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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Santander
-
Floridablanca, Santander, Kolumbien, 683071
- Fundacion Cardiovascular de Colombia
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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-Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol
Zeitfenster: 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
Zeitfenster: Baseline and 12 months
|
Systolic Blood pressure mmHg
|
Baseline and 12 months
|
|
Differences in physiological variables depending on taking medications: Heart Rate
Zeitfenster: Baseline and 12 months
|
Heart Rate: Heartbeats per minute
|
Baseline and 12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in self-reported adherence and recurrence of new cardiovascular and adverse events.
Zeitfenster: 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
Zeitfenster: Baseline and 12 months
|
Changes in Urinary levels of 11 dh-TxB2 pg/dl
|
Baseline and 12 months
|
|
Death due to cardiovascular disease
Zeitfenster: Baseline and 12 months
|
Rate of death due to cardiovascular disease.
|
Baseline and 12 months
|
|
Hospitalization due to cardiovascular disease
Zeitfenster: Baseline and 12 months
|
Rate of hospitalization due to cardiovascular disease.
|
Baseline and 12 months
|
|
Death due to non-cardiovascular disease
Zeitfenster: Baseline and 12 months
|
Rate of death due to non-cardiovascular disease.
|
Baseline and 12 months
|
|
Hospitalization due to non-cardiovascular disease
Zeitfenster: Baseline and 12 months
|
Rate of hospitalizations due to non-cardiovascular disease.
|
Baseline and 12 months
|
|
Adverse events
Zeitfenster: Baseline and 12 months
|
Traffic accidents and injuries while reading SMS related to the trial.
(Percentage)
|
Baseline and 12 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Juan P Casas, PhD, University College, London
- Studienstuhl: Pablo A Perel, PhD, London School of Hygiene and Tropical Medicine
- Studienleiter: Norma C Serrano, MsC, Fundacion Cardiovascular de Colombia
- Hauptermittler: Anderson Bermon, MsC, Fundacion Cardiovascular de Colombia
- Hauptermittler: Ana F Uribe, PhD, Universidad Pontificia Bolivariana
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 416
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Intervention SMS
-
Washington University School of MedicineAbgeschlossenFettleibigkeit | Übergewicht | Schwere psychische StörungVereinigte Staaten
-
University of Massachusetts, WorcesterNational Institute of Mental Health (NIMH); Yale University; Worcester Polytechnic... und andere MitarbeiterAbgeschlossenEpisode einer Major DepressionVereinigte Staaten
-
Massachusetts General HospitalAbgeschlossenHypertonie | Typ 2 Diabetes | HyperlipämieVereinigte Staaten
-
University of RochesterNational Cancer Institute (NCI)AbgeschlossenGebärmutterhalskrebsVereinigte Staaten
-
University of WashingtonJohn L. Locke Jr. Charitable TrustBeendetHerzinfarkt | Perkutane Koronarintervention | Koronararterien-Bypass-Operation | Chronisch stabile Angina | Linksventrikuläres Unterstützungssystem | Herz Transplantation | Chronisch stabile Herzinsuffizienz | Herzklappenreparatur oder -ersatzVereinigte Staaten
-
University of PennsylvaniaBenefits Data TrustAbgeschlossenSoziale Determinanten von GesundheitVereinigte Staaten
-
Jonsson Comprehensive Cancer CenterZurückgezogenÜberlebende von Krebs im KindesalterVereinigte Staaten
-
Central South UniversityAbgeschlossenNicht selbstmörderische SelbstverletzungChina
-
Samanta Winck MadrugaUnbekanntKrebs | NebenwirkungBrasilien
-
NYU Langone HealthNational Institute on Minority Health and Health Disparities (NIMHD)AbgeschlossenTyp 2 DiabetesVereinigte Staaten