Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees
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|ClinicalTrials.gov Identifier: NCT02172820|
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Behavioral: Financial incentives||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||February 2018|
Experimental: Financial incentives
Participants receive financial incentives for completing exercise sessions.
Behavioral: Financial incentives
Patients in the experimental group will receive financial incentives for completing exercise sessions.
No Intervention: Control
Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
- Attendance at Cardiac Rehabilitation Exercise Sessions [ Time Frame: 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.
- Change in Physical Health [ Time Frame: Intake, 4 months ]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.
- Changes in Mental Health/Cognition [ Time Frame: 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).
- Maintenance of Physical Health Gains Following Intervention. [ Time Frame: 4 months and 1 year. ]Changes in measures of physical health and fitness (peak oxygen uptake, metabolic equivalents, waist circumference, BMI, treadmill time, smoking status, perceived quality of life) will be measured from completion of intervention (4 months) to 8 months later (1 year follow-up).
- Maintenance of Mental Health/Cognition Scores Following Intervention. [ Time Frame: 4 months and 1 year. ]Changes in measures of mental health (Beck Depression Inventory, Adult Self-Report) as well as changes in measures of executive function (Trail Making and Tower tasks, Delay Discounting, Time Perspective Questionnaire, Stop Signal Task, Behavior Rating Inventory of Executive Function) will be measured from completion of intervention (4 months) to 8 months later (1 year follow-up).
- Health Care Costs [ Time Frame: From intake to one year follow-up ]Health care costs (cost of delivering care at the cardiac rehabilitation clinic as well as hospital costs) will be calculated from study entry to one year follow-up.
- Costs of Attending Care [ Time Frame: Intake to 1 year follow-up ]Costs to the patient of attending care (transportation, child/elder care, missed wages) will be calculated from study entry to one year follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172820
|United States, Vermont|
|University of Vermont|
|Burlington, Vermont, United States, 05401|