NCT02597205

Brief Summary

The overarching goal of this program to increase the use of evidence-based, secondary-prevention medications and promote healthy lifestyles among myocardial infarction (MI) patients through using provider-facing mobile app and patients-facing text messages.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2015

Shorter than P25 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

June 19, 2015

Last Update Submit

August 23, 2018

Conditions

Myocardial Infarction

Keywords

Medical adherenceLifestyle modificationMobile HealthSecondary Prevention

Outcome Measures

Primary Outcomes (1)

  • Medical adherence change

    Score change measured by the well-validated 4-item Morisky Green Levine Scale

    Three months

Secondary Outcomes (3)

  • Change in diet

    Three months

  • Change in exercise

    Three months

  • Change in smoking habit

    Three months

Study Arms (1)

Mobile app

EXPERIMENTAL

Multi-faceted intervention for physicians and patients respectively: physician-facing app and patient-facing messages

Behavioral: physician-facing app and patient-facing messages

Interventions

physician-facing app and patient-facing messagesBEHAVIORAL

A physician-facing app was designed to help physicians with recruiting and managing patients and with evidence-based medications prescription. Messages were also developed to send to patients to improve their medical adherence and modify lifestyle.

Mobile app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians who: 1) manage MI patients; 2) are interested in and consent to participate in this project; 3) have an Android-based smart phone;
  • Patients who: 1) if they have suffered from a myocardial infraction; 2) they are physical and mentally able to manage their MI conditions; 3) they own a mobile telephone with the ability to read text messages or receive voice messages, and 4) willing to provide informed consent.

You may not qualify if:

  • Physicians who i) do not have an Android smart phone or not being able to use one; ii) do not managing MI patients; iii) current participating in another study.
  • Patients who are: 1) not being able to use a cellphone; 2) severally ill; 3) current participating in another study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hainan Nongken General Hospital

Haikou, Hainan, 570100, China

Location

Shanghai Xietu Street Community Healthcare Center

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (16)

  • Selected leading causes of death.: Statistics Canada; 2005.

    BACKGROUND

  • Global Status Report on Non-Communicable Diseases 2010. Geneva World Health Organization; 2011.

    BACKGROUND

  • Lloyd-Jones DM, Leip EP, Larson MG, D'Agostino RB, Beiser A, Wilson PW, Wolf PA, Levy D. Prediction of lifetime risk for cardiovascular disease by risk factor burden at 50 years of age. Circulation. 2006 Feb 14;113(6):791-8. doi: 10.1161/CIRCULATIONAHA.105.548206. Epub 2006 Feb 6.

    PMID: 16461820BACKGROUND

  • Alwan A, Maclean DR, Riley LM, d'Espaignet ET, Mathers CD, Stevens GA, Bettcher D. Monitoring and surveillance of chronic non-communicable diseases: progress and capacity in high-burden countries. Lancet. 2010 Nov 27;376(9755):1861-8. doi: 10.1016/S0140-6736(10)61853-3. Epub 2010 Nov 10.

    PMID: 21074258BACKGROUND

  • Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001 Nov 27;104(22):2746-53. doi: 10.1161/hc4601.099487.

    PMID: 11723030BACKGROUND

  • Lee DS, Chiu M, Manuel DG, Tu K, Wang X, Austin PC, Mattern MY, Mitiku TF, Svenson LW, Putnam W, Flanagan WM, Tu JV; Canadian Cardiovascular Outcomes Research Team. Trends in risk factors for cardiovascular disease in Canada: temporal, socio-demographic and geographic factors. CMAJ. 2009 Aug 4;181(3-4):E55-66. doi: 10.1503/cmaj.081629. Epub 2009 Jul 20.

    PMID: 19620271BACKGROUND

  • Yusuf S, Islam S, Chow CK, Rangarajan S, Dagenais G, Diaz R, Gupta R, Kelishadi R, Iqbal R, Avezum A, Kruger A, Kutty R, Lanas F, Lisheng L, Wei L, Lopez-Jaramillo P, Oguz A, Rahman O, Swidan H, Yusoff K, Zatonski W, Rosengren A, Teo KK; Prospective Urban Rural Epidemiology (PURE) Study Investigators. Use of secondary prevention drugs for cardiovascular disease in the community in high-income, middle-income, and low-income countries (the PURE Study): a prospective epidemiological survey. Lancet. 2011 Oct 1;378(9798):1231-43. doi: 10.1016/S0140-6736(11)61215-4. Epub 2011 Aug 26.

    PMID: 21872920BACKGROUND

  • Tu JV, Donovan LR, Lee DS, Wang JT, Austin PC, Alter DA, Ko DT. Effectiveness of public report cards for improving the quality of cardiac care: the EFFECT study: a randomized trial. JAMA. 2009 Dec 2;302(21):2330-7. doi: 10.1001/jama.2009.1731. Epub 2009 Nov 18.

    PMID: 19923205BACKGROUND

  • Ahmad M, Schwalm JD, Velianou JL, Natarajan MK. Impact of routine in-hospital assessment of low-density lipoprotein levels and standardized orders on statin therapy in patients undergoing percutaneous coronary interventions. J Invasive Cardiol. 2005 Oct;17(10):518-20.

    PMID: 16204743BACKGROUND

  • Newby LK, LaPointe NM, Chen AY, Kramer JM, Hammill BG, DeLong ER, Muhlbaier LH, Califf RM. Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease. Circulation. 2006 Jan 17;113(2):203-12. doi: 10.1161/CIRCULATIONAHA.105.505636. Epub 2006 Jan 9.

    PMID: 16401776BACKGROUND

  • Hudson M, Richard H, Pilote L. Parabolas of medication use and discontinuation after myocardial infarction--are we closing the treatment gap? Pharmacoepidemiol Drug Saf. 2007 Jul;16(7):773-85. doi: 10.1002/pds.1414.

    PMID: 17486661BACKGROUND

  • Shah ND, Dunlay SM, Ting HH, Montori VM, Thomas RJ, Wagie AE, Roger VL. Long-term medication adherence after myocardial infarction: experience of a community. Am J Med. 2009 Oct;122(10):961.e7-13. doi: 10.1016/j.amjmed.2008.12.021. Epub 2009 Jun 26.

    PMID: 19560749BACKGROUND

  • Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007 Jan 10;297(2):177-86. doi: 10.1001/jama.297.2.177.

    PMID: 17213401BACKGROUND

  • Rublee DA, Chen SY, Mardekian J, Wu N, Rao P, Boulanger L. Evaluation of cardiovascular morbidity associated with adherence to atorvastatin therapy. Am J Ther. 2012 Jan;19(1):24-32. doi: 10.1097/MJT.0b013e3181ee707e.

    PMID: 20838204BACKGROUND

  • Shalev V, Chodick G, Silber H, Kokia E, Jan J, Heymann AD. Continuation of statin treatment and all-cause mortality: a population-based cohort study. Arch Intern Med. 2009 Feb 9;169(3):260-8. doi: 10.1001/archinternmed.2008.552.

    PMID: 19204217BACKGROUND

  • Rodriguez LA, Cea-Soriano L, Martin-Merino E, Johansson S. Discontinuation of low dose aspirin and risk of myocardial infarction: case-control study in UK primary care. BMJ. 2011 Jul 19;343:d4094. doi: 10.1136/bmj.d4094.

    PMID: 21771831BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • JD Schwalm, MD

    Population Health Research Institute, Hamilton Health Sciences Corporation, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

November 5, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

CN(2)