Impact of Text Messages to Promote Secondary Prevention After Acute Coronary Syndrome (IMPACS)

Impact of a Mobile Phone Text Messages Intervention on the Secondary Prevention of Cardiovascular Events After Acute Coronary Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Mobile phone text message

Detailed Description

Purpose of the 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.

Trial design: Two-parallel arm, single-blind, block randomization.

Primary endpoint: The proportion achieving guideline levels of modifiable risk factors (LDL-C <70mg/dL, blood pressure <140/90 mm Hg, exercising regularly [≥5 d/wk × 30minutes of moderate exercise per session], nonsmoker status, and BMI <25). The investigators 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.

Secondary endpoints: The plasma LDL-C level at 6 months, Level of physical activity, Blood Pressure, Medication adherence measured via Morisky scale, Proportion of non-smokers, Body mass index (BMI), Rates death and hospitalization up to 6 months.

Duration of follow-up: 6 months

Trial treatment:

Intervention: 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.

Control: The usual care group will receive standard discharge treatment, instructions, and information for patients with acute coronary syndrome. The participants will also receive SMS thanking for their participation in the trial, reminders of trial appointment and informing if they have changed contact details. The frequency of this SMS will be monthly.

Expected sample size, enrollment and expected number of centers:

Sample size = 160 Recruitment start date: November, 2017 Recruitment end date: May, 2019 Follow-up end date: November, 2019 Number of centers: 1

Statistical considerations:

• Intention to treat analysis
• The trial has >90% power (2 sided alpha = 0.05) to detect 15% difference in achieving risk factor targets in 4 or more of the 5 modifiable risk factors listed.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 30575210
      • Recruiting
      • Luiz Guilherme Passaglia
      • Contact: Luiz G Passaglia, master's; Phone Number: 3199038674; Email: lg.passaglia@uol.com.br
      • Principal Investigator: Luiz G Passaglia, M.D.
      • Principal Investigator: Antônio LP Ribeiro, M.D., Ph.D
      • Sub-Investigator: Luisa CC Brant, M.D., Ph.D
      • Sub-Investigator: Bruno R Nascimento, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Automated semi-personalized mobile phone text message-based intervention for secondary prevention plus usual care.	Behavioral: Mobile phone text message; 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.
No Intervention: No Intervention; Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma LDL-C level	Fasting blood sample	6 months
Level of physical activity (measured via	Measured by research blinded to treatment allocation - The level of physical activity will be mensured by the International Physical Activity Questionnaire Short Form (IPAQ-SF) and it will be validated in one-fifth of the participants by using accelerometers	6 months
Blood Pressure	Measured by research blinded to treatment allocation - 3 resting, sitting digital recordings, mean of last 2 readings	6 months
Proportion of non-smokers	Measured by research blinded to treatment allocation - Self-reported smoking / quitting attempts will be confirmed with a Carbon Monoxide Meter Breath Test	6 months
Body mass index (BMI)	Measured by research blinded to treatment allocation	6 months
Medication adherence (measured via "Medida de adesão aos tratamentos" - MAT)	Measured by research blinded to treatment allocation It is an instrument composed of seven items that evaluate the behavior of the individual in relation to daily use of medicines. The answers are obtained by means of a six-point ordinal scale that varies from always (1) to never (6). The values obtained with the answers to the seven items are summed and divided by the number of items (values vary from 1 to 6). Subsequently, values 5 and 6 are computed as one (adherent) and the others are computed as zero (non-adherent).	6 months
Death from any cause	Medical records and database	6 months
Rehospitalization	Self-report, medical records and database	6 months
Cardiovascular death	Medical records and database	6 months

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: January 14, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Risk Factors; Acute Coronary Syndrome; Text Messaging
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Cardiovascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: CEP1.883.227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No