Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology
Mobile Sipoo a Randomized Controlled Trial
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 2, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 10, 2016
March 1, 2016
10 months
March 2, 2012
March 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in blood pressure
9 months
Change in Hba1c(for diabetes patients)
9 months
Secondary Outcomes (7)
Achieving the desired target range
9 months
Adverse effects
9 months
Hypoglycemia
9 months
Change in body weight
9 months
Change in BMI
9 months
- +2 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONControl group received usual care
Telemonitoring group
EXPERIMENTALIntervention 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sipoo Health Care Centre
Sipoo, Finland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2012
First Posted
March 7, 2012
Study Start
May 1, 2011
Primary Completion
March 1, 2012
Study Completion
June 1, 2012
Last Updated
March 10, 2016
Record last verified: 2016-03