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AzTrials

Coronary Artery Bypass Grafting (CABG) SurgeryPhase 2NCT02109523

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

A Phase 2 study testing Motivational Interviewing (MI, volitional intervention and Routine discharge counseling in people with Coronary Artery Bypass Grafting (CABG) Surgery, run by Qazvin University Of Medical Sciences at 13 sites in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Motivational Interviewing (MI, volitional intervention and Routine discharge counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
13 sitesIran
Study dates
Mar 2014to Feb 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Aged 65 years or older
  • Undergoing Elective/subacute multivessel CABG
  • Able to give informed consent

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Iran13 sites

  • Golestan

    Ahvāz

  • Mehr

    Ahvāz

  • Booali Sina Hospital

    Qazvin, 3419759811

  • Velayat Hospital

    Qazvin

  • Kosar

    Semnan

  • Shahid Madani

    Tabriz

  • Firoozgar

    Tehran

  • Imam Khomeini

    Tehran

  • Rajaie

    Tehran

  • Shariati

    Tehran

  • Tehran Heart Center

    Tehran

  • Khatam

    Zahedan

  • Mousavi

    Zanjan

Other trials in Iran

About this study

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.

Being tested
Motivational Interviewing (MI, volitional intervention, Routine discharge counseling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational Interviewing (MIBehavioural

    Also called facilitate behavior change

    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.

  • volitional interventionBehavioural

    Also called Planning 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.

  • Routine discharge counselingBehavioural

Study groups in NCT02109523
Study groupRoleWhat they receive
InterventionExperimentalPatients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence
Receives: Behavioral: Motivational Interviewing (MI; Behavioral: volitional intervention
Usual CareActive comparatorThe usual care group received routine discharge counseling performed by the cardiologists and nurses.
Receives: Behavioral: Routine discharge counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

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

Secondary outcomes (13)

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

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

  2. 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

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

  3. 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

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

  4. Changes in quality of life

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

  5. Mortality rate and Myocardial Infarction

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

  6. Changes in Beliefs about Medications

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

  7. Changes in Illness Perceptions

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

  8. Changes in habit strength

    Patient's habits on medications use before, at baseline, six months, twelve months and eighteen months after the intervention

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

  9. Changes in total cholesterol

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

  10. Changes in blood pressure

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

  11. Changes in triglyceride

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

  12. Changes in high-density lipoproteins-cholesterol

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

  13. Changes in Low-density lipoproteins-cholesterol

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02109523
Sponsor's protocol ID
28/20/7200
Status last verified
Jan 2023
First submitted
1 Apr 2014
Last updated
11 Jan 2023
Results posted
No

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.

    PubMed 28004259

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Motivational Interviewing (MI, volitional intervention and Routine discharge counseling in people with Coronary Artery Bypass Grafting (CABG) Surgery, run by Qazvin University Of Medical Sciences at 13 sites in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02109523, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.

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