Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, cardiovascular disease, text message
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.
Interventions
BEHAVIORALText 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in glucose level measured by HbA1C level | 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 |
| The proportion achieving levels of blood pressure <140/90 mm Hg | 12 months |
Countries
China
Outcome results
None listed