The Effects of Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Taipei Medical University
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- Changes in fasting blood glucose level
Study Overview
Brief Summary
The purpose of this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes. This study is an assessor-blinded, three-arm, parallel randomized controlled trial. Additionally, the investigators will use the CONSORT guidelines to report of trial finding. A diabetes management centers in East Java Province will be recruited for the participants from December 2022 to March 2023. The investigators will include participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months), and who were 17 years or older (the legal age to provide informed consent in Indonesia) and having their own mobile phone. People who could not read or write Indonesian; had medical diagnostic with cognitive impairments, psychiatric disorders, or were diagnosed with cancer before the study will be excluded from the study. The outcomes of the study including demographic and disease characteristic, clinical outcomes, fatigue, sleep quality, depression, and quality of life. For the clinical outcomes, will be measured in laboratory test in diabetes management centers. Fatigue level will be measured using the Multidimensional Fatigue Inventory-20 (MFI-20), sleep quality will be measured using a Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory-Second Edition (BDI-II) will be used to measure the depression level, and the Diabetes Quality of Life-Brief Clinical Inventory (The DQoL-BCI) will be used to assess the quality of life.
Detailed Description
Background :
Our early component network meta-analysis (CNMA) study showed that short message service (SMS) and peer support education (PSE) are the most effective component of digitally assisted intervention in improving HbA1C level in type 2 diabetes.
Purposes:
The purpose of this study to investigate the effects of personalized diabetes text messaging (DB-TEXT) combined with PSE in patients with type 2 diabetes.
Methods:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants who had been diagnosed with poorly controlled type 2 diabetes (having HbA1C level of > 7% in the past three months)
- •Participants ho were 17 years or older (the legal age to provide informed consent in Indonesia)
- •having their own mobile phone
Exclusion Criteria
- •People who could not read or write Indonesian
- •Had medical diagnostic with cognitive impairments
- •Psychiatric disorders, or were diagnosed with cancer
Outcomes
Primary Outcomes
Changes in fasting blood glucose level
Time Frame: at baseline, 3 months, 6 months
Fasting blood glucose level of participants will be assessed using glucometer
Changes in Lipids level including total cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) , and triglycerides
Time Frame: at baseline, 3 months, 6 months
The total cholesterol, LDL, HDL, and triglycerides of the participants will assessed in the laboratory test in hospital
Changes in Blood Pressure Level including Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Time Frame: at baseline, 3 months, 6 months
Blood pressure of participants will be measured using sphygmomanometer
Changes in HbA1C level
Time Frame: at baseline, 3 months, 6 months
HbA1C level of participants will be assessed in the laboratory test in hospital
Secondary Outcomes
- Changes in Quality of Life(At baseline, 3 months, 6 months)
- Changes in Fatigue(At baseline, 3 months, 6 months)
- Changes in Depression(At baseline, 3 months, 6 months)
- Changes in Sleep Quality(At baseline, 3 months, 6 months)
Investigators
Hsiao-Yean Chiu
Principal Investigator
Taipei Medical University