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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-02-29

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.

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Detailed Description

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Conditions

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Coronary Artery Bypass Grafting (CABG) Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Motivational Interviewing (MI

Intervention Type BEHAVIORAL

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.

volitional intervention

Intervention Type BEHAVIORAL

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.

Usual Care

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

Group Type ACTIVE_COMPARATOR

Routine discharge counseling

Intervention Type BEHAVIORAL

Interventions

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Motivational Interviewing (MI

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.

Intervention Type BEHAVIORAL

volitional intervention

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.

Intervention Type BEHAVIORAL

Routine discharge counseling

Intervention Type BEHAVIORAL

Other Intervention Names

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facilitate behavior change Planning intervention

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No