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Text Messaging and Cardiovascular Health in Diabetes Mellitus (TEACH)

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ClinicalTrials.gov Identifier: NCT03724526
Recruitment Status : Active, not recruiting
First Posted : October 30, 2018
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Huijie Zhang, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Text messaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
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.
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.
Primary Purpose: Treatment
Official Title: Text Messaging and Cardiovascular Health in Diabetes Mellitus: A Randomized, Controlled Clinical Trial (TEACH Study)
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.


No Intervention: Control
Participates in control group will not receive text messages.



Primary Outcome Measures :
  1. Combined changes in HbA1C, SBP and LDL-cholesterol levels, simultaneous modeled using a scaled marginal model. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in glucose level measured by HbA1C level [ Time Frame: 12 months ]
  2. Change in Systolic blood pressure level [ Time Frame: 12 months ]
  3. Change in LDL-cholesterol level [ Time Frame: 12 months ]
  4. The proportion achieving levels of Hba1c < 7% (< 7.5% if combined with cardiovascular disease) [ Time Frame: 12 months ]
  5. The proportion achieving levels of blood pressure <140/90 mm Hg [ Time Frame: 12 months ]
  6. The proportion achieving levels of LDL-cholesterol <100 mg/dL [ Time Frame: 12 months ]
  7. Change in Framingham Risk Score [ Time Frame: 12 months ]
  8. Change in ACC/AHA Risk Score of CVD [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724526


Locations
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China, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Huijie Zhang, M.D.&Ph.D Nanfang Hospital of Southern Medical University
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Responsible Party: Huijie Zhang, Clinical Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03724526    
Other Study ID Numbers: NFEC-2018-117
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huijie Zhang, Nanfang Hospital of Southern Medical University:
Diabetes Mellitus
cardiovascular disease
text message
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases