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

NCT05629117 | Completed

• 1 other identifier: No.1738/UN25.8/KEPK/DL/2022
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes Text Messaging (DB-TEXT), peer support education, type 2 diabetes

Outcome Measures

Primary Outcomes (4)

• Changes in HbA1C level

  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

  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

  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)

  Blood pressure of participants will be measured using sphygmomanometer

  at baseline, 3 months, 6 months

Secondary Outcomes (4)

• Changes in Fatigue

  At baseline, 3 months, 6 months

• Changes in Sleep Quality

  At baseline, 3 months, 6 months

• Changes in Depression

  At baseline, 3 months, 6 months

• Changes in Quality of Life

  At baseline, 3 months, 6 months

Study Arms (3)

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

EXPERIMENTAL

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

Personalized Diabetes Text Messaging (DB-TEXT) Group

ACTIVE COMPARATOR

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)

Control Group

NO INTERVENTION

Health education related to diabetes management will be provided to the control group once a month during three months

Interventions

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

Personalized Diabetes Text Messaging (DB-TEXT) BEHAVIORAL

Personalized Diabetes Text Messaging (DB-TEXT)

Personalized Diabetes Text Messaging (DB-TEXT) Group

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• People who could not read or write Indonesian
• Had medical diagnostic with cognitive impairments
• Psychiatric disorders, or were diagnosed with cancer

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Xinyi District, 100, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 29, 2022
• Study Start: December 26, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)