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
  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:


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
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

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

ClinicalTrials.gov processed this record on October 19, 2014