Text Messaging and Cardiovascular Health in Diabetes Mellitus

NCT ID: NCT03724526

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 819 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2022-07-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention-Text messaging

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.

Group Type: EXPERIMENTAL

Text messaging

Intervention Type: BEHAVIORAL

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.

Control

Participates in control group will not receive text messages.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text messaging

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Huijie Zhang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huijie Zhang, M.D.&Ph.D

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Countries

China

References

Zhang PZ, Guo D, Liu CQ, Chen N, Liu JF, Lei XZ, Yang LJ, Liu YT, Li X, Huang JF, Du CM, Wang K, Mo W, Lin JY, Huang CS, Xu BY, Wei XY, Liu DY, Huang JL, Huang Y, Xue YM, Zeng YM, Liu SQ, Ma ZM, Zhang HJ. Mobile App-Based Intervention and Cardiovascular Risk Factors in Patients With Uncontrolled Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529762. doi: 10.1001/jamanetworkopen.2025.29762.

Reference Type: DERIVED

PMID: 40892411 (View on PubMed)

Other Identifiers

NFEC-2018-117

Identifier Type: -

Identifier Source: org_study_id