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Идёт набор NCT06364644

Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure

Без фазы С лечением Type2diabetes Heart Failure Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Community Champions, Homegrown Heroes.
Кому может быть актуально
Состояния в реестре: Type2diabetes, Heart Failure, Obesity. Базовые параметры: 30 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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 3. 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).

Вмешательства

  • Поведенческое Community Champions
    The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
  • Поведенческое Homegrown Heroes
    Monthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA.

Первичные конечные точки

  • Change in fitness as assessed by the 6 minute walk test [Срок оценки: Baseline and 6 month follow up]
Вторичные конечные точки (12)
  • Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT) [Срок оценки: Baseline and 6 month follow up]
  • Change in hemoglobin A1c [Срок оценки: Baseline and 6 month follow up]
  • Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales. [Срок оценки: 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) [Срок оценки: Baseline, 6 month follow up, 12 month follow up]
  • Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test [Срок оценки: Baseline, 6 month follow up, 12 month follow up]
  • Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ) [Срок оценки: Baseline, 6 month follow up, 12 month follow up]
  • Change in weight (kgs) [Срок оценки: Baseline and 6 month follow-up]
  • Change in BMI [Срок оценки: Baseline and 6 month follow-up]
  • Change in hip and waist circumference (centimeters) [Срок оценки: Baseline and 6 month follow up]
  • Change in Metabolic Syndrome Severity Z score [Срок оценки: Baseline and 6 month follow up]
  • Change in self-management as assessed by the Patient Activation Measure (PAM-13). [Срок оценки: 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 [Срок оценки: Baseline, 6 month follow up,12 month follow up]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 2 центра
  • Johns Hopkins Center for Health Equity — Baltimore
  • Johns Hopkins University Comstock Center — Hagerstown

Идентификаторы

NCT: NCT06364644 · IRB00336599 · 1P50MD017348-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗