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Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities (PPC Heart)

2026年7月31日 更新者：Deborah Ejem、University of Alabama at Birmingham

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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

29

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Nardakafaria McNeill
  • 电话号码：205-934-0707
  • 邮箱：nmcneill@uab.edu

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • 招聘中
        • Cooper Green Mercy Hospital
        • 接触：
        • 首席研究员：
          • Deborah Ejem, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Cooper Green Mercy Hospital

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Older Patient Assessment of Chronic Illness Care (O-PACIC) Score
大体时间：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.
Baseline and eight weeks post- baseline.

次要结果测量

结果测量
措施说明
大体时间
Treatment Burden Questionnaire (TBQ) Score
大体时间：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.
Baseline and eight weeks post- baseline
Perceived Shared Clinical Decision-Making (CollaboRATE Score)
大体时间：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.
Baseline and eight week post- baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Alabama at Birmingham

合作者

National Institute on Minority Health and Health Disparities (NIMHD)

调查人员

  • 首席研究员：Deborah Ejem、University of Alabama at Birmingham

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年7月31日

首先提交符合 QC 标准的

2026年7月31日

首次发布 (实际的)

2026年8月6日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB-300013717
  • NIMHD (其他标识符：National Institute on Minority Health and Health Disparities)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data from this small pilot study will not be shared with other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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