Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VTT Technical Research Centre of Finland
ClinicalTrials.gov Identifier:
NCT01547156
First received: March 2, 2012
Last updated: March 9, 2016
Last verified: March 2016
  Purpose
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 Intervention
Diabetes Mellitus Type 2
Hypertension
Device: Intervention group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mobile Sipoo a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by VTT Technical Research Centre of Finland:

Primary Outcome Measures:
  • Change in blood pressure [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Change in Hba1c(for diabetes patients) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achieving the desired target range [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Target range for blood pressure is <= 135/85 mmHg. Target range for glycohemoglobin is <= 6.5%.

  • Adverse effects [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    hypotension, RR < 120/80 mmHg

  • Hypoglycemia [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    p-glucose < 3.5 mmol/l

  • Change in body weight [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Change in BMI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Change in medication [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Change in FÍNSIK scores [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547156

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

Responsible Party: VTT Technical Research Centre of Finland
ClinicalTrials.gov Identifier: NCT01547156     History of Changes
Other Study ID Numbers: MobileSipoo 
Study First Received: March 2, 2012
Last Updated: March 9, 2016
Health Authority: Finland: Ethics Committee

Keywords provided by VTT Technical Research Centre of Finland:
patient decision support
telemonitoring
self-management
remote patient monitoring
active assistance technology
selfcare

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

ClinicalTrials.gov processed this record on July 28, 2016