Plain English Summary
Background and study aims
Diabetes is a condition that causes high blood sugar levels over a prolonged period. Type 2 diabetes mellitus (T2DM) begins with insulin resistance, a condition in which cells fail to respond to insulin properly. The most common cause is excessive body weight and insufficient exercise. The prevalence of T2DM has been becoming a global health problem. China has a fairly large proportion (approximately 25%) of diabetes patients in the worldwide. In China, the prevalence of diabetes has increased by 9.7%, which was accounted for 92.4 million adults. The direct economic burden of diabetes had increased in China in the past decades and the direct medical cost had reached to $9.1 billion. People with diabetes need to learn and maintain lifelong self-management behaviors, such as self-care activities associated to health care and daily life. Studies show that effective patient education might provide adequate information, support and monitoring that contribute to improve patients’ adherence, which in turn, decreases the burden of diabetes chronic complications and improving the quality of life for diabetes patients. Wechat had become the most popular messaging communication app in China, which had a monthly-active-user of 549 million. Wechat platform has been implicated to solve the problems of prehospital electrocardiogram remote transmission and prehospital clinical data recording for ST-segment elevation myocardial infarction care. The aim of this study is to assess the effectiveness of health education on diabetes patients via Wechat platform on increased the basic self-care skills in patients with type 2 diabetes.
Who can participate?
Adults aged 18 to 60 years old who are diagnosed with T2DM.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the usual care. Those in the second group receive the health education via the Wechat platform plus the usual care. Participants are followed up with blood tests and questionnaires to measure their insulin levels and self-efficacy abilities at six and 12 months.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in adhering to a healthier lifestyle. Participants may experience discomfort when providing blood tests.
Where is the study run from?
The Second Affiliated Hospital of Hainan Medical University (China)
When is the study starting and how long is it expected to run for?
June 2015 to June 2019
Who is funding the study?
The Second Affiliated Hospital of Hainan Medical University (China)
Who is the main contact?
Mr Yonghui Dong
Trial website
Contact information
Type
Public
Primary contact
Mr Yonghui Dong
ORCID ID
http://orcid.org/0000-0002-0534-3868
Contact details
Department of Orthopedics
Henan Provincial People's Hospital
Henan
Zhengzhou
450003
China
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Text message elevated awareness of self-care activities and glycemic control rate via Wechat among diabetes patient
Acronym
Study hypothesis
Positive effectiveness of health education on diabetes patients via Wechat platform on increased the basic self-care skills in patients with type 2 diabetes.
Ethics approval
the Second Affiliated Hospital of Hainan Medical University, 02/10/2015, ref: 2015-037
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Diabetes
Intervention
Diabetic patients are randomly classified to either the control (n=60) and intervention (n=60) group by using a set of 120 random numbers, according to 1:1 ratio.
The hospitalised patients of intervention(n=60) group receive conventional health education and nursing care for diabetes and are also guided by the Wechat platform.
The participants of control group receive conventional health education and nursing care for diabetes alone.
The baseline information on social and demographic characteristics (including age, gender, and educational attainment level), personal medical and lifestyle (such as active physical activity) are collected by trained nurse of our department using the questionnaires. Self-care activities are assessed according to a self-administered scale which is consisted of 21 diabetic items and divide into six self-management behaviors (general and specific diet, medication taking, exercise, blood sugar testing, foot care, and smoking). The diabetes self-care activities are asked diabetic individuals during past seven days. If individuals are sick during past seven days, they are asked to recall seven days that they not sick. Nonsmokers scored 0, smokers scored 1; Score was calculated by individuals spend days during past seven day on question of exercise, medication, monitoring of BG score, foot care relative items. If they spent 0, 1, 2, 3, 4, 5, 6 or 7 days on the questions of self-care activities, they scored 0, 1, 2, 3, 4, 5, 6 or 7. Additionally, other related to self-care recommendations from health care professionals’ items are also included. Participants are followed up at six and 12 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. HbA1c concentration is measured using the blood samples at six and 12 months
2. Self-Efficacy is measured using the Diabetes Management Self-Efficacy Scale questionnaire at six and 12 months
Secondary outcome measures
FPG and 2hPG is measured using blood samples at six and 12 months
Overall trial start date
05/06/2015
Overall trial end date
01/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. They were diagnosed type 2 diabetes by physicians according to World Health Organization (WHO) criteria
2. Aged 18-60 years
3. Possessed a mobile phone
4. Consented to receive text messages
5. Have the ability to read text messages
6. Voluntarily to participate in this study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Diagnosed type 1 diabetes
2. Specific diabetes
3. history of serious diseases such as renal or hepatic insufficiency
4. Severe visual impairment
5. Psychiatric diseases
6. Other endocrine diseases
Recruitment start date
12/01/2017
Recruitment end date
01/06/2017
Locations
Countries of recruitment
China
Trial participating centre
The Second Affiliated Hospital of Hainan Medical University
Henan
570311
China
Sponsor information
Organisation
Henan Provincial People's Hospital
Sponsor details
Zhengzhou 450003
Henan
Zhengzhou
450003
China
+86 18062559875
dongyonghuitjmu@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
The Second Affiliated Hospital of Hainan Medical University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/01/2019
Participant level data
Other
Basic results (scientific)
Publication list