Cardiovascular Health and Text Messaging-Diabetes Mellitus (CHAT-DM) Study

NCT02883842 | Completed

• 1 other identifier: 201502009-2
• Study Type: interventional
• Target: 502
• 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 with 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; Diabetes

Keywords

Coronary artery disease; Diabetes; Text messages

Outcome Measures

Primary Outcomes (1)

• Change in glucose level measured by HbA1C level

  We will measured the change in glucose level from baseline to 6 months.

  Baseline; 6 months

Secondary Outcomes (7)

• Change in proportion of patients achieving HbA1C<7%

  Baseline; 6 months

• Change in level of fasting blood glucose (FBG)

  Baseline; 6 months

• Change in body mass index (BMI) according to national standards

  Baseline; 6 months

• Change in systolic blood pressure (SBP) obtained in office during each interview

  Baseline; 6 months

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

  Baseline; 6 months

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). They will receive one general messages, one hypertension message, one glucose control message, one lifestyle message, one medication adherence message and one physical activity 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). They will receive one general messages, one hypertension message, one glucose control message, one lifestyle message, one medication adherence message and one physical activity message per week. Prior to study commencement, a bank of 270 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 PCI
• History of diabetes
• Capability to read and send text messages

You may not qualify if:

• 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)

• Huo X, Krumholz HM, Bai X, Spatz ES, Ding Q, Horak P, Zhao W, Gong Q, Zhang H, Yan X, Sun Y, Liu J, Wu X, Guan W, Wang X, Li J, Li X, Spertus JA, Masoudi FA, Zheng X. Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus: A Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Sep;12(9):e005805. doi: 10.1161/CIRCOUTCOMES.119.005805. Epub 2019 Aug 31.

  PMID: 31474119 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; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System 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 24, 2016
• First Posted: August 30, 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)