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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
NCT03078764 |
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Date of registration:
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07/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand
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Scientific title:
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The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand |
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Date of first enrolment:
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June 9, 2017 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03078764 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Panan Pichayapinyo, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion 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.
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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Other: Mobile health system
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Other: E-mail reports and technical support for mHealth system
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Primary Outcome(s)
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HbA1c
[Time Frame: 13 weeks]
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Diabetes related distress
[Time Frame: 13 weeks]
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Secondary Outcome(s)
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Fasting blood glucose
[Time Frame: 13 weeks]
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Secondary ID(s)
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HUM00118973
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5D43TW009883-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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