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Completed

NCT Number: NCT03759873

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

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.

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Key information

Conditions

Cardiac Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Incentives

Behavioral

Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.

Case Management

Behavioral

A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.

Primary outcomes

  1. Cardiac Rehabilitation Attendance

    Time frame: Within 4 months of the intake assessment

    Number of cardiac rehabilitation sessions completed out of a possible 36

  2. Cardiac Rehabilitation Completion

    Time frame: Within 4 months of the intake assessment

    Proportion of patients who complete 30+ sessions of cardiac rehabilitation

Secondary outcomes

  1. Change in Fitness (Peak Oxygen Uptake)

    Time frame: Within 4 months of the intake assessment

    Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).

  2. Change in Fitness (Estimated Metabolic Equivalent of Task)

    Time frame: Within 4 months of the intake assessment

    Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).

  3. Change in Body Composition

    Time frame: Within 4 months of the intake assessment

    Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).

  4. Changes in Smoking Status

    Time frame: Within 4 months of the intake assessment

    Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).

  5. Changes in Quality of Life - Cardiac Specific

    Time frame: Within 4 months of the intake assessment

    Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.

  6. Changes in Quality of Life - Non-specific

    Time frame: Within 4 months of the intake assessment

    Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.

  7. Changes in Mental Health

    Time frame: Within 4 months of the intake assessment

    Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range.

  8. Changes in Depressive Symptoms

    Time frame: Within 4 months of the intake assessment

    Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intake to completion of the intervention (4 months after intake). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes.

  9. Changes in Executive Function (Delay Discounting)

    Time frame: Within 4 months of the intake assessment

    Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake). A 5-trial adjusting delay discounting task was used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting.

  10. Changes in Executive Function (DS)

    Time frame: Within 4 months of the intake assessment

    Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.

  11. Changes in Executive Function (Trail)

    Time frame: Within 4 months of the intake assessment

    Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.

  12. Changes in Executive Function (BRIEF)

    Time frame: Within 4 months of the intake assessment

    Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems.

  13. Changes in Executive Function (SST)

    Time frame: Within 4 months of the intake assessment

    Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).

  14. Health Care Contacts

    Time frame: One year period starting at intake assessment.

    Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.

  15. Health Care Costs

    Time frame: One year period starting at intake assessment.

    Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.

Other outcomes

  1. Maintenance of Fitness Following Intervention (Peak Oxygen Uptake)

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion).

  2. Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task)

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in fitness level (Estimated Metabolic Equivalent of Task) will be measured from intervention completion until follow-up (8 months after intervention completion).

  3. Maintenance of Waist Circumference Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).

  4. Maintenance of Smoking Status Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).

  5. Maintenance of Quality of Life (Cardiac-specific) Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in perceived quality of life (MacNew) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.

  6. Maintenance of Quality of Life (Noncardiac-specific) Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.

  7. Maintenance of Mental Health Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in mental health (Adult Self-Report) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range.

  8. Maintenance of Depressive Symptoms Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intervention completion until follow-up (8 months after intervention completion). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes.

  9. Maintenance of Executive Function (Delay Discounting) Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion). A 5-trial adjusting delay discounting task will be used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting.

  10. Maintenance of Executive Function (DS) Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.

  11. Maintenance of Executive Function (BRIEF) Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems.

  12. Maintenance of Executive Function (SST) Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).

  13. Maintenance of Executive Function (Trail) Following Intervention.

    Time frame: From completion of intervention (4 months) to follow-up (one-year).

    Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.

  14. Cost-effectiveness

    Time frame: One year period starting at intake assessment.

    Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Improving Participation in Cardiac Rehabilitation Among Lower-Socioeconomic Status Patients: Efficacy of Early Case Management and Financial Incentives

Acronym: HeLP

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Nov 30, 2018
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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