NCT03414190

Brief Summary

The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention after acute coronary syndrome hospitalization. Text messages will include information about lifestyle modifications, medication adherence and cardiovascular risk factor control. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 4 pre-designed and semi-personalized text messages per week in addition to usual care for 6 months, while the control group will receive usual care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 29, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

January 14, 2018

Last Update Submit

May 8, 2018

Conditions

Cardiovascular Disease

Keywords

Acute Coronary SyndromeText MessagingRisk Factors

Outcome Measures

Primary Outcomes (1)

  • Escore of combined risk factor control

    The proportion achieving guideline levels of modifiable risk factors (LDL-C \<77mg/dL, blood pressure \<140/90 mm Hg, exercising regularly \[≥5 d/wk × 30minutes of moderate exercise per session\], nonsmoker status, and BMI \<25). We prespecified in the statistical analysis plan the efficacy variable of proportion achieving combined risk factor control (achieving risk factor targets in 4 or more of the 5 modifiable risk factors listed above) as a measure of a multiple risk factor effect

    6 months

Secondary Outcomes (9)

  • Plasma LDL-C level

    6 months

  • Level of physical activity (measured via

    6 months

  • Blood Pressure

    6 months

  • Proportion of non-smokers

    6 months

  • Body mass index (BMI)

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Automated semi-personalized mobile phone text message-based intervention for secondary prevention plus usual care.

Behavioral: Mobile phone text message

No Intervention

NO INTERVENTION

Usual Care

Interventions

Mobile phone text messageBEHAVIORAL

The treatment group will receive the usual discharge treatment, instructions and information for acute coronary syndrome patients as well as the text-messaging intervention. The program will include a variety of topics such as standard follow-up care reminders as well as general self-management and healthy living habits texts. There will be four streams: one for patients who are non-smokers and are free of diabetes; one for current/recent smokers; one for diabetic patients; and one for smoker and diabetic patients. Texts will be sent out 4 times per week for 180 days. All participants in the same stream will receive the same texts in the same order. The usual care group will receive standard discharge treatment, instructions, and information for patients with acute coronary syndrome. They will also receive simple and short text messages related to the importance of trial participation.

Experimental

Eligibility Criteria

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

You may qualify if:

  • Consecutive patients who have been hospitalized at the UFMG's University Hospital with primary or secondary diagnosis of Acute Coronary Syndrome and are discharged for outpatient follow-up;
  • Age ≥ 18 years, of both sexes;
  • Patients who are able to receive text messages by their own mobile phone.

You may not qualify if:

  • Refusal or inability to sign the Informed Consent.
  • Complete illiteracy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luiz Guilherme Passaglia

Belo Horizonte, Minas Gerais, 30575210, Brazil

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2018

First Posted

January 29, 2018

Study Start

November 29, 2017

Primary Completion

May 1, 2019

Study Completion

November 1, 2019

Last Updated

May 14, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)