Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
研究概览
简要总结
The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.
详细描述
The investigators proposed a novel team-based shared decision-making (SDM) program. The overall goal of this proposal is to conduct a pilot randomized controlled trial to evaluate the SDM intervention compared to usual care among 94 adult patients with cardiometabolic factors and cardiovascular-kidney-metabolic (CKM) syndrome at a primary care clinic in Maryland. Participants in the intervention group will receive the 6-month intervention and usual care, while those in the control group will receive usual care. Specific aims include:
Aim 1: To evaluate the feasibility of the Team-Based SDM Program. Feasibility outcomes include recruitment, retention, intervention adherence, and fidelity.
Aim 2: To assess the preliminary efficacy of the Team-Based SDM Program versus usual care in improving clinical, patient-reported, and patient-centered outcomes at 12 weeks post-intervention
Aim 3: To examine the preliminary efficacy of the Team-Based SDM Program versus usual care in improving patients' life's essential 8 and medication adherence from baseline to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD),
- •Are in stage 2 CKM: the presence of metabolic risk factors (hypertension [stages 1 and 2], hypertriglyceridemia [≥135 mg/dL], diabetes, Metabolic Equivalents (MetS)*) and/or Chronic Kidney Disease (CKD) [moderate- to high-risk CKD which are stages 1-3 CKD]), and
- •Receive primary care at Johns Hopkins Community Physicians (JHCP).
- •Access to smart phone or tablet to use app.
排除标准
- •Have diagnosis of CVD,
- •Stage 4-5 CKD, kidney failure, or on dialysis
- •Have a serious medical condition such as cancer;
- •On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months;
- •Have cognitive impairment;
- •Are currently involved in other programs on improving LE8; or
- •Unwillingness to provide informed consent
- •Unable to speak, read, or communicate in English.
研究组 & 干预措施
Team-based shared decision-making
Participants in the intervention arm will receive team-based shared decision-making intervention and usual care.
干预措施: Team-based shared decision-making (Combination Product)
Usual care
Participants in the arm will receive usual care.