Text Messaging and Cardiovascular Health in Diabetes Mellitus

NCT03724526 | Completed

• 1 other identifier: NFEC-2018-117
• Study Type: interventional
• Target: 819
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus; cardiovascular disease; text message

Outcome Measures

Primary Outcomes (1)

• Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model.

  12 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Intervention-Text messaging

EXPERIMENTAL

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

Control

NO INTERVENTION

Participates in control group will not receive text messages.

Interventions

Text messaging 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.

Intervention-Text messaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

• 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.

  PMID: 40892411 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Huijie Zhang, M.D.&Ph.D

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 30, 2018
• Study Start: November 1, 2018
• Primary Completion: June 22, 2022
• Study Completion: July 30, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)