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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline

Completed

Started Jun 2017

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

March 7, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed

3 months until next milestone

Study Start

First participant enrolled

June 9, 2017

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

March 7, 2017

Last Update Submit

December 20, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

Mobile health (mHealth)

Outcome Measures

Primary Outcomes (2)

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 Outcomes (1)

Fasting blood glucose
13 weeks

Other Outcomes (13)

Sleep quality
13 weeks
Dietary consumption
13 weeks
Physical activity
13 weeks
+10 more other outcomes

Study Arms (2)

Patient Arm using mHealth

EXPERIMENTAL

Patients with uncontrolled type 2 diabetes

Other: Mobile health system

Community nurses

EXPERIMENTAL

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

Other: E-mail reports and technical support for mHealth system

Interventions

Mobile health systemOTHER

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.

Also known as: mHealth, Interactive Voice Response (IVR)

Patient Arm using mHealth

E-mail reports and technical support for mHealth systemOTHER

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.

Community nurses

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
For nurses:
works in a non-communicable disease clinic.
can access email
has a mobile telephone.

You may not qualify if:

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.
For nurses: None

Contact the study team to confirm eligibility.