Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01547156
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2012-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-09', 'studyFirstSubmitDate': '2012-03-02', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': '9 months'}, {'measure': 'Change in Hba1c(for diabetes patients)', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Achieving the desired target range', 'timeFrame': '9 months', 'description': 'Target range for blood pressure is \\<= 135/85 mmHg. Target range for glycohemoglobin is \\<= 6.5%.'}, {'measure': 'Adverse effects', 'timeFrame': '9 months', 'description': 'hypotension, RR \\< 120/80 mmHg'}, {'measure': 'Hypoglycemia', 'timeFrame': '9 months', 'description': 'p-glucose \\< 3.5 mmol/l'}, {'measure': 'Change in body weight', 'timeFrame': '9 months'}, {'measure': 'Change in BMI', 'timeFrame': '9 months'}, {'measure': 'Change in medication', 'timeFrame': '9 months'}, {'measure': 'Change in FÍNSIK scores', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['patient decision support', 'telemonitoring', 'self-management', 'remote patient monitoring', 'active assistance technology', 'selfcare'], 'conditions': ['Diabetes Mellitus Type 2', 'Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vtt.fi/sites/care4me/index.jsp?lang=en', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study.\n* For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated\n* Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11%\n* use of diabetes medication\n\nExclusion Criteria:\n\n* Patients who decline to participate\n* Patients specifically excluded by the health centre physician\n* Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring\n* Pregnancy\n* Patients with a life expectance of less than one year\n* Patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months.\n* Patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study'}, 'identificationModule': {'nctId': 'NCT01547156', 'briefTitle': 'Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology', 'organization': {'class': 'OTHER', 'fullName': 'VTT Technical Research Centre of Finland'}, 'officialTitle': 'Mobile Sipoo a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MobileSipoo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group received usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Telemonitoring group', 'description': '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.', 'interventionNames': ['Device: Intervention group']}], 'interventions': [{'name': 'Intervention group', 'type': 'DEVICE', 'armGroupLabels': ['Telemonitoring group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sipoo', 'country': 'Finland', 'facility': 'Sipoo Health Care Centre', 'geoPoint': {'lat': 60.37752, 'lon': 25.26906}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VTT Technical Research Centre of Finland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}