Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes
NCT ID: NCT05629117
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2022-12-26
2023-07-30
Brief Summary
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Detailed Description
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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:
This study is an assessor-blinded, three-arm, parallel randomized controlled trial (RCT). 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education Group
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). Additionally they will receive peer support education weekly during three month.
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
Personalized Diabetes Text Messaging (DB-TEXT) Group
The participants in the Personalized DB-TEXT group will receive the personalized short text message twice weekly at approximately noon on Monday and Thursday for three months (12 weeks).
Personalized Diabetes Text Messaging (DB-TEXT)
Personalized Diabetes Text Messaging (DB-TEXT)
Control Group
Health education related to diabetes management will be provided to the control group once a month during three months
No interventions assigned to this group
Interventions
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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
Personalized Diabetes Text Messaging (DB-TEXT)
Personalized Diabetes Text Messaging (DB-TEXT)
Eligibility Criteria
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Inclusion Criteria
* Participants ho were 17 years or older (the legal age to provide informed consent in Indonesia)
* having their own mobile phone
Exclusion Criteria
* Had medical diagnostic with cognitive impairments
* Psychiatric disorders, or were diagnosed with cancer
17 Years
ALL
No
Sponsors
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Taipei Medical University
OTHER
Responsible Party
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Hsiao-Yean Chiu
Principal Investigator
Locations
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Taipei Medical University
Taipei, Xinyi District, Taiwan
Countries
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Other Identifiers
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No.1738/UN25.8/KEPK/DL/2022
Identifier Type: -
Identifier Source: org_study_id
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