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

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Text message reminder for medication adherence

Text message reminder for exercise regimen

About this trial

This is an interventional health services research trial for Myocardial Infarction focused on measuring Exercise adherence, Medication adherence, Mobile health, Cardiac rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Medication text message

Exercise text message

Usual care, medication adherence

Usual care, exercise regimen

Arm Description

Once daily text message reminder.

4x daily text message reminder.

Usual care for medication adherence.

Usual care for exercise regimen.

Outcomes

Primary Outcome Measures

Medication adherence

Average medication adherence over 12 months after randomization, assessed with self-reported logs

Exercise frequency

Average frequency of exercise over 12 months after randomization, assessed with self-reported logs

Secondary Outcome Measures

Exercise duration

Average duration of exercise assessed by BRUCE protocol

Full medication adherence

Average medication adherence over 12 months greater than .80

Full Information

NCT ID

NCT02783287

First Posted

January 7, 2016

Last Updated

May 23, 2016

Sponsor

Brigham and Women's Hospital

Collaborators

University of Waterloo

1. Study Identification

Unique Protocol Identification Number

NCT02783287

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

University of Waterloo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Exercise adherence, Medication adherence, Mobile health, Cardiac rehabilitation

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medication text message

Arm Type

Experimental

Arm Description

Once daily text message reminder.

Arm Title

Exercise text message

Arm Type

Experimental

Arm Description

4x daily text message reminder.

Arm Title

Usual care, medication adherence

Arm Type

No Intervention

Arm Description

Usual care for medication adherence.

Arm Title

Usual care, exercise regimen

Arm Type

No Intervention

Arm Description

Usual care for exercise regimen.

Intervention Type

Behavioral

Intervention Name(s)

Text message reminder for medication adherence

Intervention Description

Patients randomized to this arm receive one text message per day (at the scheduled time) reminding them to take their medication.

Intervention Type

Behavioral

Intervention Name(s)

Text message reminder for exercise regimen

Intervention Description

Patients randomized to this arm receive 4 daily text messages reminding them to exercise for 30 minutes per day.

Primary Outcome Measure Information:

Title

Medication adherence

Description

Average medication adherence over 12 months after randomization, assessed with self-reported logs

Time Frame

12 months

Title

Exercise frequency

Description

Average frequency of exercise over 12 months after randomization, assessed with self-reported logs

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Exercise duration

Description

Average duration of exercise assessed by BRUCE protocol

Time Frame

12 months

Title

Full medication adherence

Description

Average medication adherence over 12 months greater than .80

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Niteesh K Choudhry, MD, PhD

Organizational Affiliation

Center for Healthcare Delivery Sciences, Brigham and Women's Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28778843

Citation

Pandey A, Krumme AA, Patel T, Choudhry NK. The Impact of Text Messaging on Medication Adherence and Exercise Among Postmyocardial Infarction Patients: Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth. 2017 Aug 3;5(8):e110. doi: 10.2196/mhealth.7144. Erratum In: JMIR Mhealth Uhealth. 2019 Apr 03;7(4):e9254.

Results Reference

derived

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

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