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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: E-mail reports and technical support for mHealth system; Other: Mobile health system

• Registration Number: NCT03078764
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Study Start: 2017-06-09
• Status Verified: 2017-12
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

For patients:

1. poorly controlled type 2 diabetes as indicated by HbA1c ≥ 7.5% recorded within past 6 months
2. aged 20 years and older
3. currently being treated by oral antihyperglycemic
4. communicates and reads in Thai
5. has access to and able to use a touch-tone phone (either a land line or a mobile phone)
6. 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:

1. works in a non-communicable disease clinic.
2. can access email
3. has a mobile telephone.

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Exclusion Criteria

For patients:

1. have participated in other mHealth interventions within 3 months
2. have baseline HbA1c < 7.5%
3. are hospitalized or otherwise at risk for hospitalization
4. are prescribed injected insulin
5. patients and nurses who participated in the usability trial will be ineligible to participate in the pilot trial.

Exclusion criteria:

For nurses: None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community nurses	E-mail reports and technical support for mHealth system	Nurses who receive mHealth report about patients in the patients' arm.
Patient Arm using mHealth	Mobile health system	Patients with uncontrolled type 2 diabetes

Primary Outcome Measures

Name	Time	Method
HbA1c	13 weeks	It refers to glycated haemoglobin, which identifies average plasma glucose concentration.
Diabetes related distress	13 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose	13 weeks	It refers to blood glucose levels after refraining eating or drinking for at least 8 hours.

Trial Locations

Locations (6)

Nongsamwang 1 Health Promoting Hospital; 🇹🇭 Nong Sua, Pathumthani, Thailand

Buengkasam 2 Health Promoting Hospital; 🇹🇭 Nong Sua, Pathumthani, Thailand

Buengbon Health Promoting Hospital; 🇹🇭 Nong Sua, Pathumthani, Thailand

Buengkasam 1 Health Promoting Hospital; 🇹🇭 Nong Sua, Pathumthani, Thailand

Buengshamaor 1 Health Promoting Hospital; 🇹🇭 Nong Sua, Pathumthani, Thailand

Salakru Health Promoting Hospital; 🇹🇭 Nong Sua, Pathumthani, Thailand