Myocardial InfarctionNCT02783287
The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients
A study testing Text message reminder for medication adherence and Text message reminder for exercise regimen in people with Myocardial Infarction, run by Brigham and Women's Hospital.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Text message reminder for medication adherence and Text message reminder for exercise regimen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18
- Incarcerated individuals
- Unable to read and write English
- Not in possession of a cell phone
- Patients prescribed medication regimen > 1x/day
About this study
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).
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Text message reminder for medication adherence, Text message reminder for exercise regimen
- Keywords
- Exercise adherence, Medication adherence, Mobile health, Cardiac rehabilitation
- Medical subject headings
- Myocardial Infarction, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message reminder for medication adherenceBehavioural
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 regimenBehavioural
Patients randomized to this arm receive 4 daily text messages reminding them to exercise for 30 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Medication text message | Experimental | Once daily text message reminder. Receives: Behavioral: Text message reminder for medication adherence |
| Exercise text message | Experimental | 4x daily text message reminder. Receives: Behavioral: Text message reminder for exercise regimen |
| Usual care, medication adherence | No intervention | Usual care for medication adherence. |
| Usual care, exercise regimen | No intervention | Usual care for exercise regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Average medication adherence over 12 months after randomization, assessed with self-reported logs
Measured: 12 months
Exercise frequency
Average frequency of exercise over 12 months after randomization, assessed with self-reported logs
Measured: 12 months
Secondary outcomes (2)
Exercise duration
Average duration of exercise assessed by BRUCE protocol
Measured: 12 months
Full medication adherence
Average medication adherence over 12 months greater than .80
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Waterloo
- Responsible party
- Principal investigator, Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
- Investigators
- Niteesh K Choudhry, MD, PhD, Principal investigator, Center for Healthcare Delivery Sciences, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783287
- Sponsor's protocol ID
- 20980
- Status last verified
- May 2016
- First submitted
- 7 Jan 2016
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28778843
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT02783287
- Acronym / sponsor ID
- 20980
- Conditions
- Myocardial Infarction
- Keywords
- Exercise adherence, Medication adherence, Mobile health, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Waterloo
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medication text message | Experimental | Behavioral: Text message reminder for medication adherenceOnce daily text message reminder. |
| Exercise text message | Experimental | Behavioral: Text message reminder for exercise regimen4x daily text message reminder. |
| Usual care, medication adherence | No intervention | –Usual care for medication adherence. |
| Usual care, exercise regimen | No intervention | –Usual care for exercise regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Age < 18
- Incarcerated individuals
- Unable to read and write English
- Not in possession of a cell phone
- Patients prescribed medication regimen > 1x/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message reminder for medication adherencePatients randomized to this arm receive one text message per day (at the scheduled time) reminding them to take their medication. | Behavioural | Medication text message |
| Text message reminder for exercise regimenPatients randomized to this arm receive 4 daily text messages reminding them to exercise for 30 minutes per day. | Behavioural | Exercise text message |
Primary outcome
Medication adherence
Time frame: 12 months
Average medication adherence over 12 months after randomization, assessed with self-reported logs
Exercise frequency
Time frame: 12 months
Average frequency of exercise over 12 months after randomization, assessed with self-reported logs
2 secondary outcomes
Exercise duration
Time frame: 12 months
Full medication adherence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Derived from this study: PubMed 28778843Pandey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niteesh K Choudhry, MD, PhD principal investigator
Center for Healthcare Delivery Sciences, Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Text message reminder for medication adherence and Text message reminder for exercise regimen in people with Myocardial Infarction, run by Brigham and Women's Hospital.
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 6 inclusion and 5 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Medication adherence (time frame: 12 months). 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 NCT02783287, 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 26 May 2016.