Clinical trial NCT03724526: Text Messaging and Cardiovascular Health in Diabetes Mellitus
Official title: Text Messaging and Cardiovascular Health in Diabetes Mellitus: A Randomized, Controlled Clinical Trial (TEACH Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
cardiovascular disease
text message
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 819
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model.
timeFrame: 12 months
Secondary outcomes:
measure: Change in glucose level measured by HbA1C level
timeFrame: 12 months
measure: Change in Systolic blood pressure level
timeFrame: 12 months
measure: Change in LDL-cholesterol level
timeFrame: 12 months
measure: The proportion achieving levels of Hba1c < 7% (< 7.5% if combined with cardiovascular disease)
timeFrame: 12 months
measure: The proportion achieving levels of blood pressure <140/90 mm Hg
timeFrame: 12 months
measure: The proportion achieving levels of LDL-cholesterol <100 mg/dL
timeFrame: 12 months
measure: Change in Framingham Risk Score
timeFrame: 12 months
measure: Change in ACC/AHA Risk Score of CVD
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Huijie Zhang, M.D.&Ph.D
role: PRINCIPAL_INVESTIGATOR
References: