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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Grafting (CABG) Surgery
• Intervention / Treatment: Behavioral: Motivational Interviewing (MI; Behavioral: volitional intervention; Behavioral: Routine discharge counseling

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Ahvaz, Iran, Islamic Republic of
    • Golestan
  • Ahvaz, Iran, Islamic Republic of
    • Mehr
  • Qazvin, Iran, Islamic Republic of, 3419759811
    • Booali Sina Hospital
  • Qazvin, Iran, Islamic Republic of
    • Velayat Hospital
  • Semnān, Iran, Islamic Republic of
    • Kosar
  • Tabriz, Iran, Islamic Republic of
    • Shahid Madani
  • Tehran, Iran, Islamic Republic of
    • Firoozgar
  • Tehran, Iran, Islamic Republic of
    • Imam Khomeini
  • Tehran, Iran, Islamic Republic of
    • Rajaie
  • Tehran, Iran, Islamic Republic of
    • Shariati
  • Tehran, Iran, Islamic Republic of
    • Tehran Heart Center
  • Zahedan, Iran, Islamic Republic of
    • Khatam
  • Zanjan, Iran, Islamic Republic of
    • Mousavi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence	Behavioral: 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.; Other Names: facilitate behavior change; 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.; Other Names: Planning intervention
Active Comparator: Usual Care; The usual care group received routine discharge counseling performed by the cardiologists and nurses.	Behavioral: Routine discharge counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences
• Investigators: Principal Investigator: Amir H Pakpour, PhD, Qazvin University of Medical Sciences

Publications and helpful links

General Publications

• Lin CY, Yaseri M, Pakpour AH, Malm D, Brostrom A, Fridlund B, Burri A, Webb TL. Can a Multifaceted Intervention Including Motivational Interviewing Improve Medication Adherence, Quality of Life, and Mortality Rates in Older Patients Undergoing Coronary Artery Bypass Surgery? A Multicenter, Randomized Controlled Trial with 18-Month Follow-Up. Drugs Aging. 2017 Feb;34(2):143-156. doi: 10.1007/s40266-016-0429-3.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 28/20/7200