Cardiovascular DiseaseIMPACSNCT03414190
Impact of Text Messages to Promote Secondary Prevention After Acute Coronary Syndrome
A study testing Mobile phone text message in people with Cardiovascular Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Mobile phone text message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Nov 2017to Nov 2019
- 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
- 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.
Who cannot join
- Refusal or inability to sign the Informed Consent.
- Complete illiteracy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Luiz Guilherme Passaglia
Belo Horizonte, Minas Gerais, 30575210
Luiz G Passaglia, master's, 3199038674, lg.passaglia@uol.com.br
Luiz G Passaglia, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Mobile phone text message
- Keywords
- Acute Coronary Syndrome, Text Messaging, Risk Factors
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone text messageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Automated semi-personalized mobile phone text message-based intervention for secondary prevention plus usual care. Receives: Behavioral: Mobile phone text message |
| No Intervention | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (9)
Plasma LDL-C level
Fasting blood sample
Measured: 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
Measured: 6 months
Blood Pressure
Measured by research blinded to treatment allocation - 3 resting, sitting digital recordings, mean of last 2 readings
Measured: 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
Measured: 6 months
Body mass index (BMI)
Measured by research blinded to treatment allocation
Measured: 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).
Measured: 6 months
Death from any cause
Medical records and database
Measured: 6 months
Rehospitalization
Self-report, medical records and database
Measured: 6 months
Cardiovascular death
Medical records and database
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start29 Nov 2017
- Primary completionMay 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414190
- Sponsor's protocol ID
- CEP1.883.227
- Acronym
- IMPACS
- Status last verified
- May 2018
- First submitted
- 14 Jan 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mobile Phone Text Messages Intervention on the Secondary Prevention of Cardiovascular Events After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03414190
- Acronym / sponsor ID
- IMPACS / CEP1.883.227
- Conditions
- Cardiovascular Disease
- Keywords
- Acute Coronary Syndrome, Text Messaging, Risk Factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 29 Jan 2018 (actual)
- 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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mobile phone text messageAutomated semi-personalized mobile phone text message-based intervention for secondary prevention plus usual care. |
| No Intervention | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal or inability to sign the Informed Consent.
- Complete illiteracy.
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 |
|---|---|---|
| Mobile phone text messageThe 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. | Behavioural | Experimental |
Primary outcome
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
9 secondary outcomes
Plasma LDL-C level
Time frame: 6 months
Level of physical activity (measured via
Time frame: 6 months
Blood Pressure
Time frame: 6 months
Proportion of non-smokers
Time frame: 6 months
Body mass index (BMI)
Time frame: 6 months
Medication adherence (measured via "Medida de adesão aos tratamentos" - MAT)
Time frame: 6 months
Death from any cause
Time frame: 6 months
Rehospitalization
Time frame: 6 months
Cardiovascular death
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone text message in people with Cardiovascular Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Escore of combined risk factor control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2018.