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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. African American
  2. Aged 40 years and older
  3. Required home health therapy, outpatient therapy, skilled nursing facility or inpatient rehabilitation
  4. Alabama Resident
  5. Fluent in English
  6. Stroke confirmed by advanced imaging (CT, MRI)
  7. Zoom capability (participants can either have video conference ability or can call into Zoom line)
  8. 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:

  1. Did not require home health therapy, outpatient therapy or inpatient rehabilitation
  2. Long term residents of skilled nursing facility
  3. Severe aphasia
  4. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Stroke Survivors <1 year
Group A will include participants that are less than 1 year out from their most recent stroke.
Other: Informational Interview
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
Other: Informational Interview
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.
Other: Focus Group
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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