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Recruiting NCT07748858

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

Observational Cardiovascular Comorbidity Diabetes Inflammatory Joint Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular, Comorbidity, Diabetes, Inflammatory Joint Diseases. Basic parameters: 50 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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)

Overview

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.

Primary outcome measures

  • Older Patient Assessment of Chronic Illness Care (O-PACIC) Score [Time frame: Baseline and eight weeks post- baseline.]
Secondary outcome measures (2)
  • Treatment Burden Questionnaire (TBQ) Score [Time frame: Baseline and eight weeks post- baseline]
  • Perceived Shared Clinical Decision-Making (CollaboRATE Score) [Time frame: Baseline and eight week post- baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Cooper Green Mercy Hospital — Birmingham

Identifiers

NCT: NCT07748858 · IRB-300013717 · NIMHD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗