CardiovascularPPC HeartNCT07748858
Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities
An observational study of Cardiovascular and Comorbidity, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Cardiovascular, Comorbidity, Diabetes
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cooper Green Mercy Hospital
Who may be able to join
- 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.
Who cannot join
- Axis I psychiatric (schizophrenia, bipolar disorder), dementia, suicidal ideation,
- active substance use disorder nursing home or assisted living facility residence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cooper Green Mercy Hospital
Birmingham, Alabama, 35233
Nardakafaria McNeill, 205-934-0707, nmcneill@uab.edu
Deborah Ejem, PhD
About this study
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)
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, 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
- Medical subject headings
- Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Renal Insufficiency, Chronic, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and eight weeks post- baseline.
Secondary outcomes (2)
Treatment Burden Questionnaire (TBQ) Score
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.
Measured: Baseline and eight weeks post- baseline
Perceived Shared Clinical Decision-Making (CollaboRATE Score)
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.
Measured: Baseline and eight week post- baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 May 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Deborah Ejem, University of Alabama at Birmingham
- Investigators
- Deborah Ejem, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748858
- Sponsor's protocol ID
- IRB-300013717
- Other IDs
- NIMHD
- Acronym
- PPC Heart
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data from this small pilot study will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07748858
- Acronym / sponsor ID
- PPC Heart / IRB-300013717
- Conditions
- Cardiovascular, Comorbidity, Diabetes, Inflammatory Joint Diseases, Chronic Kidney Diease, 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cooper Green Mercy Hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Axis I psychiatric (schizophrenia, bipolar disorder), dementia, suicidal ideation,
- active substance use disorder nursing home or assisted living facility residence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data from this small pilot study will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Ejem principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular and Comorbidity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nardakafaria McNeill (205-934-0707, nmcneill@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Older Patient Assessment of Chronic Illness Care (O-PACIC) Score (time frame: Baseline and eight weeks post- baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.