Improving Adherence to Medication After Coronary Artery Bypass Surgery (CABG) in Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 13
- 主要终点
- changes in Patient-reported medication Adherence to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor)
研究概览
简要总结
Coronary artery bypass grafting (CABG) surgery is often performed in elderly patients, but non-adherence to post-CABG guideline medications is a common and serious clinical concern in this age group. A recent systematic review found that higher medication adherence significantly improved primary and secondary prevention of coronary artery disease outcomes in all the included studies. Another systematic review assessed studies published from 1999-2009 about motivational interviews, such as implementation intention, in relation to cardiovascular health. They found that motivational interview was an effective means of changing behavior, while offering promise in improving cardiovascular health status. The study is aimed to investigate effectiveness of long term volitional intervention in proving medication adherence in the CABG patient.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years or older
- •Undergoing Elective/subacute multivessel CABG
- •Able to give informed consent
排除标准
- •Already using Dosette boxes (or similar) to improve their medication adherence
- •Currently enrolled in another clinical trial
- •Unable to attend required follow-up visits
- •Mini Mental Status Examination (MMSE) less than 20
- •Significant dysphasia
- •Concomitant surgery
- •Myocardial infarction <48h of surgery
- •Known platelet disease
- •Allergic to aspirin
- •Alcohol or narcotics abuse
- •Geographically not available for follow up
- •Ongoing bleeding
- •Missing written consent
- •Emergency surgery
- •Severe kidney disease (creatinine clearance < 30 ml/min)
- •Oxygen-dependent chronic obstructive pulmonary disease
- •Active hepatitis
- •Significant hepatic failure
- •Prior peptic ulcer• Platelet count < 150 E9
- •Patient has terminal condition and may not survive until 6-month follow-up
- •Patient is a known participant in other RC studies
- •The inability to read and write Persian/Farsi
- •Participants who are not responsible for their own medication
研究组 & 干预措施
Intervention
Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence
干预措施: Motivational Interviewing (MI (Behavioral)
Intervention
Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence
干预措施: volitional intervention (Behavioral)
Usual Care
The usual care group received routine discharge counseling performed by the cardiologists and nurses.
干预措施: Routine discharge counseling (Behavioral)
结局指标
主要结局
changes in Patient-reported medication Adherence to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor)
时间窗: changes from baseline , 6 Months, 12 months and 18 months after the intervention
Changes in Percent of Patients Adherent to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor) Via Refill Records
时间窗: changes from baseline , 6 Months, 12 months and 18 months after the intervention
次要结局
- Changes in action planning(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in coping planning(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in quality of life(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in triglyceride(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Mortality rate and Myocardial Infarction(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in Beliefs about Medications(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in Illness Perceptions(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in habit strength(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in total cholesterol(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in blood pressure(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in high-density lipoproteins-cholesterol(changes from baseline, 6 Months, 12 months and 18 months follow-up)
- Changes in Low-density lipoproteins-cholesterol(changes from baseline, 6 Months, 12 months and 18 months follow-up)
研究者
Amir H Pakpour
Assistant Professor
Qazvin University Of Medical Sciences