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

Study Overview
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Personalized Diabetes Text Messaging (DB-TEXT) combined with Peer Support Education
* Behavioral: Personalized Diabetes Text Messaging (DB-TEXT)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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<br>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<br>* 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<br>|
| Active Comparator: Personalized Diabetes Text Messaging (DB-TEXT) Group<br>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)<br>* Personalized Diabetes Text Messaging (DB-TEXT)<br>|
| No Intervention: Control Group<br>Health education related to diabetes management will be provided to the control group once a month during three months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Text Messaging (DB-TEXT), peer support education, type 2 diabetes