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Phase 2 N=209 Randomized Double-blind Treatment

Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program

Cardiac Rehabilitation

Enrolled (actual)
209
Serious AEs
39.6%
Results posted
Oct 2024
Primary outcome: Primary: Cardiac Rehabilitation Attendance — 16.9; 12.0; 24.1; 10.9 sessions of CR

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Incentives (Behavioral); Case Management (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Vermont
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Cardiac Rehabilitation Attendance
16.9; 12.0; 24.1; 10.9
PRIMARY
Cardiac Rehabilitation Completion
22; 13; 32; 4
SECONDARY
Change in Fitness (Peak Oxygen Uptake)
20.9; 18.3; 18.6; 21.2
SECONDARY
Change in Fitness (Estimated Metabolic Equivalent of Task)
7.4; 6.5; 7.0; 6.7
SECONDARY
Change in Body Composition
42.1; 42.7; 42.1; 42.0
SECONDARY
Changes in Smoking Status
8; 10; 11; 5
SECONDARY
Changes in Quality of Life - Cardiac Specific
5.4; 5.4; 5.2; 5.4
SECONDARY
Changes in Quality of Life - Non-specific
66.0; 66.2; 70.3; 64.0
SECONDARY
Changes in Mental Health
54.16; 55.58; 55.41; 52.82
SECONDARY
Changes in Depressive Symptoms
9.0; 6.6; 9.1; 6.6
SECONDARY
Changes in Executive Function (Delay Discounting)
-1.82; -1.94; -2.32; -2.52
SECONDARY
Changes in Executive Function (DS)
8.51; 8.21; 9.16; 8.87
SECONDARY
Changes in Executive Function (Trail)
10.19; 10.19; 10.29; 11.01
SECONDARY
Changes in Executive Function (BRIEF)
55.35; 56.64; 55.67; 54.91
SECONDARY
Changes in Executive Function (SST)
180.86; 182.53; 221.77; 165.26
SECONDARY
Health Care Contacts
113; 180; 201; 142
SECONDARY
Health Care Costs

Summary

Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to participate. Lower socioeconomic status (SES) is a robust predictor of CR non-participation. There is growing recognition of the need to increase CR among economically disadvantaged patients, but there are almost no evidence-based interventions available for doing so. The present study will examine the efficacy of using early case management and financial incentives for increasing CR participation among lower-SES patients. Case management has been effective at promoting attendance at a variety of health-related programs (e.g. treatment for diabetes, HIV, asthma, cocaine dependence) as well as reducing hospitalizations. Financial incentives are also highly effective in altering health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss) including CR participation in a prior trial. For this study 209 CR-eligible lower-SES patients will be randomized to: a treatment condition where patients are assigned a case manager while in hospital who will facilitate CR attendance and coordinate cardiac care, a treatment condition where patients receive financial incentives contingent on initiation of and continued attendance at CR sessions, a combination of these two interventions, or to a "usual-care" condition. Participants in all conditions will complete pre- and post-treatment assessments. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, executive function, and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of delivering the interventions and the usual care condition, taking into account increases in CR participation. Furthermore, the value of the interventions will be modeled based on increases in participation rates, intervention costs, long-term medical costs, and health outcomes after a coronary event. This systematic examination of promising interventions will allow testing of the efficacy and cost-effectiveness of approaches that have the potential to substantially increase CR participation and significantly improve health outcomes among lower-SES cardiac patients.

Eligibility Criteria

Inclusion Criteria

  • A recent myocardial infarction, coronary revascularization, diagnosis of congestive heart failure (CHF) or heart valve replacement or repair
  • Enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need (housing subsidy, food stamps, etc.), or with a less than high school education.
  • Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden county) for the next 12 mos.
  • Copley Hospital (Morrisville, VT) transfer patient (enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need)
  • Northwestern Medical Center (St Albans, VT) transfer patient (enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need)

Exclusion Criteria

  • Dementia (MMSE<20) or current untreated Axis 1 psychiatric disorder other than nicotine dependence as determined by medical history
  • Advanced cancer, advanced frailty, or other longevity-limiting systemic disease that would preclude CR participation
  • Rest angina or very low threshold angina (<2 METS) until adequate therapy is instituted
  • Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator)
  • Class 4 chronic heart failure (symptoms at rest)
  • Exercise-limiting non-cardiac disease such as severe arthritis, past stroke, severe lung disease
  • Previous successful attendance at cardiac rehabilitation (defined as completing 6+ sessions in the past 10 years)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03759873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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