Clinical trial NCT06364644: Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
Official title: Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2diabetes
Heart Failure
Obesity
Keywords: Behavioral Intervention
Diabetes
Heart Failure
Exercise
Obesity
Health Equity
Low Socioeconomic Status
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-04-15
Enrollment: 402
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design of the study is a randomized 2:1 parallel-arm clinical trial.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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+).
* Weight loss of ≥ 5% in the past year or current use of weight loss medications
* 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

Primary outcomes:
measure: Change in post-walk Borg dyspnea scale
timeFrame: Baseline and 6 month follow up
measure: Change in cardiorespiratory fitness as assessed by 6 minute walk test
timeFrame: Baseline and 6 month follow up
measure: Change in cardiorespiratory fitness as assessed by peak oxygen uptake (V02 peak)
timeFrame: Baseline and 6 month follow up
Secondary outcomes:
measure: Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)
timeFrame: Baseline and 6 month follow up
measure: Change in hemoglobin A1c
timeFrame: Baseline and 6 month follow up
measure: Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.
timeFrame: Baseline, 6 month follow up, 12 month follow up
measure: Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)
timeFrame: Baseline, 6 month follow up, 12 month follow up
measure: Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test
timeFrame: Baseline, 6 month follow up, 12 month follow up
measure: Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ)
timeFrame: Baseline, 6 month follow up, 12 month follow up
measure: Change in weight (kgs)
timeFrame: Baseline and 6 month follow-up
measure: Change in BMI
timeFrame: Baseline and 6 month follow-up
measure: Change in hip and waist circumference (centimeters)
timeFrame: Baseline and 6 month follow up
measure: Change in Metabolic Syndrome Severity Z score
timeFrame: Baseline and 6 month follow up
measure: Change in self-management as assessed by the Patient Activation Measure (PAM-13).
timeFrame: Baseline, 6 month follow up,12 month follow up
measure: 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
timeFrame: Baseline, 6 month follow up,12 month follow up
measure: Change in blood pressure (systolic and diastolic (mmHg))
timeFrame: Baseline and 6 month follow up
measure: Change in cardiac biomarker, gal-3
timeFrame: Baseline and 6 month follow up
measure: Change in cardiac biomarkers, NT-proBNP
timeFrame: Baseline and 6 month follow up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Center for Health Equity
state: Maryland
city: Hagerstown
country: United States
facility: Johns Hopkins University Comstock Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Chiadi Ndumele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: