The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients

May 23, 2016 updated by: Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
The purpose of this study is to assess the impact of text message reminders on adherence to medications and exercise in patients recently discharged from the hospital after a myocardial infarction (MI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Impact of Text Messaging on Medication Adherence and Exercise Regimen among Post-Myocardial Infarction Patients includes two single-center randomized control trials to assess the impact of text message reminds on adherence to medications and exercise regimen in patients recently discharged from the hospital after MI.

Recruitment conducted at Cambridge Cardiac Rehabilitation in Ontario, Canada for both the medication adherence and exercise trial. Potential study subjects are evaluated for inclusion and exclusion criteria, give written informed consent, and are randomized, in a 1:1 ratio, to either intervention or usual care (control).

Patients randomized to the intervention arm in the medication adherence trial receive an automated text message once per day at the time they are prescribed to take their medication. The text message does not contain any personal or pharmacological information.

Patients randomized to the intervention arm in the exercise adherence trial receive four text messages per day at 7:30 am, 12:00 pm, 6:00 pm, and 9:00 pm, reminding them to exercise for 30 minutes per day as per their health care provider.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post-MI hospital discharge within 2 weeks
  • Enrolled in cardiac rehabilitation
  • Prescribed anti-platelets, beta-blockers, ACE-inhibitors or ARBs, and/or statins on 1x/day regimen (for medication adherence trial)
  • Prescribed exercise regimen (for exercise trial)
  • Ability to read and write English
  • Possession of a cell phone with text messaging capability

Exclusion Criteria:

  • Age < 18
  • Incarcerated individuals
  • Unable to read and write English
  • Not in possession of a cell phone
  • Patients prescribed medication regimen > 1x/day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medication text message
Once daily text message reminder.
Behavioral: Text message reminder for medication adherence
Patients randomized to this arm receive one text message per day (at the scheduled time) reminding them to take their medication.
Experimental: Exercise text message
4x daily text message reminder.
Behavioral: Text message reminder for exercise regimen
Patients randomized to this arm receive 4 daily text messages reminding them to exercise for 30 minutes per day.
No Intervention: Usual care, medication adherence
Usual care for medication adherence.
No Intervention: Usual care, exercise regimen
Usual care for exercise regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence
Time Frame: 12 months
Average medication adherence over 12 months after randomization, assessed with self-reported logs
12 months
Exercise frequency
Time Frame: 12 months
Average frequency of exercise over 12 months after randomization, assessed with self-reported logs
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise duration
Time Frame: 12 months
Average duration of exercise assessed by BRUCE protocol
12 months
Full medication adherence
Time Frame: 12 months
Average medication adherence over 12 months greater than .80
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

University of Waterloo

Investigators

  • Principal Investigator: Niteesh K Choudhry, MD, PhD, Center for Healthcare Delivery Sciences, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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