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

NCT07748858 | Recruiting

• 2 other identifiers: IRB-300013717NIMHD
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Cardiovascular Diseases; Chronic Kidney Disease; Chronic Obstructive Pulmonary Disease; Patient-Centered Care; Shared Decision Making; Care Coordination; Older Adults; Multiple Chronic Conditions

Outcome Measures

Primary Outcomes (1)

• Older Patient Assessment of Chronic Illness Care (O-PACIC) Score

  Patient experience with integrated care delivery and self-management support measured using the 10-item Older Patient Assessment of Chronic Illness Care (O-PACIC) questionnaire. Responses to the 10 items will be summed to calculate a total score ranging from 10 to 50. Higher scores indicate more positive perceptions of chronic illness care. Scores will be reported at baseline and 8 weeks post-baseline, along with the change from baseline.

  Baseline and eight weeks post- baseline.

Secondary Outcomes (2)

• Treatment Burden Questionnaire (TBQ) Score

  Baseline and eight weeks post- baseline

• Perceived Shared Clinical Decision-Making (CollaboRATE Score)

  Baseline and eight week post- baseline

Study Arms (1)

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

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cooper Green Mercy Hospital

You may qualify if:

• greater than or equal to 50 years old
• at least one CVD (i.e., coronary artery disease, hypertension, heart failure, arrhythmias, cardiomyopathy, peripheral artery disease, stroke, and valvular heart disease)
• at least one coexisting chronic condition (i.e., inflammatory joint disease, COPD/asthma, diabetes, chronic kidney disease, and cancer one-year post-treatment)
• a caregiver of a participant, or a provider who serves this population.

You may not qualify if:

• Axis I psychiatric (schizophrenia, bipolar disorder), dementia, suicidal ideation,
• active substance use disorder nursing home or assisted living facility residence.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Cooper Green Mercy Hospital

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Renal Insufficiency, Chronic; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Deborah Ejem

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nardakafaria McNeill

CONTACT

205-934-0707; nmcneill@uab.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)