Clinical trial NCT03078764: The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand
Official title: The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Mobile health (mHealth)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Mahidol University
name: Fogarty International Center of the National Institute of Health
First posted: 2017-03-13
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: HbA1c
timeFrame: 13 weeks
measure: Diabetes related distress
timeFrame: 13 weeks
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: 13 weeks
Other outcomes:
measure: Sleep quality
timeFrame: 13 weeks
measure: Dietary consumption
timeFrame: 13 weeks
measure: Physical activity
timeFrame: 13 weeks
measure: Foot care
timeFrame: 13 weeks
measure: Symptoms of hypoglycemia
timeFrame: 13 weeks
measure: Depressive symptoms severity
timeFrame: 13 weeks
measure: Readiness for change
timeFrame: 13 weeks
measure: Diabetes self-efficacy
timeFrame: 13 weeks
measure: Medical adherence
timeFrame: 13 weeks
measure: Social support
timeFrame: 13 weeks
measure: Health literacy
timeFrame: 13 weeks
measure: Client satisfaction
timeFrame: 13 weeks
measure: Self-efficacy (for nurse)
timeFrame: 13 weeks
Locations:
city: Nong Sua
country: Thailand
facility: Buengbon Health Promoting Hospital
state: Pathumthani
city: Nong Sua
country: Thailand
facility: Buengkasam 1 Health Promoting Hospital
state: Pathumthani
city: Nong Sua
country: Thailand
facility: Buengkasam 2 Health Promoting Hospital
state: Pathumthani
city: Nong Sua
country: Thailand
facility: Buengshamaor 1 Health Promoting Hospital
state: Pathumthani
city: Nong Sua
country: Thailand
facility: Nongsamwang 1 Health Promoting Hospital
state: Pathumthani
city: Nong Sua
country: Thailand
facility: Salakru Health Promoting Hospital
state: Pathumthani
Study officials:
affiliation: University of Michigan
name: Panan Pichayapinyo, PhD.
role: PRINCIPAL_INVESTIGATOR
References: