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Completed

NCT Number: NCT02109523

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.

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Key information

Conditions

Coronary Artery Bypass Grafting (CABG) Surgery

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Golestan, Ahvāz, Iran

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing (MI

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.

Other names: facilitate behavior change

Volitional intervention

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.

Other names: Planning intervention

Routine discharge counseling

Behavioral

Primary outcomes

  1. changes in Patient-reported medication Adherence to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor)

    Time frame: changes from baseline , 6 Months, 12 months and 18 months after the intervention

  2. Changes in Percent of Patients Adherent to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor) Via Refill Records

    Time frame: changes from baseline , 6 Months, 12 months and 18 months after the intervention

Secondary outcomes

  1. Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  2. Changes in action planning

    Time frame: 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

  3. Changes in coping planning

    Time frame: 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

  4. Changes in quality of life

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  5. Mortality rate and Myocardial Infarction

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  6. Changes in Beliefs about Medications

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  7. Changes in Illness Perceptions

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  8. Changes in habit strength

    Time frame: 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

  9. Changes in total cholesterol

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  10. Changes in blood pressure

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  11. Changes in triglyceride

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  12. Changes in high-density lipoproteins-cholesterol

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

  13. Changes in Low-density lipoproteins-cholesterol

    Time frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2014
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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