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

May 7, 2018 updated by: China National Center for Cardiovascular Diseases

Effectiveness of Text Messaging on Risk Factors Control and Medication Adherence Among Patients With Coronary Heart Disease and Diabetes in China: Cardiovascular Health and Text Messaging-Diabetes Mellitus (CHAT-DM) 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 with 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 percutaneous coronary intervention (PCI), have a history of diabetes mellitus, have the capability of reading and sending short message, and are able to provide informed consent. Patients will be excluded if they do not have an active mobile phone. 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 text messages for 6 months as well as usual care. 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.

Outcome measures: The primary endpoint is the change in glycemic hemoglobin (HbA1C) as measured by central blood sample. Secondary endpoints include a change in proportion of patients achieving HbA1C<7%, body mass index (BMI), physical activity, medication adherence, systolic blood pressure, low-density lipoprotein cholesterol (LDL-C) and fasting blood glucose (FBG). Exploratory endpoints include long-term prognosis of the patients, such as death, nonfatal 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)

502

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 PCI
  • History of diabetes
  • Capability to read and send text messages

Exclusion Criteria:

  • Assumed poor adherence
  • Do not have an active mobile phone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glucose level measured by HbA1C level
Time Frame: Baseline; 6 months
We will measured the change in glucose level from baseline to 6 months.
Baseline; 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proportion of patients achieving HbA1C<7%
Time Frame: Baseline; 6 months
We will measure the change in proportion of patients achieving HbA1C<7% from baseline to 6 months.
Baseline; 6 months
Change in level of fasting blood glucose (FBG)
Time Frame: Baseline; 6 months
We will measure the change in FBG level from baseline to 6 months.
Baseline; 6 months
Change in body mass index (BMI) according to national standards
Time Frame: Baseline; 6 months
We will measured the change in BMI from baseline to 6 months.
Baseline; 6 months
Change in systolic blood pressure (SBP) obtained in office during each interview
Time Frame: Baseline; 6 months
We will measured the change in SBP from baseline to 6 months.
Baseline; 6 months
Change in level of physical activity measured via International Physical Activity Questionnaire (IPAQ) scale
Time Frame: Baseline; 6 months
We will measure the change in IPAQ scale from baseline to 6 months.
Baseline; 6 months
Change in medication adherence
Time Frame: Baseline; 6 months
We will measure the change in medication adherence from baseline to 6 months.
Baseline; 6 months
Change in low-density lipoprotein cholesterol (LDL-C) level
Time Frame: Baseline; 6 months
We will measure the change in LDL-C level from baseline to 6 months.
Baseline; 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 24, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201502009-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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