- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05350488
Qualitative Analysis of the Post-Stroke Continuum Among African Stroke Survivors in Alabama
July 17, 2023 updated by: Danny Lee, University of Alabama at Birmingham
This proposal seeks to improve the investigators' post-stroke TOC process through developing an innovative, patient informed and guided solution aimed at addressing the investigators' deep south African American population within the UAB system.
The investigators will engage participants in both urban and rural Alabama through informational interviews and work to find common themes to address so that future interventions are useful to their unique needs and desires.
This goes beyond simply identifying barriers and endeavors to discovering solutions.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amber N Clark, MD
- Phone Number: 205-934-8526
- Email: amberclark@uabmc.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
We will screen 60-100 individuals with the goal of enrolling a total of 20 AA stroke survivors +/- their identified caregivers.
Individuals will be recruited from within the UAB Health System from the acute care neurology stroke service and the PI's stroke recovery clinic.
Participants will be separated into 3 groups.
Group A will include n=10 participants that are less than 1 year out from their most recent stroke.
Group B will include n=10 participants that are greater than 1 year out from their most recent stroke.
Group C will include the participants' identified caregivers.
Having an available caregiver is preferred but is not required.
Therefore, a goal of at least 10 caregivers is set.
Description
Inclusion Criteria:
- African American
- Aged 40 years and older
- Required home health therapy, outpatient therapy, skilled nursing facility or inpatient rehabilitation
- Alabama Resident
- Fluent in English
- Stroke confirmed by advanced imaging (CT, MRI)
- Zoom capability (participants can either have video conference ability or can call into Zoom line)
- Caregivers must be identified by patients as providing a significant portion of care and/or be able to articulate their role as a caregiver
Exclusion Criteria:
- Did not require home health therapy, outpatient therapy or inpatient rehabilitation
- Long term residents of skilled nursing facility
- Severe aphasia
- Severe cognitive impairments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stroke Survivors <1 year
Group A will include participants that are less than 1 year out from their most recent stroke.
|
Interview topics will fall in the broad categories of assessing medical knowledge and understanding of stroke, knowledge of medical and community resources, understanding and experience of post-stroke rehabilitation barriers faced upon reintegrating back home and ability to continue management of stroke diagnosis and suggestions for improvement.
|
Stroke Survivors >1 year
Group B will include participants that are greater than 1 year out from their most recent
|
Interview topics will fall in the broad categories of assessing medical knowledge and understanding of stroke, knowledge of medical and community resources, understanding and experience of post-stroke rehabilitation barriers faced upon reintegrating back home and ability to continue management of stroke diagnosis and suggestions for improvement.
|
Caregivers
Group C will include participants' identified caregivers.
|
Focus group topics will fall into the same broad categories as the informational interviews, however will be asked from a caregiver's perspective
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruitment and retention
Time Frame: July 1,2022-January 20, 2023
|
The investigators will screen 60-100 individuals with the goal of enrolling a total of 20 AA (African American) stroke survivors +/- their identified caregivers.
Historically, there has been low recruitment and retention rates for AAs.
The investigators plan to over-recruit in order to account for this phenomenon and track our success/failure rates with percent retained vs recruited.
|
July 1,2022-January 20, 2023
|
Ability to use Zoom platform
Time Frame: July 1,2022-January 20, 2023
|
The Zoom platform is becoming a more popular avenue to conduct qualitative interviews for research purposes among researchers and participants.
The investigators will evaluate if this reported phenomenon is reproducible within this particular research cohort.
Success will measured by a 50% or greater completion of interview and the ability to successfully connect to the zoom platform either via smart device or telephone dial in.
The investigators will also document any technical difficulties that are encountered from either the interviewer's standpoint or the participant's standpoint.
|
July 1,2022-January 20, 2023
|
Validity of questions asked to arrive at the themes that will appropriately inform the basis of this proposal
Time Frame: February 2023-May 2023
|
We will extract data from transcriptions of participants' Zoom interviews and perform thematic analysis
|
February 2023-May 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2023
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
March 30, 2022
First Submitted That Met QC Criteria
April 21, 2022
First Posted (Actual)
April 28, 2022
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300009035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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