Feasability and Effectiveness of a Collaborative Care Intervention in the Secondary Prevention of Coronary Heart Disease - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in composite cardiovascular risk score
研究概览
简要总结
The main focus of the pilot study is to evaluate the feasability and effectiveness of a collaborative care intervention for patients suffering from a coronary heart disease (CHD) with insufficient controlled health related risk factors in their lifestyle. The design of the study is a wait list control design. 30 patients will receive treatment immediately after submission, the other 30 after 6 months. An interdisciplinary team, including a care manager for each patient, will offer an individualized treatment plan, based on shared decision making for each patient to reduce risk factors and improve quality of life.
详细描述
The following assumptions will be evaluated:
- The collaborative care concept is feasable in the context of the german health care system and leads to greater patient satisfaction
- The team-based intervention leads to a decrease of cardiovascular risk factors of patients in the intervention group compared to participants in the waitlist condition
- The collaborative care intervention leads to an improvement of quality of life as well as mental well being of participants in the intervention group compared to participants of the waitlist condition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- 否
入选标准
- •both sexes
- •coronary heart disease (angiographically oder clinically approved)
- •sufficient knowledge of the german language
- •at least one not sufficient controlled risk factor : Diabetes mellitus (HbA1c>7,5%), smoking, lack of physical activity (less than 60 minutes of light physical exercise per week), heightened stress level (PSS-4 >5), arterial hypertension (blood pressure despite medication repeatedly heightened >140/90 or in a 24-hour measurement >135/85 mmHg), hypercholesteremia (LDL >130 mg/dl)
- •written informed consent to participate
排除标准
- •no existence of an medically approved coronary heart disease
- •insufficient knowledge of the german language and ulterior disabilities to complete the questionnaires or to understand the education about the Intervention
- •existence of a psychosis
- •drug dependency (except tobacco)
- •severe episode of Depression
- •current suicidal tendency
- •cardiac insufficiency NYHA 4
- •missing informed consent
- •malign tumor (unless curative treated and without relapse)
- •acute coronary syndrome or cardiosurgery within the last 3 months
结局指标
主要结局
Change in composite cardiovascular risk score
时间窗: Baseline to six months
Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below
Patients´ satisfaction with treatment between baseline and the up to 12 months follow-up
时间窗: up to 12 months follow-up
September 2014: baseline for both groups; first 30 participants start with the Intervention, march 2015: 6-months follow-up for intervention group, participants from the wait list group start with active intervention phase, September 2015: 12-months follow-up intervention group; 6-months follow-up participants wait list group, march 2016: 12-months follow-up participants wait list group
次要结局
- Smoking(Baseline and up to 12 months follow-up)
- Lack of physical exercise(Baseline and up to 12 months follow-up)
- Increased HbA1c(Baseline and up to 12 months follow-up)
- Hypertension(Baseline and up to 12 months follow-up)
- Heightened level of stress(Baseline and up to 12 months follow-up)
- LDL cholesterol(Baseline and up to 12 months follow-up)
研究者
Christoph Herrmann-Lingen
Prof. Dr.
University of Göttingen