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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02783287
Other study ID # 20980
Secondary ID
Status Completed
Phase N/A
First received January 7, 2016
Last updated May 23, 2016
Start date January 2012
Est. completion date December 2013

Study information

Verified date May 2016
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital University of Waterloo

Outcome

Type Measure Description Time frame Safety issue
Primary Medication adherence Average medication adherence over 12 months after randomization, assessed with self-reported logs 12 months No
Primary Exercise frequency Average frequency of exercise over 12 months after randomization, assessed with self-reported logs 12 months No
Secondary Exercise duration Average duration of exercise assessed by BRUCE protocol 12 months No
Secondary Full medication adherence Average medication adherence over 12 months greater than .80 12 months No
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