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临床试验/NCT02172820
NCT02172820已完成不适用

Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees

University of Vermont2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Attendance at Cardiac Rehabilitation Exercise Sessions

研究概览

简要总结

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. Medicaid coverage and similar state-supported insurance are robust predictors of CR non-participation. There is growing recognition of the need to increase CR among patients with this form of insurance and other economically disadvantaged patients, but there are no evidence-based interventions available for doing so. In the present study we are examining the efficacy of using financial incentives for increasing CR participation among Medicaid patients. Financial incentives have been highly effective in altering other health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss). For this study are randomizing 130 CR-eligible Medicaid enrollees to a treatment condition where they receive financial incentives contingent on initiation of and continued attendance at CR sessions or to a "usual-care" condition where they will not receive these incentives. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, decision making and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of the incentive intervention and usual care conditions with their effects on increasing CR initiation and adherence. Should this intervention be efficacious and cost-effective, it has the potential to substantially increase CR participation and significantly improve health outcomes among low-income cardiac patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A recent myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, heart valve replacement or repair, or stable heart failure.
  • Enrolled in a state-supported insurance plan for low income individuals
  • Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden County) for the next 12 mos.
  • Exclusion criteria:
  • Dementia (MMSE<20) or current untreated Axis 1 psychiatric disorder other than nicotine dependence as determined by medical history
  • Non-English speaking
  • Prior participation in cardiac rehabilitation
  • 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

排除标准

  • 未提供

研究组 & 干预措施

Financial incentives

Experimental

Participants receive financial incentives for completing exercise sessions.

干预措施: Financial incentives (Behavioral)

Control

No Intervention

Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.

结局指标

主要结局

Attendance at Cardiac Rehabilitation Exercise Sessions

时间窗: 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.

次要结局

  • Change in Physical Health(Intake, 4 months)
  • Changes in Mental Health/Cognition(Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diann Gaalema

Assistant Professor of Psychiatry

University of Vermont

研究点 (2)

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