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NCT Number: NCT07748858

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

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.

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Key information

Conditions

Cardiovascular Cardiovascular Disease Cardiovascular Diseases Chronic Disease Chronic Kidney Diease Chronic Obstructive Pulmonary Disease (COPD) Comorbidity Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Inflammatory Joint Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Metabolic Diseases Multiple Chronic Conditions Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cooper Green Mercy Hospital

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Deborah Ejem, PhD

PRINCIPAL_INVESTIGATOR

Nardakafaria McNeill

CONTACT

[email protected]

205-934-0707

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline and eight weeks post- baseline.

    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.

Secondary outcomes

  1. Treatment Burden Questionnaire (TBQ) Score

    Time frame: Baseline and eight weeks post- baseline

    Perceived treatment burden measured using the 13-item Treatment Burden Questionnaire (TBQ). Each item is rated from 0, indicating not a problem, to 10, indicating a big problem. Item scores will be summed to calculate a total score ranging from 0 to 130. Higher scores indicate greater perceived treatment burden. Scores will be reported at baseline and 8 weeks post-baseline, along with the change from baseline.

  2. Perceived Shared Clinical Decision-Making (CollaboRATE Score)

    Time frame: Baseline and eight week post- baseline

    Patient perception of involvement in shared decision-making measured using the 3-item CollaboRATE questionnaire. Responses to the three items will be averaged to calculate an overall mean score ranging from 1 to 9. Higher scores indicate greater perceived involvement in shared decision-making. Scores will be assessed at baseline and 8 weeks post-baseline, and change from baseline will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Nardakafaria McNeill

CONTACT

[email protected]

205-934-0707

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities: A Pilot Study of the Patient Priorities Care Approach at Cooper Green Mercy Health Services Authority (PPC-HEART)

Acronym: PPC Heart

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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