The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand

Study Overview
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Brief Summary
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This project explores the feasibility of using automated telephone calls to adult patients with type 2 diabetes to improve diabetes self-management in Thailand. This line of work could significantly extend Thai nurses' ability to manage this growing epidemic, and ultimately reduce the suffering and costs caused by diabetes in Thailand.

Detailed Description
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There is a serious shortage of community nurses to address Thailand's significant and expanding burden of poorly controlled type 2 diabetes. However, mobile health (mHealth) strategies are likely to significantly improve and extend Thai nurses' ability to monitor and manage these patients. This study aims to: 1) investigate the feasibility and acceptability of a culturally- and clinically-adapted mHealth intervention with adult Thai diabetic patients and their community nurses, and 2) estimate the intervention's effect upon glycated hemoglobin (HbA1c), fasting blood glucose, self-management behaviors, and diabetes-related distress in uncontrolled type 2 diabetes. Thirty-six patients with poorly controlled type 2 diabetes (along with their regular nurses) will be recruited through an established community clinic network. After baseline clinical and behavioral assessment, patients will receive 12 weeks of automated 10-minute weekly Interactive Voice Response (IVR) calls to provide monitoring and self-management support related to glycemic symptoms, medication adherence, and several self-care behaviors. Patients' clinical nurse will receive weekly summaries of each IVR call by text message and email with guidance on Thai-appropriate best practices. Principal investigator will receive email whenever patients report a potentially urgent issue by IVR, i.e., symptoms of hypoglycemia, or inadequate supply of medication. Immediately after the 12-week intervention concludes, clinical and behavioral variables will be reassessed and a mixed-methods process evaluation will be performed.

Official Title
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The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Mobile health system
* Other: E-mail reports and technical support for mHealth system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For patients: poorly controlled type 2 diabetes as indicated by HbA1c ≥ 7.5% recorded within past 6 months aged 20 years and older currently being treated by oral antihyperglycemic communicates and reads in Thai has access to and able to use a touch-tone phone (either a land line or a mobile phone) free of major physical, cognitive, or psychiatric impairment (per medical records and PI discretion) that would prevent them from participating meaningfully in the intervention. Inclusion criteria: For nurses: works in a non-communicable disease clinic. can access email has a mobile telephone. Exclusion Criteria: For patients: have participated in other mHealth interventions within 3 months have baseline HbA1c < 7.5% are hospitalized or otherwise at risk for hospitalization are prescribed injected insulin patients and nurses who participated in the usability trial will be ineligible to participate in the pilot trial. Exclusion criteria: For nurses: None

Ages Eligible for Study
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Minimum Age: 20 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Arm using mHealth<br>Patients with uncontrolled type 2 diabetes | Other: Mobile health system<br>* Patients will receive weekly automated IVR telephone calls for 12 weeks to assess their glycemic symptoms, medication adherence, dietary consumption, physical activity, sleep, and foot care. These 5-10 minute calls will follow a standardized Thai language IVR script developed specifically for this study.<br>* Other names: Interactive Voice Response (IVR);|
| Experimental: Community nurses<br>Nurses who receive mHealth report about patients in the patients' arm. | Other: E-mail reports and technical support for mHealth system<br>* Nurses will also receive a technical troubleshooting guide, and have similar access to live telephone technical support. Once their patients' calls begin, nurses will begin receiving weekly e-mail reports summarizing each patients' assessment results, any active self-management problems the patients reported, and suggested strategies for supporting the patient's self-management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | It refers to glycated haemoglobin, which identifies average plasma glucose concentration. | 13 weeks | 
| Diabetes related distress | It will be measured using the emotional and regimen subscales of a Thai translation of the well-validated Diabetes Distress Scale. This is a reliable and validated scale, and correlates with other measures of emotional distress. The responses range from 1-6. The higher scores indicate a greater degree of distress. | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose | It refers to blood glucose levels after refraining eating or drinking for at least 8 hours. | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile health (mHealth)