Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

Hypertension Clinical Trial

Official title:

Mobile Sipoo a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547156
• Other study ID #: MobileSipoo
• Status: Completed
• Phase: N/A
• First received: March 2, 2012
• Last updated: March 9, 2016
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2016
• Source: VTT Technical Research Centre of Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Device:
• Intervention group

Locations

Country	Name	City	State
Finland	Sipoo Health Care Centre	Sipoo

Sponsors (1)

Lead Sponsor	Collaborator
VTT Technical Research Centre of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure		9 months	No
Primary	Change in Hba1c(for diabetes patients)		9 months	No
Secondary	Achieving the desired target range	Target range for blood pressure is <= 135/85 mmHg. Target range for glycohemoglobin is <= 6.5%.	9 months	No
Secondary	Adverse effects	hypotension, RR < 120/80 mmHg	9 months	No
Secondary	Hypoglycemia	p-glucose < 3.5 mmol/l	9 months	No
Secondary	Change in body weight		9 months	No
Secondary	Change in BMI		9 months	No
Secondary	Change in medication		9 months	No
Secondary	Change in FÍNSIK scores		9 months	No