Improving Adherence to Medication After Coronary Artery Bypass Surgery (CABG) in Older Adults
1 other identifier
interventional
288
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2014
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJanuary 11, 2023
January 1, 2023
1.9 years
April 1, 2014
January 9, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (13)
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
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
Mortality rate and Myocardial Infarction
changes from baseline, 6 Months, 12 months and 18 months follow-up
- +8 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALPatients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence
Usual Care
ACTIVE COMPARATORThe usual care group received routine discharge counseling performed by the cardiologists and nurses.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Aged 65 years or older
- Undergoing Elective/subacute multivessel CABG
- Able to give informed consent
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Golestan
Ahvāz, Iran
Mehr
Ahvāz, Iran
Booali Sina Hospital
Qazvin, 3419759811, Iran
Velayat Hospital
Qazvin, Iran
Kosar
Semnan, Iran
Shahid Madani
Tabriz, Iran
Firoozgar
Tehran, Iran
Imam Khomeini
Tehran, Iran
Rajaie
Tehran, Iran
Shariati
Tehran, Iran
Tehran Heart Center
Tehran, Iran
Khatam
Zahedan, Iran
Mousavi
Zanjan, Iran
Related Publications (1)
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.
PMID: 28004259DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir H Pakpour, PhD
Qazvin University Of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 1, 2014
First Posted
April 10, 2014
Study Start
March 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
January 11, 2023
Record last verified: 2023-01