Purpose

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

Eligibility

Eligible Ages
Between 50 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Cooper Green Mercy Hospital
Birmingham, Alabama 35233
Contact:
Nardakafaria McNeill
205-934-0707
nmcneill@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Nardakafaria McNeill
205-934-0707
nmcneill@uab.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.