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

Obesity Clinical Trial

— UNLOAD-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364644
• Other study ID #: IRB00336599
• Secondary ID: 1P50MD017348-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Chiadi Ndumele, MD, PhD
• Phone: 4105022319
• Email: cndumel2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 402
• Est. completion date: June 30, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Meritus Medical Center (MMC) or Family Healthcare of Hagerstown who live in Hagerstown.

• 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)

• Evidence of cardiac dysfunction (by echocardiogram or elevated NT-proBNP [=125 pg/ml])

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Heart Failure
• Obesity

Intervention

Behavioral:
• Community Champions
The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Minority Health and Health Disparities (NIMHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiorespiratory fitness	Changes in peak oxygen uptake (VO2 peak) as assessed by a cardiopulmonary fitness test.	Baseline and 6 month follow up
Secondary	Change in cardiac biomarker, hs-cTnT	Percent change from baseline in hs-cTnT	Baseline and 6 month follow up
Secondary	Change in hemoglobin A1c	Absolute change from baseline in hemoglobin A1c	Baseline and 6 month follow up
Secondary	Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.	The following Health Problem-Solving Scale (HPSS) subscales will be assessed: Impulsive/Careless Problem Solving (IPS), Avoidant Problem Solving (APS), Negative Transfer (NTR), Negative Motivation/Orientation (NMO). Subscale scores are calculated by summing the scores for each item within the respective subscales. Higher subscale scores indicate more of that problem-solving characteristic. The score range for each subscale is as follows: IPS (0-32), APS (0-28), NTR (0-44), NMO (0-20). Total score range 0-124.	Baseline, 6 month follow up, 12 month follow up
Secondary	Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)	The Summary of Diabetes Self-Care Activities Scale (SDSCA) is a tool used to measure diabetes self-care activities. 12-items with 5 sub-scales (diet, exercise, home blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week the behavior was performed (ranges from 0 to 7); The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior.	Baseline, 6 month follow up, 12 month follow up
Secondary	Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test	The Diabetes and CVD Knowledge Test comprises 16 items, featuring both multiple-choice and true-or-false questions. This assessment tool gauges individuals' comprehension of diabetes, its impact on health, and optimal strategies for managing the condition. The possible score range is 0-17. A higher score indicates a better understanding of diabetes and cardiovascular disease.	Baseline, 6 month follow up, 12 month follow up
Secondary	Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ)	The MPAQ is a tool used to estimate the frequency in days (number of times per month) and in time (minutes) someone participated in physical activity (e.g. biking, walking, swimming, etc.). Hours per week for all activities are summed to determine activity hours per week averaged over the past year. A higher sum indicates more physical activity. Values can also be weighted by their estimated metabolic cost and expressed as metabolic equivalent (MET) hours per week. Higher METs are associated with better outcomes.; The MPAQ also assesses inactivity, such as the average number of hours per day spent watching television or being confined to a bed or chair for more than 1 week. A higher average indicates less physical activity.	Baseline, 6 month follow up, 12 month follow up
Secondary	Change in weight (kgs)	Change from baseline in weight (kgs)	Baseline and 6 month follow-up
Secondary	Change in BMI	Change from baseline in BMI (Kg/m^2).	Baseline and 6 month follow-up
Secondary	Change in hip and waist circumference (centimeters)	Change from baseline in hip and waist circumference (centimeters)	Baseline and 6 month follow up
Secondary	Change in Metabolic Syndrome Severity Z score	Metabolic Syndrome Severity (MetS) Z score calculates an individual's metabolic syndrome severity score by examining five key markers: waist circumference, blood pressure, triglycerides, HDL, and fasting glucose. Score typically ranges from -5 to 5. Higher scores indicate greater metabolic syndrome severity.	Baseline and 6 month follow up
Secondary	Change in self-management as assessed by the Patient Activation Measure (PAM-13).	The Patient Activation Measure is a 13-item survey that will assess an individual's knowledge, skills and confidence to managing one's health and healthcare. The PAM scores is calculated and then transformed to a scale with a range from 0-100. A higher PAM score indicates higher patient activation. The score can also be converted into four activation levels: 1 - not believing activation important, 2 - lack of knowledge and confidence to take action, 3 - beginning to take action, 4 - taking action.	Baseline, 6 month follow up,12 month follow up
Secondary	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	The PROMIS Global Health 10 survey comprises 10 items designed to evaluate both physical and mental health status. Scores are aggregated separately for physical and mental health, each ranging from 4 - 20. Higher scores in both categories indicate better outcomes.	Baseline, 6 month follow up,12 month follow up
Secondary	Change in blood pressure (systolic and diastolic (mmHg))	changes in blood pressure from baseline	Baseline and 6 month follow up
Secondary	Change in cardiac biomarker, gal-3	Percent change from baseline in gal-3	Baseline and 6 month follow up
Secondary	Change in cardiac biomarkers, NT-proBNP	Percent change from baseline in NT-proBNP	Baseline and 6 month follow up