Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01547156
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : March 10, 2016
Information provided by (Responsible Party):
VTT Technical Research Centre of Finland

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Hypertension Device: Intervention group Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Sipoo a Randomized Controlled Trial
Study Start Date : May 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control group
Control group received usual care
Experimental: Telemonitoring group
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

Primary Outcome Measures :
  1. Change in blood pressure [ Time Frame: 9 months ]
  2. Change in Hba1c(for diabetes patients) [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Achieving the desired target range [ Time Frame: 9 months ]
    Target range for blood pressure is <= 135/85 mmHg. Target range for glycohemoglobin is <= 6.5%.

  2. Adverse effects [ Time Frame: 9 months ]
    hypotension, RR < 120/80 mmHg

  3. Hypoglycemia [ Time Frame: 9 months ]
    p-glucose < 3.5 mmol/l

  4. Change in body weight [ Time Frame: 9 months ]
  5. Change in BMI [ Time Frame: 9 months ]
  6. Change in medication [ Time Frame: 9 months ]
  7. Change in FÍNSIK scores [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01547156

Sipoo Health Care Centre
Sipoo, Finland
Sponsors and Collaborators
VTT Technical Research Centre of Finland

Responsible Party: VTT Technical Research Centre of Finland Identifier: NCT01547156     History of Changes
Other Study ID Numbers: MobileSipoo
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016

Keywords provided by VTT Technical Research Centre of Finland:
patient decision support
remote patient monitoring
active assistance technology

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases