Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

VTT Technical Research Centre of Finland

Status: Completed

Conditions: Hypertension; Diabetes Mellitus Type 2

Treatments: Device: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT01547156

MobileSipoo

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Control group

No Intervention group

Description:

Control group received usual care

Telemonitoring group

Experimental group

Description:

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.

Treatment:

Device: Intervention group