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TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention
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.
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Santander
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Floridablanca, Santander, Colombia, 683071
- Fundacion Cardiovascular de Colombia
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Contraindication to take all cardiovascular medications used in secondary prevention.
- Participation in another randomized clinical trial that could interfere with adherence to treatment.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Intervention SMS
|
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.
|
Placebo-vergelijker: Control SMS
SMS to thanks for participation in the trial and reminders of trial appointments.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol
Tijdsspanne: Baseline and 12 months
|
Low density lipoprotein cholesterol (LDL-C) mg/dl
|
Baseline and 12 months
|
Differences in physiological variables depending on taking medications: Systolic Blood pressure
Tijdsspanne: Baseline and 12 months
|
Systolic Blood pressure mmHg
|
Baseline and 12 months
|
Differences in physiological variables depending on taking medications: Heart Rate
Tijdsspanne: Baseline and 12 months
|
Heart Rate: Heartbeats per minute
|
Baseline and 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Changes in self-reported adherence and recurrence of new cardiovascular and adverse events.
Tijdsspanne: Baseline and 12 months
|
Adherence to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire
|
Baseline and 12 months
|
Urinary levels of 11 dh-TxB2
Tijdsspanne: Baseline and 12 months
|
Changes in Urinary levels of 11 dh-TxB2 pg/dl
|
Baseline and 12 months
|
Death due to cardiovascular disease
Tijdsspanne: Baseline and 12 months
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Rate of death due to cardiovascular disease.
|
Baseline and 12 months
|
Hospitalization due to cardiovascular disease
Tijdsspanne: Baseline and 12 months
|
Rate of hospitalization due to cardiovascular disease.
|
Baseline and 12 months
|
Death due to non-cardiovascular disease
Tijdsspanne: Baseline and 12 months
|
Rate of death due to non-cardiovascular disease.
|
Baseline and 12 months
|
Hospitalization due to non-cardiovascular disease
Tijdsspanne: Baseline and 12 months
|
Rate of hospitalizations due to non-cardiovascular disease.
|
Baseline and 12 months
|
Adverse events
Tijdsspanne: Baseline and 12 months
|
Traffic accidents and injuries while reading SMS related to the trial.
(Percentage)
|
Baseline and 12 months
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Juan P Casas, PhD, University College, London
- Studie stoel: Pablo A Perel, PhD, London School of Hygiene and Tropical Medicine
- Studie directeur: Norma C Serrano, MsC, Fundacion Cardiovascular de Colombia
- Hoofdonderzoeker: Anderson Bermon, MsC, Fundacion Cardiovascular de Colombia
- Hoofdonderzoeker: Ana F Uribe, PhD, Universidad Pontificia Bolivariana
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
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