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临床试验/NCT06364644
NCT06364644招募中不适用

Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年6月20日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
156
试验地点
2
主要终点
Change in fitness as assessed by the 6 minute walk test
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility.

详细描述

This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 402 individuals from Baltimore City and Hagerstown, Maryland, characterized by low neighborhood and individual socioeconomic status, type 2 diabetes, obesity, and evidence of subclinical heart dysfunction, without a prior clinical diagnosis of heart failure. The 6-month multi-level intervention consists of three key components:

  1. Problem Solving - Diabetes Self-Management Training (DECIDE): Participants will engage in a biweekly evidence-based behavioral change program known as DECIDE. This program focuses on problem-solving training, aiding individuals in managing chronic conditions by overcoming obstacles and challenges. It aims to enhance self-care, improve control of metabolic risk factors, and includes tailored education on heart failure prevention.
  2. Community Health Worker Support: Participants will receive ongoing support from community health workers as part of the intervention. These workers will conduct telephone and/or home visits at least monthly, offering assistance in following areas:
  • Reinforcing patient education about disease self-management
  • Helping patients access care and addressing barriers to care and treatment
  • Serving as facilitators and navigators to clinical care, social services, and other community resources
  • Providing encouragement and support to engage, activate, and empower patients and their support systems
  1. Health Coaching and Partnership with Community Facilities: Participants will engage in supervised aerobic and resistance exercise training at the local Young Men's Christian Associations (YMCAs). The participants will receive instructions on gradually increasing the activity levels throughout the 6-month intervention to achieve physical activity goals (150 minutes of moderate to vigorous exercise per week).

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)

盲法说明

Participants and interventionists will be unblinded, while those assessing outcomes will be blinded to the randomization arm .

入排标准

年龄范围
30 Years 至 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family Healthcare of Hagerstown who live in Washington County
  • •Low socioeconomic status (SES) by high Area Deprivation Index (ADI) [>75th percentile for the state of Maryland] plus low income)
  • •Type 2 diabetes
  • •Obesity (BMI≥30 kg/m^2)

排除标准

  • •Age < 30 or >70 years
  • •Prevalent heart failure
  • •Uncontrolled glycemia (blood glucose <60 mg/d or ≥ 300 mg/dl or most recent hemoglobin A1c ≥11%)
  • •Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications)
  • •Known coronary artery disease (unless < 50% stenosis by angiography)
  • •Moderate or severe valvular heart disease
  • •Serious medical conditions limiting life expectancy or requiring active management
  • •Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+).
  • •Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week
  • •End-stage renal disease
  • •Current participation in another behavior change program
  • •Active alcohol or substance abuse disorder
  • •Already engaging in regular exercise with more than 60 minutes of moderate [3-6 METS] to vigorous [>6 METS] physical activity per week
  • •Active pregnancy
  • •Evidence of ischemia, dangerous arrhythmia, or other clinical instability on baseline exercise stress test

研究组 & 干预措施

Community Champions

Experimental

Participants assigned to the "Community Champions" group will undergo a six-month behavioral intervention. This intervention involves bi-weekly problem-solving training sessions (DECIDE) conducted in groups of 6-10 individuals, along with support from community health workers. Additionally, participants will receive a YMCA membership to exercise with a professional health coach.

干预措施: Community Champions (Behavioral)

Homegrown Heroes

Active Comparator

Participants assigned to the "Homegrown Heroes" will receive a YMCA membership for exercise and a monthly newsletters for 6 months that include education about diabetes self-management, healthy lifestyle and heart failure prevention .

干预措施: Homegrown Heroes (Behavioral)

结局指标

主要结局

Change in fitness as assessed by the 6 minute walk test

时间窗: Baseline and 6 month follow up

Total distance walked in the 6 minutes walk test in meters

次要结局

  • Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test(Baseline, 6 month follow up, 12 month follow up)
  • Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)(Baseline and 6 month follow up)
  • Change in hemoglobin A1c(Baseline and 6 month follow up)
  • Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.(Baseline, 6 month follow up, 12 month follow up)
  • Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)(Baseline, 6 month follow up, 12 month follow up)
  • Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ)(Baseline, 6 month follow up, 12 month follow up)
  • Change in weight (kgs)(Baseline and 6 month follow-up)
  • Change in BMI(Baseline and 6 month follow-up)
  • Change in hip and waist circumference (centimeters)(Baseline and 6 month follow up)
  • Change in Metabolic Syndrome Severity Z score(Baseline and 6 month follow up)
  • Change in self-management as assessed by the Patient Activation Measure (PAM-13).(Baseline, 6 month follow up,12 month follow up)
  • Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10(Baseline, 6 month follow up,12 month follow up)
  • Change in blood pressure (systolic and diastolic (mmHg))(Baseline and 6 month follow up)
  • Change in cardiac biomarker, gal-3(Baseline and 6 month follow up)
  • Change in cardiac biomarkers, NT-proBNP(Baseline and 6 month follow up)
  • Change in cardiac biomarkers, NT-proBNP(Baseline and 6 month follow up)
  • Change in hemoglobin A1c(Baseline and 6 month follow up)
  • Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)(Baseline, 6 month follow up, 12 month follow up)
  • Change in weight (kgs)(Baseline and 6 month follow-up)
  • Change in BMI(Baseline and 6 month follow-up)
  • Change in hip and waist circumference (centimeters)(Baseline and 6 month follow up)
  • Change in self-management as assessed by the Patient Activation Measure (PAM-13).(Baseline, 6 month follow up,12 month follow up)
  • Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)(Baseline and 6 month follow up)
  • Change in blood pressure (systolic and diastolic (mmHg))(Baseline and 6 month follow up)
  • Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.(Baseline, 6 month follow up, 12 month follow up)
  • Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test(Baseline, 6 month follow up, 12 month follow up)
  • Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ)(Baseline, 6 month follow up, 12 month follow up)
  • Change in Metabolic Syndrome Severity Z score(Baseline and 6 month follow up)
  • Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10(Baseline, 6 month follow up,12 month follow up)
  • Change in cardiac biomarker, gal-3(Baseline and 6 month follow up)
  • Change in post-walk Borg dyspnea scale(Baseline and 6 month follow up)
  • Change in cardiorespiratory fitness as assessed by peak oxygen uptake (V02 peak)(Baseline and 6 month follow up)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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