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

Study Overview
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Brief Summary
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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.

Conditions
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Coronary Artery Bypass Grafting (CABG) Surgery

Intervention / Treatment
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* Behavioral: Motivational Interviewing (MI
* Behavioral: volitional intervention
* Behavioral: Routine discharge counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence | Behavioral: Motivational Interviewing (MI<br>* Five weekly motivational and volitional session sessions and each last about 50 minutes. Five registered psychologists will moderated the session. All MI technique and planing intervention will be used.<br>* Other names: facilitate behavior change;Behavioral: volitional intervention<br>* Five weekly motivational and volitional session sessions and each last about 50 minutes. Five registered psychologists will moderated the session. All MI technique and planing intervention will be used.<br>* Other names: Planning intervention;|
| Active Comparator: Usual Care<br>The usual care group received routine discharge counseling performed by the cardiologists and nurses. | Behavioral: Routine discharge counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Patient-reported medication Adherence to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor) |  | 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 |  | changes from baseline , 6 Months, 12 months and 18 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 action planning | The number of planning strategies is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| Changes in coping planning | The number of planning strategies is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention | 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 | 
| 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 | Patient's habits on medications use before, at baseline, six months, twelve months and eighteen months after the intervention | 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 triglyceride |  | 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 |