Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-27 @ 4:26 PM
Study NCT ID:
NCT03979768
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2019-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Assessment of Type 2 Diabetes in Pharmacies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eight community pharmacies offered a diabetes risk assessment including a diabetes risk assessment test only, while 11 community pharmacies'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-15', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with undiagnosed type 2 diabetes', 'timeFrame': '2 months', 'description': 'Number of Participants with undiagnosed type 2 diabetes'}], 'secondaryOutcomes': [{'measure': 'Explore if there was any difference in the number of participants with a high risk of developing type 2 diabetes in the risk test only (RTO)- group and the group that also offered a HbA1c-measurement (HbA1c-group)', 'timeFrame': 'Baseline', 'description': 'Find the number of participants with a high risk of developing type 2 diabetes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Background: Due to lack of clear symptoms, type 2 diabetes can remain undetected for many years. Our aim was to explore the capacity of Norwegian community pharmacies to identify people at high risk of developing type 2 diabetes and the impact of the risk assessment service on self-rated health.\n\nMethods: Nineteen community pharmacies were randomly allocated to a diabetes risk test only- group or Haemoglobin A1c (HbA1c) -group were the participants with a high risk of developing type 2 diabetes also received a HbA1c-measurement. Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. The pharmacists at the 11 HbA1c pharmacies were also trained in how to perform the HbA1c- measurement. During six months, pharmacy customers equal or over 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. In the risk test only-group, participants with a high risk of developing type 2 diabetes were referred to their general practitioner for follow-up, while in the HbA1c-group, participants with HbA1c ≥ 48 mmol/ mol (6.5%) were referred to their general practitioner.', 'detailedDescription': 'Background: Due to lack of clear symptoms, type 2 diabetes can remain undetected for many years. Our aim was to explore the capacity of Norwegian community pharmacies to identify people at high risk of developing type 2 diabetes and the impact of the risk assessment service on self-rated health.\n\nMethods: Nineteen community pharmacies were randomly allocated to a diabetes risk test only- group or Haemoglobin A1c (HbA1c) -group were the participants with a high risk of developing type 2 diabetes also received a HbA1c-measurement. Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. The pharmacists at the 11 HbA1c pharmacies were also trained in how to perform the HbA1c- measurement. During six months, pharmacy customers equal or above 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. In the risk test only-group, participants with a high risk of developing type 2 diabetes were referred to their general practitioner for follow-up, while in the HbA1c-group, participants with HbA1c ≥ 48 mmol/ mol (6.5%) were referred to their general practitioner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- age equal to or above 45 years old (increased from 18 years in the feasibility study), and being able to read and write Norwegian/English.\n\nExclusion Criteria:\n\n\\- known diabetes, pregnancy and blood diseases that may affect measurement of Haemoglobin A1c (HbA1c).'}, 'identificationModule': {'nctId': 'NCT03979768', 'briefTitle': 'Risk Assessment of Type 2 Diabetes in Pharmacies', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Risk Assessment and HaemoglobinA1c (HbA1c) -Measurement in Community Pharmacies to Identify People With Undiagnosed Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2016/808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risk Assessment Only pharmacies (RTO-group)', 'description': 'Offered a diabetes risk assessment service without any blood sample testing.', 'interventionNames': ['Other: Diabetes risk assessment service in Norwegian community pharmacies']}, {'type': 'EXPERIMENTAL', 'label': 'HbA1c-group /pharmacies', 'description': 'Offered a diabetes risk assessment service including a measurement of Haemoglobin A1c (HbA1c) to the people with a high risk of developing type 2 diabetes on the risk assessment form (The Finnish Diabetes Risc Score (FINDRISC) to those with a western background, and Leicester Risk Assessment (LRA) form for those with a non-western background.', 'interventionNames': ['Other: Diabetes risk assessment service in Norwegian community pharmacies']}], 'interventions': [{'name': 'Diabetes risk assessment service in Norwegian community pharmacies', 'type': 'OTHER', 'description': 'Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. During six months, pharmacy customers equal or above 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health.', 'armGroupLabels': ['HbA1c-group /pharmacies', 'Risk Assessment Only pharmacies (RTO-group)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Aslaug Johanne Risøy, PhDCandidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}