Koronare Herzkrankheit Projekt Mannheim
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Change in health outcomes
研究概览
简要总结
This randomized controlled trial (RCT) will examine a case management program for patients suffering from coronary heart disease with multimorbidity in Mannheim, Germany. The trail consists of 3 treatment arms: 1) intensified case management; 2) social interaction alone 3) standard care. The main objectives are to evaluate how case management and social interaction alone compared to standard medical care affect the primary and secondary outcomes: physical health, quality of life, loneliness, depression, self-efficacy, outcome expectancies, social support, health locus of control, lifestyle behavior, social network, vulnerability, intention, severity, health worries and cognitive functions.
详细描述
This randomized controlled trial (RCT) will examine a case management program for 320 male and female patients suffering from coronary heart disease with multimorbidity in Mannheim, Germany. The main objectives are to evaluate how case management and social interaction alone compared to standard medical care affect the primary and secondary outcomes: physical health, quality of life, loneliness, depression, self-efficacy, outcome expectancies, social support, health locus of control, lifestyle behavior, social network, vulnerability, intention, severity, health worries and cognitive functions.
Additionally, the secondary outcomes are studied as factors that mediate the effects of case management and social interaction alone compared to standard medical care on the primary outcomes.
The trail consists of 3 treatment arms: 1) intensified case management; 2) social interaction alone 3) usual care. The intervention consists of a biweekly contact by trained case managers over the first 6-months and a monthly contact over the subsequent 6-months. Each contact involves an assessment of well-being, daily life, problems and offering emotional support and solutions or refer to the general practitioner if necessary (both intervention groups).
For patients assigned to the "CM CHD" the contacts include medical control (like blood pressure or weight) and well-being as well as an additional core set of relevant outcome measures (e.g. need for treatment of fatigue).
Patients assigned to the control group received usual care (no CM or contact). An additional fourth group is monitored. This group is consisting of patients who refused to take part in the study but gave consent to collect their practice data (not randomized).
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed CHD
- •participation in the Disease Management Program (DMP) of CHD or
- •a risk score (Framingham or Procam) higher than 20%
- •two additional chronic diseases (multimorbid)
排除标准
- •Patients living in institutionalized care
- •Patients having dementia
- •Patients associated with a life expectancy of less than one year
- •Patients who are not able to communicate in German language
结局指标
主要结局
Change in health outcomes
时间窗: Measured at baseline, 6 and 12 months follow-up
This includes biomarkers (blood pressure, BMI, weight, blood lipids), physical balance performance (semi tandem stand), care utilization and medication usage, clinical assessments and need for (medical) treatment (like dyspnea, fatigue, care, vomitus, thirst, lack of appetite, nausea, disorientation). Within the intervention group CM CHD weight and blood pressure is self-reported by patients biweekly within the first six months and monthly within the second six months.
Change in quality of life
时间窗: Measured at baseline, 6 and 12 months follow-up
We will measure this variable using the "EQ-5D" and two additional items.
次要结局
- Change in Loneliness(Measured at baseline, 6 and 12 months follow-up)
- Change in Depression(Measured at baseline, 6 and 12 months follow-up)
- Change in self-efficacy(Measured at baseline, 6 and 12 months follow-up)
- Change in social support(Measured at baseline, 6 and 12 months follow-up)
- Change in health locus of control(Measured at baseline, 6 and 12 months follow-up)
- Change in lifestyle behavior(Measured at baseline, 6 and 12 months follow-up)
- Change in social network of family and friends(Measured at baseline, 6 and 12 months follow-up)
- Change in outcome expectancies(Measured at baseline, 6 and 12 months follow-up)
- Change in vulnerability(Measured at baseline, 6 and 12 months follow-up)
- Change in intention(Measured at baseline, 6 and 12 months follow-up)
- Change in severity(Measured at baseline, 6 and 12 months follow-up)
- Change in health worries(Measured at baseline, 6 and 12 months follow-up)
- Change in cognitive functions(Measured at baseline, 6 and 12 months follow-up)