Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes

August 2, 2023 updated by: Hsiao-Yean Chiu, Taipei Medical University

The Effects of Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Xinyi District
      • Taipei City, Xinyi District, Taiwan, 100
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Active Comparator: 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).
Behavioral: Personalized Diabetes Text Messaging (DB-TEXT)
Personalized Diabetes Text Messaging (DB-TEXT)
No Intervention: Control Group
Health education related to diabetes management will be provided to the control group once a month during three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline, 3 months, 6 months
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
at baseline, 3 months, 6 months
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
at baseline, 3 months, 6 months
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
at baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Fatigue
Time Frame: At baseline, 3 months, 6 months
Fatigue levels of participants will be assessed using a Multidimensional Fatigue Inventory-20 (MFI-20). MFI-20 contains 20 items and five subscales, general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.
At baseline, 3 months, 6 months
Changes in Sleep Quality
Time Frame: At baseline, 3 months, 6 months
Sleep quality of the participants will be measured using The Pittsburgh Sleep Quality Index (PSQI). PSQI assesses self-reported sleep quality and sleep disturbance in the preceding month.
At baseline, 3 months, 6 months
Changes in Depression
Time Frame: At baseline, 3 months, 6 months
The depression levels of participants will be assessed using the Beck Depression Inventory-Second Edition (BDI-II). There are 21 items on the BDI-II that measure subjective depression symptoms over the preceding 2 weeks
At baseline, 3 months, 6 months
Changes in Quality of Life
Time Frame: At baseline, 3 months, 6 months
Quality of life of the participants will be measured using the Diabetes Quality of Life-Brief Clinical Inventory (The DQoL-BCI). DQoL-BCI contains 15 questions. Using a Likert scale of 5 points, participants can assess their satisfaction with each DQoL-BCI item (1=Very Dissatisfied/All the Time, 2=Moderately Dissatisfied/Sometimes, 3=Neither/Sometimes, and 4=Moderately Satisfied/Very Seldom).
At baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2022

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

November 11, 2022

First Submitted That Met QC Criteria

November 28, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.1738/UN25.8/KEPK/DL/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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