- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03098186
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
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Santander
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Floridablanca, Santander, 콜롬비아, 683071
- Fundacion Cardiovascular de Colombia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Intervention SMS
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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.
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위약 비교기: Control SMS
SMS to thanks for participation in the trial and reminders of trial appointments.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol
기간: Baseline and 12 months
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Low density lipoprotein cholesterol (LDL-C) mg/dl
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Baseline and 12 months
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Differences in physiological variables depending on taking medications: Systolic Blood pressure
기간: Baseline and 12 months
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Systolic Blood pressure mmHg
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Baseline and 12 months
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Differences in physiological variables depending on taking medications: Heart Rate
기간: Baseline and 12 months
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Heart Rate: Heartbeats per minute
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Baseline and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Changes in self-reported adherence and recurrence of new cardiovascular and adverse events.
기간: Baseline and 12 months
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Adherence to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire
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Baseline and 12 months
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Urinary levels of 11 dh-TxB2
기간: Baseline and 12 months
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Changes in Urinary levels of 11 dh-TxB2 pg/dl
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Baseline and 12 months
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Death due to cardiovascular disease
기간: Baseline and 12 months
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Rate of death due to cardiovascular disease.
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Baseline and 12 months
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Hospitalization due to cardiovascular disease
기간: Baseline and 12 months
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Rate of hospitalization due to cardiovascular disease.
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Baseline and 12 months
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Death due to non-cardiovascular disease
기간: Baseline and 12 months
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Rate of death due to non-cardiovascular disease.
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Baseline and 12 months
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Hospitalization due to non-cardiovascular disease
기간: Baseline and 12 months
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Rate of hospitalizations due to non-cardiovascular disease.
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Baseline and 12 months
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Adverse events
기간: Baseline and 12 months
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Traffic accidents and injuries while reading SMS related to the trial.
(Percentage)
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Baseline and 12 months
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Juan P Casas, PhD, University College, London
- 연구 의자: Pablo A Perel, PhD, London School of Hygiene and Tropical Medicine
- 연구 책임자: Norma C Serrano, MsC, Fundacion Cardiovascular de Colombia
- 수석 연구원: Anderson Bermon, MsC, Fundacion Cardiovascular de Colombia
- 수석 연구원: Ana F Uribe, PhD, Universidad Pontificia Bolivariana
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Intervention SMS에 대한 임상 시험
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University of PittsburghUniversity of Pennsylvania완전한
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University of MichiganUniversidad de Los Andes, Bogota, Colombia완전한
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