Cardiovascular Health and Texting Messaging (CHAT) Study

NCT02888769 | Completed

• 1 other identifier: 201502009-1
• Study Type: interventional
• Target: 822
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Text messages; Blood pressure; Lifestyle; Risk factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in proportion of patients achieving a SBP<140mm Hg

  Baseline; 6months

• Change in low-density lipoprotein cholesterol (LDL-C) level

  Baseline; 6months

• Change in body mass index (BMI)

  Baseline; 6months

• Change in medication adherence

  Baseline; 6months

• Change in level of physical activity measured via International Physical Activity Questionnaire (IPAQ) scale

  Baseline; 6months

Study Arms (2)

Intervention-Text messaging

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in the control group will receive 2 thank-you messages per month and undertake routine clinical practice.

Interventions

Text Messaging BEHAVIORAL

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.

Intervention-Text messaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with coronary artery disease defined as history of myocardial infarction and percutaneous coronary intervention (PCI)
• Capability to read and send text messages

You may not qualify if:

• History of diabetes
• Assumed poor adherence
• Do not have an active mobile phone

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, China

Location

Related Publications (2)

• 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.

  PMID: 30998400 DERIVED

• 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.

  PMID: 29273661 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lixin Jiang, MD, PhD

  China National Center for Cardiovascular Disease

  PRINCIPAL INVESTIGATOR

• Harlan M Krumholz, MD, SM

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 5, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

CN (1)