Trial Outcomes & Findings for Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees (NCT NCT02172820)

Last Updated: 2019-06-11

Results Overview

The number of patients who completed cardiac rehabilitation (CR) as defined as greater than or equal to 30 sessions. Must have been completed within 4 months of the entry stress test.

Recruitment status

COMPLETED

Study phase

Target enrollment

130 participants

Primary outcome timeframe

Within 4 months of initial stress test

Results posted on

2019-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Financial Incentives Participants receive financial incentives for completing exercise sessions. Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions.	Control Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
Overall Study STARTED	65	65
Overall Study COMPLETED	65	65
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Financial Incentives n=65 Participants Participants receive financial incentives for completing exercise sessions. Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions.	Control n=65 Participants Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.	Total n=130 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 11.0 • n=5 Participants	55.8 years STANDARD_DEVIATION 9.2 • n=7 Participants	57.1 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	21 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	44 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	61 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants	65 participants n=7 Participants	130 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 4 months of initial stress test

The number of patients who completed cardiac rehabilitation (CR) as defined as greater than or equal to 30 sessions. Must have been completed within 4 months of the entry stress test.

Outcome measures

Outcome measures
Measure	Financial Incentives n=65 Participants Participants receive financial incentives for completing exercise sessions. Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions.	Control n=65 Participants Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
Attendance at Cardiac Rehabilitation Exercise Sessions	36 Participants	19 Participants

SECONDARY outcome

Timeframe: Intake, 4 months

Population: Despite having 65 subjects in each of the two groups (financial incentives and control), only 55 and 57 subjects were analyzed respectively. Not every subject completed the initial intake (lost contact with 10 and 8 subjects, respectively).

Secondary outcomes included changes between baseline and 4-month assessment in fitness (peak oxygen uptake directly measured by expired gas analysis or estimated by metabolic equivalents), body composition (body mass index, waist circumference), and quality of life (MacNew).The MacNew was designed to evaluate how daily activities and physical,emotional and social functioning are affected by heart disease and its treatment. It consists of 27 questions grouped into 3 domains: physical, mental and social functioning. Both subscales and summary score are interpreted as scores between 1 and 7; higher scores are better, and a change of at least 0.5 is a useful indicator of the minimal important difference.Changes over time were assessed using paired differences in scores from intake to four months. Due to non-normal distributions, Wilcoxon Signed Rank Test was used. Contributions of other variables to changes in secondary outcomes were examined using analyses of covariance.

Outcome measures

Outcome measures
Measure	Financial Incentives n=55 Participants Participants receive financial incentives for completing exercise sessions. Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions.	Control n=57 Participants Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
Change in Physical Health % change BMI	0.53 percentage of change Interval -1.35 to 1.25	1.87 percentage of change Interval -1.52 to 2.06
Change in Physical Health % change VO2	6.33 percentage of change Interval 3.68 to 12.3	12.54 percentage of change Interval 6.01 to 21.1
Change in Physical Health % change Waist	-1.12 percentage of change Interval -3.02 to 0.67	-0.23 percentage of change Interval -2.32 to 1.61
Change in Physical Health % change cardiac-specific quality of life (MacNew)	6.63 percentage of change Interval 3.7 to 14.53	10.73 percentage of change Interval 6.68 to 18.35

SECONDARY outcome

Timeframe: Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)

The Achenbach System of Empirically Based Assessment (ASEABA) is an integrated system of multi-informant assessments, including self-reports, to measure adaptive functioning and problems. The problem items have been factor-analytically reduced to 8 syndrome scales that are consistent across age, informant and culture. Higher scores represent higher symptoms (e.g. emotional/behavioral problems). The Stop Signal Reaction Time (SSRT) task measures the ability to inhibit incorrect responses. Lower scores represent a better ability to inhibit reactions. The BRIEF-A is a rating scale developed to look at everyday behaviors associated with specific domains of executive functions in adults ages 18-90.T-scores (standardized scores) are used to interpret the individual's level of executive functioning (EF). Higher scores represent more self-reported problems. A score of 50 represents the mean.A difference of 10 from the mean indicates a difference of one standard deviation (SD).

Outcome measures

Outcome measures
Measure	Financial Incentives n=65 Participants Participants receive financial incentives for completing exercise sessions. Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions.	Control n=65 Participants Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
Changes in Mental Health/Cognition % change ASEABA	-2.03 percentage of change Interval -6.68 to -0.31	1.03 percentage of change Interval -1.72 to 6.1
Changes in Mental Health/Cognition % change SSRT	3.03 percentage of change Interval -4.87 to 25.25	16.10 percentage of change Interval -1.17 to 36.78
Changes in Mental Health/Cognition % change BRIEF - A	-6.23 percentage of change Interval -11.27 to -3.57	0.97 percentage of change Interval -3.62 to 8.96

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months and 1 year.

Other events: 30 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Financial Incentives n=65 participants at risk Participants receive financial incentives for completing exercise sessions. Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions. 39% fewer hospital contacts in the incentive condition (p=0.079)	Control n=65 participants at risk Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
Cardiac disorders Hospitalizations	29.2% 19/65 • Number of events 28 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	27.7% 18/65 • Number of events 32 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Gastrointestinal disorders Hospitalizations	4.6% 3/65 • Number of events 4 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	7.7% 5/65 • Number of events 8 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalizations	4.6% 3/65 • Number of events 3 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	6.2% 4/65 • Number of events 4 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Vascular disorders Hospitalizations	3.1% 2/65 • Number of events 2 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	3.1% 2/65 • Number of events 2 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Injury, poisoning and procedural complications Hospitalizations	4.6% 3/65 • Number of events 3 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Infections and infestations Hospitalizations	3.1% 2/65 • Number of events 2 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	4.6% 3/65 • Number of events 3 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Eye disorders Hospitalizations	1.5% 1/65 • Number of events 2 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Renal and urinary disorders Hospitalizations	1.5% 1/65 • Number of events 2 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	3.1% 2/65 • Number of events 2 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Respiratory, thoracic and mediastinal disorders Hospitalizations	4.6% 3/65 • Number of events 3 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	6.2% 4/65 • Number of events 6 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Endocrine disorders Hospitalizations	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Nervous system disorders Hospitalizations	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	4.6% 3/65 • Number of events 4 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Blood and lymphatic system disorders Hospitalizations	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Musculoskeletal and connective tissue disorders Hospitalizations	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record

Other adverse events

Additional Information

Diann Gaalema, Ph.D., PI

The University of Vermont

Phone: 802-656-9874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Financial Incentives n=65 participants at risk Participants receive financial incentives for completing exercise sessions. Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions. 39% fewer hospital contacts in the incentive condition (p=0.079)	Control n=65 participants at risk Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
Cardiac disorders Emergency Department Visit	10.8% 7/65 • Number of events 7 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	27.7% 18/65 • Number of events 33 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Respiratory, thoracic and mediastinal disorders Emergency Department Visit	12.3% 8/65 • Number of events 11 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	9.2% 6/65 • Number of events 9 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Gastrointestinal disorders Emergency Department Visit	6.2% 4/65 • Number of events 4 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Blood and lymphatic system disorders Emergency Department Visit	3.1% 2/65 • Number of events 5 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Renal and urinary disorders Emergency Department Visit	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	3.1% 2/65 • Number of events 2 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Eye disorders Emergency Department Visit	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Reproductive system and breast disorders Emergency Department Visit	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Injury, poisoning and procedural complications Emergency Department Visit	3.1% 2/65 • Number of events 2 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	6.2% 4/65 • Number of events 4 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Endocrine disorders Emergency Department Visit	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Nervous system disorders Emergency Department Visit	4.6% 3/65 • Number of events 4 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	6.2% 4/65 • Number of events 6 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Infections and infestations Emergency Department Visit	4.6% 3/65 • Number of events 3 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	4.6% 3/65 • Number of events 3 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
General disorders Emergency Department Visit	10.8% 7/65 • Number of events 9 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	9.2% 6/65 • Number of events 13 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Musculoskeletal and connective tissue disorders Emergency Department Visit	12.3% 8/65 • Number of events 8 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	12.3% 8/65 • Number of events 12 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Psychiatric disorders Emergency Department Visit	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record
Surgical and medical procedures Emergency Department Visit	0.00% 0/65 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record	1.5% 1/65 • Number of events 1 • 1 year Emergency Department (ED) visits and hospitalizations were pulled from the medical record