Recruiting

PPC Approach

Sponsor:

University of Alabama at Birmingham

Code:

NCT07748858

Conditions

Cardiovascular

Comorbidity

Diabetes

Inflammatory Joint Diseases

Chronic Kidney Diease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Inflammatory Joint Diseases

Chronic Kidney Diease

Study ID

NCT07748858

Start date

May 1, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

29 participants

Anticipated

Interventions and Outcome Measures

Arms

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 and Locations

Central contacts

Nardakafaria McNeill

205-934-0707nmcneill@uab.edu

Locations

Cooper Green Mercy Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Nardakafaria McNeill

205-934-0707nmcneill@uab.edu

Principal Investigator:

Deborah Ejem, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 6, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-06.