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

4. juni 2020 oppdatert av: Fundación Cardiovascular de Colombia

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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

930

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Colombia
    • Santander
      • Floridablanca, Santander, Colombia, 683071
        • Fundacion cardiovascular de Colombia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Intervention SMS
  1. 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.
Atferdsmessig: 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.
Atferdsmessig: Control SMS
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol
Tidsramme: 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
Tidsramme: Baseline and 12 months
Systolic Blood pressure mmHg
Baseline and 12 months
Differences in physiological variables depending on taking medications: Heart Rate
Tidsramme: Baseline and 12 months
Heart Rate: Heartbeats per minute
Baseline and 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in self-reported adherence and recurrence of new cardiovascular and adverse events.
Tidsramme: 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
Tidsramme: Baseline and 12 months
Changes in Urinary levels of 11 dh-TxB2 pg/dl
Baseline and 12 months
Death due to cardiovascular disease
Tidsramme: Baseline and 12 months
Rate of death due to cardiovascular disease.
Baseline and 12 months
Hospitalization due to cardiovascular disease
Tidsramme: Baseline and 12 months
Rate of hospitalization due to cardiovascular disease.
Baseline and 12 months
Death due to non-cardiovascular disease
Tidsramme: Baseline and 12 months
Rate of death due to non-cardiovascular disease.
Baseline and 12 months
Hospitalization due to non-cardiovascular disease
Tidsramme: Baseline and 12 months
Rate of hospitalizations due to non-cardiovascular disease.
Baseline and 12 months
Adverse events
Tidsramme: Baseline and 12 months
Traffic accidents and injuries while reading SMS related to the trial. (Percentage)
Baseline and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fundación Cardiovascular de Colombia

Samarbeidspartnere

London School of Hygiene and Tropical Medicine
University College, London
Universidad Pontificia Bolivariana

Etterforskere

  • Studiestol: Juan P Casas, PhD, University College, London
  • Studiestol: Pablo A Perel, PhD, London School of Hygiene and Tropical Medicine
  • Studieleder: Norma C Serrano, MsC, Fundacion cardiovascular de Colombia
  • Hovedetterforsker: Anderson Bermon, MsC, Fundacion cardiovascular de Colombia
  • Hovedetterforsker: Ana F Uribe, PhD, Universidad Pontificia Bolivariana

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. april 2017

Primær fullføring (Faktiske)

19. august 2019

Studiet fullført (Faktiske)

19. august 2019

Datoer for studieregistrering

Først innsendt

10. mars 2017

Først innsendt som oppfylte QC-kriteriene

30. mars 2017

Først lagt ut (Faktiske)

31. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2020

Sist bekreftet

1. juni 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 416

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