Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m²)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Community Champions
BehavioralThe UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
Homegrown Heroes
BehavioralMonthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Community ChampionsExperimental treatment 1 intervention
Group B: Homegrown HeroesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in fitness as assessed by the 6 minute walk test
Total distance walked in the 6 minutes walk test in meters
Time frame
Baseline and 6 month follow upSecondary outcomes
1
Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)
Percent change from baseline in hs-cTnT
Time frame
Baseline and 6 month follow up2
Change in hemoglobin A1c
Absolute change from baseline in hemoglobin A1c
Time frame
Baseline and 6 month follow up3
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.
Time frame
Baseline, 6 month follow up, 12 month follow up4
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.
Time frame
Baseline, 6 month follow up, 12 month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov