Clinical trial NCT02109523: Improving Adherence to Medication After Coronary Artery Bypass Surgery (CABG) in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Bypass Grafting (CABG) Surgery
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 288
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: changes in Patient-reported medication Adherence to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor)
timeFrame: changes from baseline , 6 Months, 12 months and 18 months after the intervention
measure: Changes in Percent of Patients Adherent to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor) Via Refill Records
timeFrame: changes from baseline , 6 Months, 12 months and 18 months after the intervention
Secondary outcomes:
measure: Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in action planning
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in coping planning
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in quality of life
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Mortality rate and Myocardial Infarction
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in Beliefs about Medications
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in Illness Perceptions
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in habit strength
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in total cholesterol
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in blood pressure
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in triglyceride
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in high-density lipoproteins-cholesterol
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in Low-density lipoproteins-cholesterol
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Golestan
city: Ahvaz
country: Iran, Islamic Republic of
facility: Mehr
city: Qazvin
country: Iran, Islamic Republic of
facility: Booali Sina Hospital
city: Qazvin
country: Iran, Islamic Republic of
facility: Velayat Hospital
city: Semnān
country: Iran, Islamic Republic of
facility: Kosar
city: Tabriz
country: Iran, Islamic Republic of
facility: Shahid Madani
city: Tehran
country: Iran, Islamic Republic of
facility: Firoozgar
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaie
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Heart Center
city: Zahedan
country: Iran, Islamic Republic of
facility: Khatam
city: Zanjan
country: Iran, Islamic Republic of
facility: Mousavi
Study officials:
affiliation: Qazvin University Of Medical Sciences
name: Amir H Pakpour, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.