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OpenTrials
Completed

NCT Number: NCT01547156

Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sipoo Health Care Centre

Sipoo, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Device

Primary outcomes

  1. Change in blood pressure

    Time frame: 9 months

  2. Change in Hba1c(for diabetes patients)

    Time frame: 9 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

VTT Technical Research Centre of Finland

Other

Registry information

Official study title

Mobile Sipoo a Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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