Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes
NCT05629117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2023-08-04
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.
Conditions
Interventions
- BEHAVIORAL
-
Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education
Patients who are assigned to the DB-TEXT+PSE group will receive personalized short text message services twice weekly at approximately noon on Monday and Thursday for three months (12 weeks). Furthermore, they will receive the peer support education weekly from the peer supporter by telephone during three months
- BEHAVIORAL
-
Personalized Diabetes Text Messaging (DB-TEXT)
Personalized Diabetes Text Messaging (DB-TEXT)
Sponsors & Collaborators
-
Taipei Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-26
- Primary Completion
- 2023-07-30
- Completion
- 2023-07-30
Countries
- Taiwan
Study Locations
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