Improving Adherence to Medication After Coronary Artery Bypass Surgery (CABG) in Older Adults
- Conditions
- Coronary Artery Bypass Grafting (CABG) Surgery
- Interventions
- Behavioral: Motivational Interviewing (MIBehavioral: Routine discharge counselingBehavioral: volitional intervention
- Registration Number
- NCT02109523
- Lead Sponsor
- Qazvin University Of Medical Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 288
- Aged 65 years or older
- Undergoing Elective/subacute multivessel CABG
- Able to give informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention volitional intervention Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence Intervention Motivational Interviewing (MI Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence Usual Care Routine discharge counseling The usual care group received routine discharge counseling performed by the cardiologists and nurses.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 action planning changes from baseline, 6 Months, 12 months and 18 months follow-up The number of planning strategies is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention
Changes in coping planning changes from baseline, 6 Months, 12 months and 18 months follow-up The number of planning strategies is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention
Changes in quality of life changes from baseline, 6 Months, 12 months and 18 months follow-up 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 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 changes from baseline, 6 Months, 12 months and 18 months follow-up Patient's habits on medications use before, at baseline, six months, twelve months and eighteen months after the intervention
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
Trial Locations
- Locations (13)
Rajaie
🇮🇷Tehran, Iran, Islamic Republic of
Shariati
🇮🇷Tehran, Iran, Islamic Republic of
Khatam
🇮🇷Zahedan, Iran, Islamic Republic of
Velayat Hospital
🇮🇷Qazvin, Iran, Islamic Republic of
Mousavi
🇮🇷Zanjan, Iran, Islamic Republic of
Kosar
🇮🇷Semnān, Iran, Islamic Republic of
Shahid Madani
🇮🇷Tabriz, Iran, Islamic Republic of
Imam Khomeini
🇮🇷Tehran, Iran, Islamic Republic of
Tehran Heart Center
🇮🇷Tehran, Iran, Islamic Republic of
Golestan
🇮🇷Ahvaz, Iran, Islamic Republic of
Booali Sina Hospital
🇮🇷Qazvin, Iran, Islamic Republic of
Mehr
🇮🇷Ahvaz, Iran, Islamic Republic of
Firoozgar
🇮🇷Tehran, Iran, Islamic Republic of