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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-09

Study Completion Date

2017-12-01

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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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Mobile health (mHealth)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patient Arm using mHealth

Patients with uncontrolled type 2 diabetes

Group Type EXPERIMENTAL

Mobile health system

Intervention Type OTHER

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.

Community nurses

Nurses who receive mHealth report about patients in the patients' arm.

Group Type EXPERIMENTAL

E-mail reports and technical support for mHealth system

Intervention Type OTHER

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.

Interventions

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Mobile health system

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.

Intervention Type OTHER

E-mail reports and technical support for mHealth system

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.

Intervention Type OTHER

Other Intervention Names

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mHealth Interactive Voice Response (IVR)

Eligibility Criteria

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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.

For nurses:

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

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.

For nurses: None

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Panan Pichayapinyo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Panan Pichayapinyo, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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