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Trial registered on ANZCTR


Registration number
ACTRN12614000956606
Ethics application status
Not yet submitted
Date submitted
17/07/2014
Date registered
8/09/2014
Date last updated
8/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
MiDoctor: A Randomized Trial in Patients with Diabetes
Scientific title
Randomized Trial in Patients with Diabetes in Curacavi, Chile: Can MiDoctor Improve Glycemic Control in Comparison to Usual Care?
Secondary ID [1] 285005 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 292514 0
Hypertension 292515 0
Condition category
Condition code
Metabolic and Endocrine 292819 292819 0 0
Diabetes
Cardiovascular 292820 292820 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the intervention group will be invited to participate for 12 months in "MiDoctor," an automated system that monitors individuals with chronic diseases and promotes self-care by providing timely diagnosis, automated calls, and continual reminders via text messaging. The system reinforces patient attendance, helps patients adhere to medication and lifestyle changes, and alerts health personnel to inadequate adherence or changes in risk factors. Specifically, MiDoctor is a web-based system with an interactive voice response (IVR) component and SMS components. The system makes automated phone calls and sends SMS to the patient and, depending on the patient's response, it will send an email alert and place the patient on a work list for the clinical team to respond. The system calls the patient approximately once a week and sends them 1 SMS per week. Each automated phone call lasts approximately 1.5 minutes.
Intervention code [1] 289838 0
Behaviour
Intervention code [2] 289839 0
Lifestyle
Intervention code [3] 289840 0
Treatment: Devices
Comparator / control treatment
Patients in the control group will not be invited to participate in MiDoctor during the evaluation phase of the study, but will be eligible to enroll in MiDoctor at the end of the evaluation phase. Patients in the control group will receive their usual care for diabetes.
Control group
Active

Outcomes
Primary outcome [1] 292678 0
Hemoglobin A1c, as measured by blood tests ordered by each patient's regular clinician
Timepoint [1] 292678 0
One Year
Primary outcome [2] 292679 0
Adherence with appointments as ascertained from electronic appointment system maintained by Hospital de Curacavi
Timepoint [2] 292679 0
One Year
Secondary outcome [1] 309493 0
Blood Pressure (Systolic and Diastolic), as measured by clinicians at every patient contact with the hospital's ambulatory health centers
Timepoint [1] 309493 0
One Year
Secondary outcome [2] 309494 0
LDL Cholesterol, as measured by blood tests ordered by each patient's regular clinician
Timepoint [2] 309494 0
One Year
Secondary outcome [3] 309495 0
Urine Microalbumin, as measured by blood tests ordered by each patient's regular clinician
Timepoint [3] 309495 0
One Year

Eligibility
Key inclusion criteria
Patients with an established diagnosis of diabetes mellitus type 2, with or without hypertension, registered at Curacavi Hospital, Chile, as of June 15, 2014.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A total of 1,054 eligible patients was identified. Among this group, 650 were randomly assigned to the intervention group, while the remaining 404 were assigned to the control group. Allocation concealment through central randomization via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each of the 1,054 eligible patients was assigned a random number via a computerized random number generating routine. The patients were then ordered according their random number, and the lowest 650 values were assigned to the intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
When an individual in the intervention group is invited to participate, any other eligible individual residing in the same household will also be invited, even if that individual was originally designated as a control.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Since the intervention constitutes an invitation to participate in the MiDoctor program, the study results will be subject to intention-to-treat (ITT) analysis. In addition, a supplementary per-protocol (PP) analysis will be performed based upon acceptance of the invitation to participate. The sample sizes were designed to detect a difference of 0.3 units of hemoglobin A1c at a significance level of 5% and a power of 80%, based on a standard deviation of A1c equal to 1.5.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/10/2014
Actual
Date of last participant enrolment
Anticipated
10/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1054
Accrual to date
Final
Recruitment outside Australia
Country [1] 6221 0
Chile
State/province [1] 6221 0
Curacavi, Region Metropolitana

Funding & Sponsors
Funding source category [1] 289617 0
Hospital
Name [1] 289617 0
Hospital de Curacavi
Country [1] 289617 0
Chile
Primary sponsor type
Individual
Name
Jeffrey E. Harris
Address
Department of Economics
Massachusetts Institute of Technology
77 Massachusetts Avenue, E18-258
Cambridge, Massachusetts 02139 USA
Country
Chile
Secondary sponsor category [1] 288304 0
Commercial sector/Industry
Name [1] 288304 0
eHealthSystems
Address [1] 288304 0
Jose Arrieta 89
Providencia, Santiago
Chile 7500000
Country [1] 288304 0
Chile

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291359 0
Comite de Etica Cientifico (CEC)
Ethics committee address [1] 291359 0
Servicio de Salud Metropolitano Occidente.
Avenida Libertador Bernardo O'Higgins 2429,
Santiago, Region Metropolitana
Chile 8320000
Ethics committee country [1] 291359 0
Chile
Date submitted for ethics approval [1] 291359 0
17/07/2014
Approval date [1] 291359 0
Ethics approval number [1] 291359 0

Summary
Brief summary
A randomized controlled study of MiDoctor, an automated system that uses text messaging (SMS) to reinforce patient attendance, helps patients adhere to medication and lifestyle changes, and alerts health personnel to inadequate adherence or changes in risk factors. The study population consists of 1,054 patients with diabetes type 2, at least 18 years old, registered at Hospital de Curacavi, Chile, of whom 650 will be invited to participate in MiDoctor, while 404 controls will receive their usual care. One-year endpoints will include hemoglobin A1c, blood pressure, LDL cholesterol, urinary microalbumin, and patient adherence to appointments and medications. Intention to treat (ITT) analysis is planned, along with a supplementary per-protocol (PP) analysis of based upon acceptance of the invitation to participate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50022 0
Prof Jeffrey E. Harris
Address 50022 0
Department of Economics
Massachusetts Institute of Technology
77 Massachusetts Avenue, E18-258
Cambridge, Massachusetts 02139 USA
Country 50022 0
United States of America
Phone 50022 0
+1 617 253 2677
Fax 50022 0
+1 617 253 6915
Email 50022 0
[email protected]
Contact person for public queries
Name 50023 0
Francisca Donoso
Address 50023 0
eHealthSystems
Avenida Lucas Pacheco 734
Talagante, Region Metropolitana 9670000
Country 50023 0
Chile
Phone 50023 0
+56 9 7411 94 98
Fax 50023 0
Email 50023 0
[email protected]
Contact person for scientific queries
Name 50024 0
Jeffrey E. Harris
Address 50024 0
Department of Economics
Massachusetts Institute of Technology
77 Massachusetts Avenue, E18-258
Cambridge, Massachusetts 02139
Country 50024 0
United States of America
Phone 50024 0
+1 617 253 2677
Fax 50024 0
+1 617 253 6915
Email 50024 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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