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group study

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: February 9, 2024
• Study Start: January 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2 YEARS

Locations

US (1)