Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT05991635
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2023-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Gatekeeper Training for Pharmacists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-08-07', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Socio-demographic characteristics', 'timeFrame': 'Baseline', 'description': 'Age, Gender, Years of work experience'}, {'measure': 'Previous experience with suicide (prevention)', 'timeFrame': 'Baseline and post-test (after a week of access to e-learning)', 'description': 'At baseline: motivation to participate (9 options), previous trainings (yes/no, specify if yes) At baseline and post-test: experience with suicidal patients (contact and confidence; 5 point Likert scale), knowing what to do or who to refer to (5-point Likert scale), knowing where to find information (5-point Likert scale), which actions previously taken in case of suicidal patient (list of 12), to who do you refer (5 options)'}, {'measure': 'Follow-up', 'timeFrame': 'Follow-up (three months after baseline)', 'description': 'Questions concerning: application of acquired skills and knowledge; actions undertaken in context of suicide prevention (12 options); experienced barriers to application of acquired skills and knowledge; need of extra support'}], 'primaryOutcomes': [{'measure': 'Changes in attitudes: Attitudes Towards Suicide Scale (ATTS)', 'timeFrame': 'Change from Baseline (before intervention) to post-test (after a week of access to e-learning)', 'description': "The ATTS is a 37-item to be scored on a 5-point Likert scale (1= disagree completely to 5 = agree completely) to measure participants' attitudes towards suicide."}], 'secondaryOutcomes': [{'measure': 'Changes in self-efficacy: Measurement of Perceived Self-efficacy', 'timeFrame': 'Change from Baseline (before intervention) to post-test (after a week of access to e-learning)', 'description': 'The Measurement of Perceived Self-efficacy is a 10-item self-report questionnaire to be scored on a 4-point Likert scale (1= Completely false to 4 = completely true)'}, {'measure': 'Changes in perceptions/myths', 'timeFrame': 'Change from Baseline (before intervention) to post-test (after a week of access to e-learning)', 'description': 'Self-developped questionnaire: 4 statements to be rated as true or false; 2 question about how participant would feel if a patient said they have suicidal thouhgts'}, {'measure': 'Gatekeeper training evaluation', 'timeFrame': 'Post-test (after a week of access to e-learning)', 'description': '8 evaluative statements about the e-learning to be rated on a 5-point Likert scale (Totally disagree, disagree, neutral, agree, totally disagree).\n\nQuestion to rate the e-learning on a scale of 1 (not good at all) to 10 (excellent) Additionally three open questions where participants can give feedback about what they liked/did not like/ general comments.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate to what extent a gatekeeper training (e-learning) for pharmacists and PTA is effective in changing the attitudes, knowledge, and self-efficacy. Moreover, it aims to examine how they evaluate the training and whether they were able to apply the learned skills in practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old\n* Have access to internet\n* Speak Dutch\n* Working as a (public) pharmacist or pharmaceutical technical assistant (FTA)\n\nExclusion Criteria:\n\n* Hospital pharmacists or industrial pharmacists are not included in this study and thus constitute an exclusion criterion.'}, 'identificationModule': {'nctId': 'NCT05991635', 'briefTitle': 'Evaluation of a Gatekeeper Training for Pharmacists', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Evaluation of a Gatekeeper Training for Pharmacists', 'orgStudyIdInfo': {'id': 'ONZ-2022-0598'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants in this group (all participants) are asked to complete a questionnaire and then receive access to the online gatekeeper training (e-learning) during three days, after which they were asked to complete another questionnaire. After three months, a third questionnaire is sent.', 'interventionNames': ['Behavioral: Gatekeeper training (e-learning)']}], 'interventions': [{'name': 'Gatekeeper training (e-learning)', 'type': 'BEHAVIORAL', 'description': 'The gatekeeper training consists of an interactive e-learning (min. 1h, max. 3h) which includes theoretical knowledge, tips, exercises and relevant examples and cases. The main topics included in the e-learning are:\n\n* Background information on suicide in Flanders (rates)\n* Definitions and theoretical background (suicidal process, integrative explanatory model of suicide)\n* Debunking existing myths about suicide\n* The role of the pharmacist in suicide prevention\n* Signal Recognition\n* Talking about suicide and suicidal thoughts (start the conversation)\n* How and to whom to refer as pharmacist or FTA\n* Medication management and medication in the context of suicide\n* Rights and obligations of a pharmacist/PTA in the context of suicide prevention\n* Self-care', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Flemish Centre of Expertise in Suicide Prevention, Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Gwendolyn Portzky, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}