Improving Adherence to Medication After Coronary Artery Bypass Surgery (CABG) in Older Adults

Qazvin University Of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Bypass Grafting (CABG) Surgery

Treatments: Behavioral: Routine discharge counseling; Behavioral: Motivational Interviewing (MI; Behavioral: volitional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02109523

28/20/7200

Details and patient eligibility

About

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.

Enrollment: 288 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 65 years or older
• Undergoing Elective/subacute multivessel CABG
• Able to give informed consent

Exclusion criteria

• Pregnant
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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288 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence

Treatment:

Behavioral: volitional intervention

Behavioral: Motivational Interviewing (MI

Usual Care

Active Comparator group

Description:

The usual care group received routine discharge counseling performed by the cardiologists and nurses.

Treatment:

Behavioral: Routine discharge counseling