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

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ClinicalTrials.gov Identifier: NCT03414190
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: Mobile phone text message Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of a Mobile Phone Text Messages Intervention on the Secondary Prevention of Cardiovascular Events After Acute Coronary Syndrome
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019

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



Primary Outcome Measures :
  1. Escore of combined risk factor control [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Plasma LDL-C level [ Time Frame: 6 months ]
    Fasting blood sample

  2. Level of physical activity (measured via [ Time Frame: 6 months ]
    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

  3. Blood Pressure [ Time Frame: 6 months ]
    Measured by research blinded to treatment allocation - 3 resting, sitting digital recordings, mean of last 2 readings

  4. Proportion of non-smokers [ Time Frame: 6 months ]
    Measured by research blinded to treatment allocation - Self-reported smoking / quitting attempts will be confirmed with a Carbon Monoxide Meter Breath Test

  5. Body mass index (BMI) [ Time Frame: 6 months ]
    Measured by research blinded to treatment allocation

  6. Medication adherence (measured via "Medida de adesão aos tratamentos" - MAT) [ Time Frame: 6 months ]
    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).

  7. Death from any cause [ Time Frame: 6 months ]
    Medical records and database

  8. Rehospitalization [ Time Frame: 6 months ]
    Self-report, medical records and database

  9. Cardiovascular death [ Time Frame: 6 months ]
    Medical records and database



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414190


Locations
Brazil
Luiz Guilherme Passaglia Recruiting
Belo Horizonte, MG, Brazil, 30575210
Contact: Luiz G Passaglia, master's    3199038674    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.         
Sponsors and Collaborators
Federal University of Minas Gerais

Responsible Party: Antonio Luiz Pinho Ribeiro, Principal Investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03414190     History of Changes
Other Study ID Numbers: CEP1.883.227
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais:
Acute Coronary Syndrome
Text Messaging
Risk Factors

Additional relevant MeSH terms:
Cardiovascular Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Vascular Diseases