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

The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is 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 coronary heart disease (CHD) patients without diabetes. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 6 pre-designed text messages per week in addition to usual care for 6 months, while the control group will receive usual care.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Text Messaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 822
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants in the control group will receive 2 thank-you messages per month and undertake routine clinical practice.
Experimental: 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.	Behavioral: 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure obtained in office during each interview	The investigators will measure the change in systolic blood pressure from baseline to 6 months.	Baseline; 6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proportion of patients achieving a SBP<140mm Hg	The investigators will measure the proportion of patients achieving a SBP<140mm Hg from baseline to 6 months.	Baseline; 6months
Change in low-density lipoprotein cholesterol (LDL-C) level	The investigators will measure the change in LDL-C level from baseline to 6 months.	Baseline; 6months
Change in body mass index (BMI)	The investigators will measure the change in BMI from baseline to 6 months.	Baseline; 6months
Change in medication adherence	The investigators will measure the change in medication adherence from baseline to 6 months.	Baseline; 6months
Change in level of physical activity measured via International Physical Activity Questionnaire (IPAQ) scale	The investigators will measure the change in IPAQ scale from baseline to 6 months.	Baseline; 6months
Change in proportion of non-smokers	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.	Baseline; 6months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Harlan M Krumholz, MD, SM, Yale University; Principal Investigator: Lixin Jiang, MD, PhD, China National Center for Cardiovascular Disease

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Coronary artery disease; Blood pressure; Risk factors; Text messages; Lifestyle
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 201502009-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED