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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05350488
Other study ID # 300009035
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date February 28, 2023

Study information

Verified date July 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Intervention

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.
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Outcome

Type Measure Description Time frame Safety issue
Primary 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. July 1,2022-January 20, 2023
Primary 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. July 1,2022-January 20, 2023
Primary 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 February 2023-May 2023
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