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

Text Messaging and Cardiovascular Health in Diabetes Mellitus

Sponsors

Lead sponsor: Nanfang Hospital of Southern Medical University

Source Nanfang Hospital of Southern Medical University
Brief Summary

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

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.

Overall Status Recruiting
Start Date November 1, 2018
Completion Date March 2021
Primary Completion Date March 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. 12 months
Secondary Outcome
Measure 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
Enrollment 800
Condition
Intervention

Intervention type: Behavioral

Intervention name: Text messaging

Description: 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.

Arm group label: Intervention-Text messaging

Eligibility

Criteria:

Inclusion Criteria:

1. Male and female patients aged 18 years and over

2. 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)

3. Participants can provide written informed consent.

4. Participants required access to a smartphone, and be able to receive and read text message.

Exclusion Criteria:

1. Participants were in functional New York Heart Association class III or IV, and were on haemodialysis;

2. Pregnant women or women planning to become pregnant

3. Participants cannot be followed up for 12 months (due to health status or migration)

4. Participants cannot provide written informed consent.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Huijie Zhang, M.D.&Ph.D Principal Investigator Nanfang Hospital of Southern Medical University
Overall Contact

Last name: Huijie Zhang, M.D.&Ph.D

Phone: +86-020-61641635

Email: Huijiez[email protected]

Location
facility status contact contact_backup
Nanfang Hospital of Southern Medical University Recruiting Huijie Zhang, MD,PhD +86-020-61641635 [email protected]
Location Countries

China

Verification Date

February 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Nanfang Hospital of Southern Medical University

Investigator full name: Huijie Zhang

Investigator title: Clinical Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Intervention-Text messaging

Arm group type: Experimental

Description: 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.

Arm group label: Control

Arm group type: No Intervention

Description: Participates in control group will not receive text messages.

Acronym TEACH
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention 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.

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: The study is a two-arm, parallel, randomized clinical trial. The primary outcome and secondary outcomes was measured by blinded assessors throughout the study period.

Source: ClinicalTrials.gov