Text Messaging and Cardiovascular Health in Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of the study of the proposed randomized trial is to evaluate the effectiveness of automated mobile phone text message-based intervention in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes.

Detailed Description
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Most patients with diabetes have multiple risk factors, such as obesity, hypertension, and dyslipidemia, or with arteriosclerotic cardiovascular disease (ASCVD). The purpose of the study of the proposed randomized trial will examine the effect of health text messages in improving lifestyle modification, medication adherence and CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 12 months among patients with type 2 diabetes. This study is a multicenter prospective, randomized, controlled clinical trial. The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care. The messages will target lifestyle recommendation, glucose control, blood pressure control, healthy eating, medication adherence, physical activity and smoking cessation. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. The primary outcome is the combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. The Secondary outcome includes the net change of CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol), and the proportion of participants with HbA1C <7% (<7.5% if with clinical CVD), BP<140/90 mm Hg, and LDL-cholesterol <100 mg/dL, and net change in estimated 10-year risk of CHD and CVD. The primary outcome and secondary outcome will be measured at month 3, 6, and 12 visits.

Official Title
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Text Messaging and Cardiovascular Health in Diabetes Mellitus: A Randomized, Controlled Clinical Trial (TEACH Study)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Text messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 18 years and over Patients with poorly controlled type 2 diabetes who are undergoing routine treatment (defined as HbA1c≥ 7% or HbA1c≥7.5% if combined with clinical cardiovascular disease) have at least one risk factor for other cardiovascular disease (SBP≥140 mmHg and/or DBP≥90 mmHg and/or low density lipoprotein cholesterol≥100mg/dL) or clinical atherosclerotic cardiovascular disease (acute coronary syndrome, ischemic stroke transient ischemic attack or peripheral arterial disease) Participants can provide written informed consent. Participants required access to a smartphone, and be able to receive and read text message. Exclusion Criteria: Participants were in functional New York Heart Association class III or IV, and were on haemodialysis; Pregnant women or women planning to become pregnant Participants cannot be followed up for 12 months (due to health status or migration) Participants cannot provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The eligible participants will be randomly allocated into intervention and control groups in a 1:1 ratio. The intervention group will receive text messages in addition to usual care for 12 months, while the control group will receive usual care.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention-Text messaging<br>Participates will receive regular 6 text messages per week for 12 months. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week. Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours. | Behavioral: Text messaging<br>* Intervention-Text messaging: Participants will receive regular text messages for 12 months. Each participant will receive 6 text messages per week. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week. Control: The control group will receive the usual care.<br>|
| No Intervention: Control<br>Participates in control group will not receive text messages. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose level measured by HbA1C level |  | 12 months | 
| Change in Systolic blood pressure level |  | 12 months | 
| Change in LDL-cholesterol level |  | 12 months | 
| The proportion achieving levels of Hba1c < 7% (< 7.5% if combined with cardiovascular disease) |  | 12 months | 
| The proportion achieving levels of blood pressure <140/90 mm Hg |  | 12 months | 
| The proportion achieving levels of LDL-cholesterol <100 mg/dL |  | 12 months | 
| Change in Framingham Risk Score |  | 12 months | 
| Change in ACC/AHA Risk Score of CVD |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, cardiovascular disease, text message