Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT02115412
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2014-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Medication Non-adherence Model (UK)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'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': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-25', 'studyFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '18 months', 'description': 'Any adverse events (eg: hospitalisation, elective surgeries), which may have resulted change in their daily medication routine Time Frame: 18 months, meaning 12 month prior to enrollment + 6 months during the study'}], 'primaryOutcomes': [{'measure': 'Adherence determinants', 'timeFrame': '6 months', 'description': 'Self-reported behavioral questionnaire completed at 3 monthly intervals'}], 'secondaryOutcomes': [{'measure': 'Medication usage', 'timeFrame': '18 months', 'description': 'Collecting refill data from the pharmacy where patients are registered to. Time Frame: 18 months (12 month prior to enrollment + 6 months during the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Chronic Obstructive Pulmonary Disease', 'Chronic Illness', 'Primary Care', 'Medication Management at Home']}, 'descriptionModule': {'briefSummary': 'Research has shown that nearly 50% of patients with chronic conditions around the globe do not adhere to their prescribed medicine, leading to enormous cost to the healthcare providers. Non-adherence can be due to various forms and have multiple causes.\n\nTo address this need, Philips Research has developed Medication Non-adherence model. This tool will help in developing a systemic way of assessing medication non-adherence and providing decision support for targeted intervention to healthcare professionals. The aim of this study is to validate this model with 750 chronically ill patients in UK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with chronic illness taking more than 3 medications. These patients will be between the age of 18 - 89', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic disease between 18 -89 years old.\n* Chronic medication use (\\> 3 medications; excluding analgesic, ointment and eye drop medication)\n* Patients registered with a given Pharmacy at least 1 year before entering into the study.\n\nExclusion Criteria:\n\n* Patients who are illiterate in English.\n* Patients who are unable to give consent to the study.\n* Enrolled in another clinical trial, which requires change in their routinely medication.\n* Patients currently using automatic medication reminder services (excluding the pharmacy service).\n* Patients with dementia or any other mental conditions, that might affects the accuracy of the answers provided.'}, 'identificationModule': {'nctId': 'NCT02115412', 'briefTitle': 'Validation of Medication Non-adherence Model (UK)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Healthcare'}, 'officialTitle': 'Validation of Medication Non-adherence Model (UK)', 'orgStudyIdInfo': {'id': 'PhilipsResearch-2007-0116'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'medication non-adherence'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BL3 6TL', 'city': 'Bolton', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Swan Lane Medical Centre', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'zip': 'PE30 4DY', 'city': 'Kings Lynn', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Vida Health, 39 Gayton Road', 'geoPoint': {'lat': 52.75172, 'lon': 0.39516}}, {'zip': 'NR33 8LG', 'city': 'Carlton Colville, Lowestoft', 'state': 'Suffolk', 'country': 'United Kingdom', 'facility': 'Rosedale Surgery'}, {'zip': 'NR18 ORF', 'city': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Wymondham Medical Practice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}