Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

Study Overview
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Brief Summary
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Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. The feedback system is coupled with back-office health coaching.

Detailed Description
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Self-monitored data from blood pressure meters (SMBP), glucometers (SMBG), scales and pedometers are transferred by mobile phone terminals to a tethered personal health record (PHR) integrated with the provider EHR. The PHR application includes tools to display of self-monitoring data.

Official Title
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Mobile Sipoo a Randomized Controlled Trial

Conditions
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Hypertension, Diabetes Mellitus Type 2

Intervention / Treatment
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* Device: Intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study. For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11% use of diabetes medication Exclusion Criteria: Patients who decline to participate Patients specifically excluded by the health centre physician Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring Pregnancy Patients with a life expectance of less than one year Patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months. Patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group received usual care | |
| Experimental: Telemonitoring group<br>Intervention patients were given a remote patient monitoring toolbox that included a mobile telephone, software application, and assessment devices for measuring and remote reporting of hypertension and diabetes -related health parameters at home. The monitored parameters were body weight, steps, blood pressure and blood glucose. Based on their self-monitored data, patients received feedback that was automatically generated, theory-based, health promotion rich information that aimed at strengthening their self-care practices. | Device: Intervention group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure |  | 9 months | 
| Change in Hba1c(for diabetes patients) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving the desired target range | Target range for blood pressure is <= 135/85 mmHg. Target range for glycohemoglobin is <= 6.5%. | 9 months | 
| Adverse effects | hypotension, RR < 120/80 mmHg | 9 months | 
| Hypoglycemia | p-glucose < 3.5 mmol/l | 9 months | 
| Change in body weight |  | 9 months | 
| Change in BMI |  | 9 months | 
| Change in medication |  | 9 months | 
| Change in FÍNSIK scores |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient decision support, telemonitoring, self-management, remote patient monitoring, active assistance technology, selfcare