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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-26

Study Completion Date

2023-07-30

Brief Summary

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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

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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:

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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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education

Intervention Type BEHAVIORAL

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).

Group Type ACTIVE_COMPARATOR

Personalized Diabetes Text Messaging (DB-TEXT)

Intervention Type BEHAVIORAL

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

Group Type NO_INTERVENTION

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

Intervention Type BEHAVIORAL

Personalized Diabetes Text Messaging (DB-TEXT)

Personalized Diabetes Text Messaging (DB-TEXT)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hsiao-Yean Chiu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei Medical University

Taipei, Xinyi District, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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No.1738/UN25.8/KEPK/DL/2022

Identifier Type: -

Identifier Source: org_study_id

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