Cardiac RehabilitationPhase 2HeLPNCT03759873
Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program
A Phase 2 study testing Incentives and Case Management in people with Cardiac Rehabilitation, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Incentives and Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 28 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05405
About this study
Official title: Improving Participation in Cardiac Rehabilitation Among Lower-Socioeconomic Status Patients: Efficacy of Early Case Management and Financial Incentives
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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Incentives, Case Management
- Keywords
- Incentives, Case management, Socioeconomic status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncentivesBehavioural
Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.
Case ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Incentives | Experimental | Patient earns incentives for completing cardiac rehabilitation sessions. Receives: Behavioral: Incentives |
| Case Management | Experimental | Patient is assigned a case manager while in hospital. Receives: Behavioral: Case Management |
| Incentives and Case Management | Experimental | Patient receives both the Incentives and Case Management interventions. Receives: Behavioral: Incentives; Behavioral: Case Management |
| Usual care | No intervention | This control condition does not receive either intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Rehabilitation Attendance
Number of cardiac rehabilitation sessions completed out of a possible 36
Measured: Within 4 months of the intake assessment
Cardiac Rehabilitation Completion
Proportion of patients who complete 30+ sessions of cardiac rehabilitation
Measured: Within 4 months of the intake assessment
Secondary outcomes (15)
Change in Fitness (Peak Oxygen Uptake)
Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).
Measured: Within 4 months of the intake assessment
Change in Fitness (Estimated Metabolic Equivalent of Task)
Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).
Measured: Within 4 months of the intake assessment
Change in Body Composition
Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).
Measured: Within 4 months of the intake assessment
Changes in Smoking Status
Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).
Measured: Within 4 months of the intake assessment
Changes in Quality of Life - Cardiac Specific
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.
Measured: Within 4 months of the intake assessment
Changes in Quality of Life - Non-specific
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.
Measured: Within 4 months of the intake assessment
Changes in Mental Health
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.
Measured: Within 4 months of the intake assessment
Changes in Depressive Symptoms
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.
Measured: Within 4 months of the intake assessment
Changes in Executive Function (Delay Discounting)
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.
Measured: Within 4 months of the intake assessment
Changes in Executive Function (DS)
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.
Measured: Within 4 months of the intake assessment
Changes in Executive Function (Trail)
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.
Measured: Within 4 months of the intake assessment
Changes in Executive Function (BRIEF)
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.
Measured: Within 4 months of the intake assessment
Changes in Executive Function (SST)
Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).
Measured: Within 4 months of the intake assessment
Health Care Contacts
Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.
Measured: One year period starting at intake assessment.
Health Care Costs
Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.
Measured: One year period starting at intake assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start3 Dec 2018
- Primary completion1 May 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Diann Gaalema, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759873
- Sponsor's protocol ID
- R61HL143305
- Acronym
- HeLP
- Status last verified
- Sep 2024
- First submitted
- 20 Nov 2018
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaalema DE, Khadanga S, Savage PD, Yant B, Katz BR, DeSarno M, Ades PA. Improving Cardiac Rehabilitation Adherence in Patients With Lower Socioeconomic Status: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1095-1104. doi: 10.1001/jamainternmed.2024.3338.
PubMed 39037811
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Participation in Cardiac Rehabilitation Among Lower-Socioeconomic Status Patients: Efficacy of Early Case Management and Financial Incentives
- ClinicalTrials.gov ID
- NCT03759873
- Acronym / sponsor ID
- HeLP / R61HL143305
- Conditions
- Cardiac Rehabilitation
- Keywords
- Incentives, Case management, Socioeconomic status
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Incentives | Experimental | Behavioral: IncentivesPatient earns incentives for completing cardiac rehabilitation sessions. |
| Case Management | Experimental | Behavioral: Case ManagementPatient is assigned a case manager while in hospital. |
| Incentives and Case Management | Experimental | Behavioral: Incentives, Behavioral: Case ManagementPatient receives both the Incentives and Case Management interventions. |
| Usual care | No intervention | –This control condition does not receive either intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncentivesPatient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. | Behavioural | Incentives, Incentives and Case Management |
| Case ManagementA 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. | Behavioural | Case Management, Incentives and Case Management |
Primary outcome
Cardiac Rehabilitation Attendance
Time frame: Within 4 months of the intake assessment
Number of cardiac rehabilitation sessions completed out of a possible 36
Cardiac Rehabilitation Completion
Time frame: Within 4 months of the intake assessment
Proportion of patients who complete 30+ sessions of cardiac rehabilitation
15 secondary outcomes
Change in Fitness (Peak Oxygen Uptake)
Time frame: Within 4 months of the intake assessment
Change in Fitness (Estimated Metabolic Equivalent of Task)
Time frame: Within 4 months of the intake assessment
Change in Body Composition
Time frame: Within 4 months of the intake assessment
Changes in Smoking Status
Time frame: Within 4 months of the intake assessment
Changes in Quality of Life - Cardiac Specific
Time frame: Within 4 months of the intake assessment
Changes in Quality of Life - Non-specific
Time frame: Within 4 months of the intake assessment
Changes in Mental Health
Time frame: Within 4 months of the intake assessment
Changes in Depressive Symptoms
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (Delay Discounting)
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (DS)
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (Trail)
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (BRIEF)
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (SST)
Time frame: Within 4 months of the intake assessment
Health Care Contacts
Time frame: One year period starting at intake assessment.
Health Care Costs
Time frame: One year period starting at intake assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39037811Gaalema DE, Khadanga S, Savage PD, Yant B, Katz BR, DeSarno M, Ades PA. Improving Cardiac Rehabilitation Adherence in Patients With Lower Socioeconomic Status: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1095-1104. doi: 10.1001/jamainternmed.2024.3338.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Incentives and Case Management in people with Cardiac Rehabilitation, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Rehabilitation Attendance (time frame: Within 4 months of the intake assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03759873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.