StrokeNCT05350488
Qualitative Analysis of the Post-Stroke Continuum Among African Stroke Survivors in Alabama
An observational study of Stroke and Disability Physical, run by University of Alabama at Birmingham.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Disability Physical, Patient Satisfaction
- What is being tested?
- Informational Interview and Focus Group
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 28 Feb 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Did not require home health therapy, outpatient therapy or inpatient rehabilitation
- Long term residents of skilled nursing facility
- Severe aphasia
- Severe cognitive impairments
About this study
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.
- Conditions
- Stroke, Disability Physical, Patient Satisfaction, Caregiver Burden
- Being tested
- Informational Interview, Focus Group
- Keywords
- Rehabilitation, Post-Stroke Rehabilitation Continuum
- Medical subject headings
- Stroke, Patient Satisfaction, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterviewOther
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.
Focus GroupOther
Focus group topics will fall into the same broad categories as the informational interviews, however will be asked from a caregiver's perspective
| Study group | Role | What they receive |
|---|---|---|
| Stroke Survivors <1 year | Group A will include participants that are less than 1 year out from their most recent stroke. Receives: Other: Informational Interview | |
| Stroke Survivors >1 year | Group B will include participants that are greater than 1 year out from their most recent Receives: Other: Informational Interview | |
| Caregivers | Group C will include participants' identified caregivers. Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment and retention
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.
Measured: July 1,2022-January 20, 2023
Ability to use Zoom platform
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.
Measured: July 1,2022-January 20, 2023
Validity of questions asked to arrive at the themes that will appropriately inform the basis of this proposal
We will extract data from transcriptions of participants' Zoom interviews and perform thematic analysis
Measured: February 2023-May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Feb 2023 (estimated)
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: Study halted prematurely, prior to enrollment of first participant
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.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danny Lee, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350488
- Sponsor's protocol ID
- 300009035
- Status last verified
- Jul 2023
- First submitted
- 30 Mar 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Analysis of the Post-Stroke Continuum Among African Stroke Survivors in Alabama
- ClinicalTrials.gov ID
- NCT05350488
- Acronym / sponsor ID
- 300009035
- Conditions
- Stroke, Disability Physical, Patient Satisfaction, Caregiver Burden
- Keywords
- Rehabilitation, Post-Stroke Rehabilitation Continuum
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 28 Apr 2022 (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 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stroke Survivors <1 year | – | Other: Informational InterviewGroup A will include participants that are less than 1 year out from their most recent stroke. |
| Stroke Survivors >1 year | – | Other: Informational InterviewGroup B will include participants that are greater than 1 year out from their most recent |
| Caregivers | – | Other: Focus GroupGroup C will include participants' identified caregivers. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- African American
- Aged 40 years and older
- Required home health therapy, outpatient therapy, skilled nursing facility or inpatient rehabilitation
- Alabama Resident
- Fluent in English
Key exclusion criteria (4 listed)
- Did not require home health therapy, outpatient therapy or inpatient rehabilitation
- Long term residents of skilled nursing facility
- Severe aphasia
- Severe cognitive impairments
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 |
|---|---|---|
| Informational InterviewInterview 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. | Other | Stroke Survivors <1 year, Stroke Survivors >1 year |
| Focus GroupFocus group topics will fall into the same broad categories as the informational interviews, however will be asked from a caregiver's perspective | Other | Caregivers |
Primary outcome
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.
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.
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Disability Physical, run by University of Alabama at Birmingham.
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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment and retention (time frame: July 1,2022-January 20, 2023). 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 18 Jul 2023.