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Mobile Sipoo - Self-management Study

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: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

Mobile Sipoo self-management study aims to improve care and outcomes in prevention of diabetes and hypertension by self-monitoring, providing automatic patient decision support (PDSS) feedback coupled with back-office health coaching and targeting resources according to total cardiovascular risk and need of services.


Condition Intervention
Diabetes Mellitus Type 2
Hypertension
 Device: Active Assistance Technology

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study on the Use of Self-management Tools to Improve Chronic Care

Resource links provided by NLM:

U.S. FDA Resources

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 glycohemoglobin (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 quality of life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Change in BMI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Change in medication intensification or initiation [ 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 standard of care
Active Comparator: Active Assistance Technology
The intervention under study consisted of providing patients with technology (mobile telephone, software application, and assessment devices) for monitoring and remote reporting of hypertension and diabetes health-related parameters from home. The intervention also consisted of providing patients with automatically generated, theory-based, health promotion rich information, motivation, and behavioral skills feedback messages, linked to patients' remote reports of their health parameters, and aimed at strengthening their self-care practices and adherence
 Device: Active Assistance Technology

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 for display of self-monitored data and for developing problem solving skills in self-care based upon self-monitoring results and PDSS reminders or alerts to patients. Interactive contacts with health coaches are also supported through the tethered PHR.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
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.
  • Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated
  • 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
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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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: December 19, 2012
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 19, 2013