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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 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

930

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundación Cardiovascular de Colombia

Samarbejdspartnere

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

Efterforskere

  • 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
  • Ledende efterforsker: Anderson Bermon, MsC, Fundacion Cardiovascular de Colombia
  • Ledende efterforsker: Ana F Uribe, PhD, Universidad Pontificia Bolivariana

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. april 2017

Primær færdiggørelse (Faktiske)

19. august 2019

Studieafslutning (Faktiske)

19. august 2019

Datoer for studieregistrering

Først indsendt

10. marts 2017

Først indsendt, der opfyldte QC-kriterier

30. marts 2017

Først opslået (Faktiske)

31. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 416

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Kliniske forsøg med Kardiovaskulær sygdom

Kliniske forsøg med Intervention SMS

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