Cardiovascular Health and Texting Messaging (CHAT) Study
Effectiveness of Text Messaging on Risk Factors Control and Medication Adherence Among Coronary Heart Disease Patients Without Diabetes in Cardiovascular Health and Texting Messaging (CHAT) Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Objective: This study aims to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention, including lifestyles modification, medication adherence improvement and risk factors control among CHD patients without diabetes. We hypothesized that an intervention using mobile phone text based education and reminder can improve risk factors control and medication adherence for CHD patients.
Study design: The study is a two-arm, parallel, randomized clinical trial. Patients will be eligible if they have documented CHD defined as having history of myocardial infarction and PCI but without diabetes mellitus, have the capability of reading and sending short message, and are able to provide informed consent. Patients who do not have an active mobile phone will be excluded. The eligible participants will be allocated into intervention and control groups in a 1:1 ratio randomly. The intervention group will receive intervention of pre-designed text messages in addition to usual care, while the control group will receive usual care. All the participants will be followed up for 6 months.
Study intervention: Participants in the intervention group will receive semi-personalized text messages for 6 months as well as usual care. Non-smokers will receive two general messages, two hypertension messages, one medication adherence message and one physical activity message per week. Smokers will receive one general message, two hypertension messages, one medication adherence message, one physical activity message and one smoking cessation message per week.
Outcome measures: The primary endpoint is systolic blood pressure control. Secondary endpoints include a change in proportion of patients achieving a systolic blood pressure<140mm Hg, physical activity, medication adherence, smoking cessation, low-density lipoprotein cholesterol (LDL-C) and body mass index (BMI). Exploratory endpoints include long-term prognosis of the patients, such as death, non-fatal myocardial infarction, stroke and so on, as well as health status (SAQ and EQ-5D).
Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine
- Fuwai Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participants with coronary artery disease defined as history of myocardial infarction and percutaneous coronary intervention (PCI)
- Capability to read and send text messages
Exclusion Criteria:
- History of diabetes
- Assumed poor adherence
- Do not have an active mobile phone
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Contrôle
Les participants du groupe témoin recevront 2 messages de remerciement par mois et entreprendront une pratique clinique de routine.
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Expérimental: Intervention-Text messaging
Patients will receive regular semi-personalized text messages for 6 months.
Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am,
12noon, 4.00pm).
Non-smokers will receive two general messages, two hypertension messages, one medication adherence message and one physical activity message per week.
Smokers will receive one general message, two hypertension messages, one medication adherence message, one physical activity message and one smoking cessation message per week.
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Patients will receive regular semi-personalized text messages for 6 months.
Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am,
12noon, 4.00pm).
Non-smokers will receive two general messages, two hypertension messages, one medication adherence message and one physical activity message per week.
Smokers will receive one general message, two hypertension messages, one medication adherence message, one physical activity message and one smoking cessation message per week.
Prior to study commencement, a bank of 280 messages have been developed based on guidelines and behavior change theory (BCT), and have underwent multidisciplinary expert review and qualitative review process.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in systolic blood pressure obtained in office during each interview
Délai: Baseline; 6months
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The investigators will measure the change in systolic blood pressure from baseline to 6 months.
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Baseline; 6months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in proportion of patients achieving a SBP<140mm Hg
Délai: Baseline; 6months
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The investigators will measure the proportion of patients achieving a SBP<140mm Hg from baseline to 6 months.
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Baseline; 6months
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Change in low-density lipoprotein cholesterol (LDL-C) level
Délai: Baseline; 6months
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The investigators will measure the change in LDL-C level from baseline to 6 months.
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Baseline; 6months
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Change in body mass index (BMI)
Délai: Baseline; 6months
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The investigators will measure the change in BMI from baseline to 6 months.
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Baseline; 6months
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Change in medication adherence
Délai: Baseline; 6months
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The investigators will measure the change in medication adherence from baseline to 6 months.
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Baseline; 6months
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Change in level of physical activity measured via International Physical Activity Questionnaire (IPAQ) scale
Délai: Baseline; 6months
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The investigators will measure the change in IPAQ scale from baseline to 6 months.
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Baseline; 6months
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Change in proportion of non-smokers
Délai: Baseline; 6months
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The investigators will measure the proportion of non-smokers via self report and cotinine urine strip test from baseline to 6 months.
The patients who report as non-smokers with negative cotinine test result will be defined as non-smokers.
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Baseline; 6months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Harlan M Krumholz, MD, SM, Yale University
- Chercheur principal: Lixin Jiang, MD, PhD, China National Center for Cardiovascular Disease
Publications et liens utiles
Publications générales
- Huo X, Spatz ES, Ding Q, Horak P, Zheng X, Masters C, Zhang H, Irwin ML, Yan X, Guan W, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM, Jiang L. Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes. BMJ Open. 2017 Dec 21;7(12):e018302. doi: 10.1136/bmjopen-2017-018302. Erratum In: BMJ Open. 2018 Jan 21;8(1):e018302corr1.
- Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201502009-1
Plan pour les données individuelles des participants (IPD)
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