Type 2 Diabetes MellitusNCT03078764
The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand
A study testing Mobile health system and E-mail reports and technical support for mHealth system in people with Type 2 Diabetes Mellitus, run by University of Michigan at 6 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Mobile health system and E-mail reports and technical support for mHealth system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesThailand
- Study dates
- 9 Jun 2017to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Thailand6 sites
Buengbon Health Promoting Hospital
Nong Suea, Changwat Pathum Thani, 12170
Buengkasam 1 Health Promoting Hospital
Nong Suea, Changwat Pathum Thani, 12170
Buengkasam 2 Health Promoting Hospital
Nong Suea, Changwat Pathum Thani, 12170
Buengshamaor 1 Health Promoting Hospital
Nong Suea, Changwat Pathum Thani, 12170
Nongsamwang 1 Health Promoting Hospital
Nong Suea, Changwat Pathum Thani, 12170
Salakru Health Promoting Hospital
Nong Suea, Changwat Pathum Thani, 12170
About this study
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.
Read the 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:
- 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
- Type 2 Diabetes Mellitus
- Being tested
- Mobile health system, E-mail reports and technical support for mHealth system
- Keywords
- Mobile health (mHealth)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health systemOther
Also called mHealth, Interactive Voice Response (IVR)
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Arm using mHealth | Experimental | Patients with uncontrolled type 2 diabetes Receives: Other: Mobile health system |
| Community nurses | Experimental | Nurses who receive mHealth report about patients in the patients' arm. Receives: Other: E-mail reports and technical support for mHealth system |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
It refers to glycated haemoglobin, which identifies average plasma glucose concentration.
Measured: 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.
Measured: 13 weeks
Secondary outcomes (1)
Fasting blood glucose
It refers to blood glucose levels after refraining eating or drinking for at least 8 hours.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start9 Jun 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Panan Pichayapinyo, Mahidol University
- Investigators
- Panan Pichayapinyo, PhD., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078764
- Sponsor's protocol ID
- HUM00118973
- Other IDs
- 5D43TW009883-03
- Status last verified
- Dec 2017
- First submitted
- 7 Mar 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand
- ClinicalTrials.gov ID
- NCT03078764
- Acronym / sponsor ID
- HUM00118973
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Mobile health (mHealth)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Mahidol University, Fogarty International Center of the National Institute of Health
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Arm using mHealth | Experimental | Other: Mobile health systemPatients with uncontrolled type 2 diabetes |
| Community nurses | Experimental | Other: E-mail reports and technical support for mHealth systemNurses who receive mHealth report about patients in the patients' arm. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health systemAlso: mHealth, Interactive Voice Response (IVR)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. | Other | Patient Arm using mHealth |
| E-mail reports and technical support for mHealth systemNurses 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. | Other | Community nurses |
Primary outcome
HbA1c
Time frame: 13 weeks
It refers to glycated haemoglobin, which identifies average plasma glucose concentration.
Diabetes related distress
Time frame: 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.
1 secondary outcome
Fasting blood glucose
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panan Pichayapinyo, PhD. principal investigator
University of Michigan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health system and E-mail reports and technical support for mHealth system in people with Type 2 Diabetes Mellitus, run by University of Michigan at 6 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.