Clinical trial NCT02883842: Cardiovascular Health and Text Messaging-Diabetes Mellitus (CHAT-DM) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Diabetes
Keywords: Coronary artery disease
Diabetes
Text messages
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2016-08-30
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in glucose level measured by HbA1C level
timeFrame: Baseline; 6 months
Secondary outcomes:
measure: Change in proportion of patients achieving HbA1C<7%
timeFrame: Baseline; 6 months
measure: Change in level of fasting blood glucose (FBG)
timeFrame: Baseline; 6 months
measure: Change in body mass index (BMI) according to national standards
timeFrame: Baseline; 6 months
measure: Change in systolic blood pressure (SBP) obtained in office during each interview
timeFrame: Baseline; 6 months
measure: Change in level of physical activity measured via International Physical Activity Questionnaire (IPAQ) scale
timeFrame: Baseline; 6 months
measure: Change in medication adherence
timeFrame: Baseline; 6 months
measure: Change in low-density lipoprotein cholesterol (LDL-C) level
timeFrame: Baseline; 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Disease
name: Lixin Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Harlan M Krumholz, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.