Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-30 @ 7:39 AM
Study NCT ID:
NCT04312295
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2020-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACP Knowledge Scale', 'timeFrame': 'pretest (before training program), Immediate test (after training program), post-test (3 month after training program)', 'description': "To evaluate the change of knowledge score for nurses from start of training program to end of training program 3 month later. Nurses' knowledge of discussing ACP will measure using the ACP knowledge Scale developed for this study. This Scale consisting of 20 items; each item consisted of a statement for which a participant could answer ''Yes'' to give 1 point, ''No'' or ''don't know'' to get 0 point. A higher scores indicates more knowledge. Data will analysis using SPSS 22.0 statistical software. Descriptive statistics are calculating as frequencies with percentages and means with standard deviation. Generalized estimating equation (GEE) methods with exchangeable working covariance structure will use to examine group differences in ACP knowledge outcomes, adjusting for changes over time. The GEE provides unbiased estimates of intervention effects."}, {'measure': 'ACP Confidence Scale', 'timeFrame': 'pretest (before training program), Immediate test (after training program), post-test (3 month after training program)', 'description': "To evaluate the change of confidence score for nurses from start of training program to end of training program 3 month later. Nurses' self-confidence of communication skills in discussing ACP will measure using the ACP Confidence Scale developed for this study. The instrument consists of 12 items with response options from 0 (not confident at all) to 10(very confident), reflecting an individual's level of confident; higher scores indicates greater confidence. Data will analysis using SPSS 22.0 statistical software. Descriptive statistics are calculating as frequencies with percentages and means with standard deviation. Generalized estimating equation (GEE) methods with exchangeable working covariance structure will use to examine group differences in ACP confidence outcomes, adjusting for changes over time. The GEE provides unbiased estimates of intervention effects."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '34428209', 'type': 'DERIVED', 'citation': 'Chen JO, Chang SC, Lin CC. The development and pilot testing of an ACP simulation-based communication-training program: Feasibility and acceptability. PLoS One. 2021 Aug 24;16(8):e0254982. doi: 10.1371/journal.pone.0254982. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This study was to evaluate the effects of ACP simulation-based communication training program (ACP-SCT program) for nurses to discuss ACP with chronic kidney disease patients', 'detailedDescription': 'The ACP-SCT program was including three stages, as follows Stage I: To discuss ACP knowledge and law Objective: Opportunity to share experiences, and develop a mutual understanding of the the challenge of ACPdiscussing with CKD patients.\n\nStage II: communication skills section and Feedback section Objective: 1. To provide a structured approach to managing ACP discussions. 2. Opportunity to practice communication skills in a safe environment 3. Opportunity to discuss their experiences of the training program, and reflect future on their own practice and experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants were nephrology nurses and worked at least one year\n\nExclusion Criteria:\n\n* Non-nephrology nurses'}, 'identificationModule': {'nctId': 'NCT04312295', 'briefTitle': 'ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Effects of an ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients: A Longitudinal Study', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(I)-20150279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACP-SCT program', 'description': 'The ACP simulation-based communication training (ACP-SCT)program was designed 12 hours (4hours/week) workshop for nephrology nurses.', 'interventionNames': ['Behavioral: ACP-SCT program']}, {'type': 'NO_INTERVENTION', 'label': 'Without ACP-SCT program', 'description': 'The control group only gives the ACP simulation-based communication training program handbook.'}], 'interventions': [{'name': 'ACP-SCT program', 'type': 'BEHAVIORAL', 'description': "The ACP-SCT program was designed to improve nurses' knowledge and competence in discussing ACP with Chronic Kidney Disease patients.", 'armGroupLabels': ['ACP-SCT program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90741', 'city': 'Pingtung City', 'state': 'Yanpu Township', 'country': 'Taiwan', 'facility': 'Tajen University', 'geoPoint': {'lat': 22.67135, 'lon': 120.48814}}], 'overallOfficials': [{'name': 'Jui-O Chen, Mater', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tajen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}