Clinical trial NCT05629117: Personalized Diabetes Text Messaging (DB-TEXT) Combined With Peer Support Education in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes Text Messaging (DB-TEXT), peer support education, type 2 diabetes
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 83
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in HbA1C level
timeFrame: at baseline, 3 months, 6 months
measure: Changes in fasting blood glucose level
timeFrame: at baseline, 3 months, 6 months
measure: Changes in Lipids level including total cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) , and triglycerides
timeFrame: at baseline, 3 months, 6 months
measure: Changes in Blood Pressure Level including Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
timeFrame: at baseline, 3 months, 6 months
Secondary outcomes:
measure: Changes in Fatigue
timeFrame: At baseline, 3 months, 6 months
measure: Changes in Sleep Quality
timeFrame: At baseline, 3 months, 6 months
measure: Changes in Depression
timeFrame: At baseline, 3 months, 6 months
measure: Changes in Quality of Life
timeFrame: At baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Medical University
state: Xinyi District
Study officials:
References: