Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07748858
Status
Recruiting
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Conditions

  • Cardiovascular
  • Cardiovascular Disease
  • Chronic Kidney Diease
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Comorbidity
  • Diabetes
  • Inflammatory Joint Diseases

Eligibility Criteria

Sex
ALL
Age
50 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

This is formative evaluation trial guided by the Values Clarification Theory25 and the Cultural Values Theory26, with specific aims to: Aim 1. Develop a culturally appropriate version of the PPC Approach for older AAs with CVCs by assembling a community advisory group of 3 primary care clinicians, 3 older AA patients with CVCs, and 3 AA persons who care for AA patients with CVCs to solicit feedback on the PPC Approach. Aim 2. Determine the acceptability (e.g., program appraisal interviews) and feasibility (e.g., avg. length of program sessions, program participation rate, study completion rate) of the PPC Approach among a sample 20 of under-resourced older southern AA patients with CVCs receiving primary care at Cooper Green Mercy Health Services Authority. Aim 3. Examine the ability of participants to complete pre- and post-test (8 weeks post-baseline) measures of perception of care, treatment burden, shared decision-making, and patient-clinician communication exchange.

Key Dates

First listed
Aug 6, 2026
Start date
May 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
29 participants (estimated)

Arms

  • Arm: Community Advisory Group (CAG) and Pilot Group
    Nine of the 29 participants will participate in Aim 1 of the study, which involves convening a focus group to develop a culturally responsive version of the PPC Approach for underserved African Americans. This number was determined based on qualitative research best practices, which suggest that 6-10 participants per focus group allow for a diverse range of perspectives while maintaining an environment conducive to in-depth discussion. Additionally, this sample size aligns with previous studies that successfully used small, targeted focus groups to refine culturally tailored interventions. Twenty patients will participate in the pilot testing of the newly developed culturally responsive version of the PPC Approach. This number was determined to be satisfactory because it provides a sufficient sample to assess the feasibility and acceptability of the intervention while ensuring a manageable study scope. Prior feasibility studies have demonstrated that sample sizes between 15 and 30 par

Primary Outcome Measure

Older Patient Assessment of Chronic Illness Care (O-PACIC) Score [ Time Frame: Baseline and eight weeks post- baseline. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper Green Mercy HospitalBirminghamAlabama35233
Nardakafaria McNeill
[email protected]
205-934-0707
Deborah Ejem, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Cooper Green Mercy Hospital· Birmingham, AL

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