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Cardiovascular DiseaseNCT03098186

TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention

A study testing Intervention SMS in people with Cardiovascular Disease, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose of the trial: To evaluate the efficacy and safety of an intervention with SMS messages delivered by mobiles phones to improve adherence to cardiovascular medications in patients with atherosclerotic cardiovascular disease (ASCVD). 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?
Intervention SMS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
930 participants
Where
1 siteColombia
Study dates
18 Apr 2017to 19 Aug 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

  • Age ≥18 years old
  • History of at least one of the following arterial occlusive events:
  • acute coronary syndrome (unstable angina, acute myocardial infarction with or without ST elevation),
  • stable angina,
  • ischemic cerebrovascular disease,
  • peripheral arterial disease or
Show all 10Show fewer
  • coronary revascularization (coronary artery bypass surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA).
  • Own at least one mobile phone
  • Ability to read and understand text messages (SMS)
  • Intention to stay in the country of recruitment during the next 12 months

Who cannot join

  • Contraindication to take all cardiovascular medications used in secondary prevention.
  • Participation in another randomized clinical trial that could interfere with adherence to treatment.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Fundación Cardiovascular de Colombia

    Floridablanca, Santander Department, 683071

Other trials in Colombia

About this study

Purpose of the trial: To evaluate the efficacy and safety of an intervention with SMS messages delivered by mobiles phones to improve adherence to cardiovascular medications in patients with atherosclerotic cardiovascular disease (ASCVD).

Trial design: Two-parallel arm, single-blind, individually randomized controlled trial.

Read more

Primary endpoint: Differences in changes (baseline minus 12 months) of: Low density lipoprotein cholesterol (LDL-C), Systolic Blood pressure and Heart Rate.

Secondary endpoints: Differences in the changes (baseline minus 12-months) of: (i) adherence to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire; and (ii) Urinary levels of 11 dh-TxB2, Rates of composite end-point of cardiovascular death and hospitalization due to cardiovascular disease up to 12 months, Rates of composite of non-cardiovascular death or hospitalizations due to non-cardiovascular disease up to 12 months and Adverse events: traffic accidents and injuries while reading SMS related to the trial.

Duration of follow-up: 12 months

Trial treatment:

Intervention: The active treatment will consist of SMS that are aimed to modified behavioral factors associated with poor adherence to cardiovascular medications used in secondary prevention. The SMS will be delivered daily during the first month, increasing one day of interval for each week during the second month, and weekly thereafter until end of month 12th. In addition, they will 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.

Control: participants will only receive the 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 = 1600 Recruitment start date: March , 2017 Recruitment end date: September, 2017 Follow-up end date: March, 2018 Number of centers: 1

Statistical considerations:

  • Intention to treat analysis
  • The trial has >90% power (2 sided alpha= 0.05) to detect a reduction in LDL-C as low as 5.1 mg/dl, under the assumption that SMS will increase adherence to statins by 7%.
  • The primary outcomes will be analyzed using ANCOVA.

Partially Financed by COLCIENCIAS Code: 656672553352

Being tested
Intervention SMS, Control SMS
Keywords
Medication adherence, mHealth
Medical subject headings
Cardiovascular Diseases, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention SMSBehavioural

    The active treatment will consist of SMS that are aimed to modified behavioral factors associated with poor adherence to cardiovascular medications used in secondary prevention. The SMS will be delivered daily during the first month, increasing one day of interval for each week during the second month , and weekly thereafter until end of month 12th. In addition, they will 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.

  • Control SMSBehavioural

    Participants will only receive the 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.

Study groups in NCT03098186
Study groupRoleWhat they receive
Intervention SMSActive comparator1. SMS aimed to improved adherence to medications used in secondary prevention of cardiovascular disease. 2. Control SMS: SMS to thanks for participation in the trial and reminders of trial appointments.
Receives: Behavioral: Intervention SMS
Control SMSPlacebo comparatorSMS to thanks for participation in the trial and reminders of trial appointments.
Receives: Behavioral: Control SMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol

    Low density lipoprotein cholesterol (LDL-C) mg/dl

    Measured: Baseline and 12 months

  2. Differences in physiological variables depending on taking medications: Systolic Blood pressure

    Systolic Blood pressure mmHg

    Measured: Baseline and 12 months

  3. Differences in physiological variables depending on taking medications: Heart Rate

    Heart Rate: Heartbeats per minute

    Measured: Baseline and 12 months

Secondary outcomes (7)

  1. Changes in self-reported adherence and recurrence of new cardiovascular and adverse events.

    Adherence to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire

    Measured: Baseline and 12 months

  2. Urinary levels of 11 dh-TxB2

    Changes in Urinary levels of 11 dh-TxB2 pg/dl

    Measured: Baseline and 12 months

  3. Death due to cardiovascular disease

    Rate of death due to cardiovascular disease.

    Measured: Baseline and 12 months

  4. Hospitalization due to cardiovascular disease

    Rate of hospitalization due to cardiovascular disease.

    Measured: Baseline and 12 months

  5. Death due to non-cardiovascular disease

    Rate of death due to non-cardiovascular disease.

    Measured: Baseline and 12 months

  6. Hospitalization due to non-cardiovascular disease

    Rate of hospitalizations due to non-cardiovascular disease.

    Measured: Baseline and 12 months

  7. Adverse events

    Traffic accidents and injuries while reading SMS related to the trial. (Percentage)

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2017
  2. Study start18 Apr 2017
  3. Primary completion19 Aug 2019
  4. Study completion19 Aug 2019

Resources

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
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
930 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03098186
Sponsor's protocol ID
416
Status last verified
Jun 2020
First submitted
10 Mar 2017
Last updated
5 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bermon A, Uribe AF, Perez-Rivero PF, Prieto-Merino D, Saaibi JF, Silva FA, Canon DI, Castillo-Gonzalez KM, Caceres-Rivera DI, Guio E, Meneses-Castillo KJ, Castillo-Meza A, Atkins L, Horne R, Murray E, Serrano NC, Free C, Casas JP, Perel P. Efficacy and Safety of Text Messages Targeting Adherence to Cardiovascular Medications in Secondary Prevention: TXT2HEART Colombia Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Jul 28;9(7):e25548. doi: 10.2196/25548.

    PubMed 34319247

  • Bermon A, Uribe-Rodriguez AF, Perez-Rivero PF, Prieto-Merino D, Caceres Rivera DI, Guio E, Atkins L, Horne R, Murray E, Serrano Diaz NC, Free C, Perel P, Casas JP. Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol. BMJ Open. 2019 Dec 8;9(12):e028017. doi: 10.1136/bmjopen-2018-028017.

    PubMed 31818831

Questions about this trial

What is this clinical trial studying?

A study testing Intervention SMS in people with Cardiovascular Disease, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.

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 10 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: finished, as of the sponsor's last update on 5 Jun 2020. 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 Colombia. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol (time frame: Baseline and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03098186, which also lists 2 linked publications.

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 5 Jun 2020.

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