StrokeNCT06251128
Community Stroke Self-management Program
A study testing Stroke Self management Program in people with Stroke and Blood Pressure, run by University of Alabama, Tuscaloosa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Blood Pressure
- What is being tested?
- Stroke Self management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of Stroke
- High blood pressure condition
- African American
- Age 50 and above
Who cannot join
- -Low cognition
Trial locations and contacts
1 site in 1 country.
Lin Chen, Ph D contact
United States1 site, 1 recruiting
- Recruiting
The Hale County extension Office
Greensboro, Alabama, 36744
Jovita Lewis
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Blood Pressure
- Being tested
- Stroke Self management Program
- Keywords
- Stroke, Community, Aging, Blood pressure, Self management
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke Self management ProgramBehavioural
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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/ Receives: Behavioral: Stroke Self management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Mudasir Andrabi, Ph D, Study director, The University of Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251128
- Sponsor's protocol ID
- 22-09-5982-A
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Stroke Self-management Program for Rural Dwelling African American Stroke Survivors
- ClinicalTrials.gov ID
- NCT06251128
- Acronym / sponsor ID
- 22-09-5982-A
- Conditions
- Stroke, Blood Pressure
- Keywords
- Stroke, Community, Aging, Blood pressure, Self management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group study
| Arm | Type | Receives |
|---|---|---|
| Self-management | Experimental | Behavioral: Stroke Self management ProgramThis 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/ |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of Stroke
- High blood pressure condition
- African American
- Age 50 and above
Key exclusion criteria (1 listed)
- -Low cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroke Self management ProgramAlso: BehavioralOur 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 | Behavioural | Self-management |
Primary outcome
Southampton Score Self Management Questionnaire
Time frame: 3 months
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.
Hypertension Self-care Activity Level Effects
Time frame: 3 months:
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.
Hypertension Knowledge Level Scale Test
Time frame: 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Chen, Ph D contact
Mudasir Andrabi, Ph D study director
The University of Alabama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke Self management Program in people with Stroke and Blood Pressure, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mudasir Andrabi, Ph D (205) 348-9875, MANDRABI@UA.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Southampton Score Self Management Questionnaire (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.