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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05629117
• Other study ID #: No.1738/UN25.8/KEPK/DL/2022
• Status: Completed
• Phase: N/A
• Start date: December 26, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: August 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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
• Personalized Diabetes Text Messaging (DB-TEXT)
Personalized Diabetes Text Messaging (DB-TEXT)

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei City	Xinyi District

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1C level	HbA1C level of participants will be assessed in the laboratory test in hospital	at baseline, 3 months, 6 months
Primary	Changes in fasting blood glucose level	Fasting blood glucose level of participants will be assessed using glucometer	at baseline, 3 months, 6 months
Primary	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
Primary	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	Changes in Fatigue	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
Secondary	Changes in Sleep Quality	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
Secondary	Changes in Depression	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
Secondary	Changes in Quality of Life	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