Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT01187069
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2010-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-17', 'studyFirstSubmitDate': '2010-06-14', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Last measurement within 12 months before - and 15 months after nurse participation in the course', 'description': 'Collected from registers (historical data - not measured as a part of this study)'}], 'secondaryOutcomes': [{'measure': 'HDL-cholesterol', 'timeFrame': 'Last measurement within 12 months before - and 15 months after nurse participation in the course', 'description': 'Collected from registers (historical data - not measured as a part of this study)'}, {'measure': 'LDL-cholesterol', 'timeFrame': 'Last measurement within 12 months before - and 15 months after nurse participation in the course', 'description': 'Collected from registers (historical data - not measured as a part of this study)'}, {'measure': 'Perceived autonomy support (HCCQ)', 'timeFrame': '15 months from nurse participation in the course', 'description': 'Modified health care climate quastionaire (Self-determination Theory)'}, {'measure': 'Type of motivation (TSRQ)', 'timeFrame': '15 months from nurse participation in the course', 'description': 'The treatment self-regulation quastionaire (Self-determination Theory)'}, {'measure': 'Perceived competence (PCS)', 'timeFrame': '15 months from nurse participation in the course', 'description': 'perceived competence scale (Self-determination Theory)'}, {'measure': 'Total-cholesterol', 'timeFrame': 'Last measurement within 12 months before - and 15 months after nurse participation in the course', 'description': 'Collected from registers (historical data - not measured as a part of this study)'}, {'measure': 'Self-rated health (SF-12)', 'timeFrame': '15 months from nurse participation in the course'}, {'measure': 'Problem Areas In Diabetes scale (PAID)', 'timeFrame': '15 months from nurse participation in the course'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Motivation', 'patients with type 2 diabetes', 'practice nurses', 'general practice', 'Self-determination Theory'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '24798419', 'type': 'DERIVED', 'citation': 'Juul L, Maindal HT, Zoffmann V, Frydenberg M, Sandbaek A. Effectiveness of a training course for general practice nurses in motivation support in type 2 diabetes care: a cluster-randomised trial. PLoS One. 2014 May 5;9(5):e96683. doi: 10.1371/journal.pone.0096683. eCollection 2014.'}, {'pmid': '22111524', 'type': 'DERIVED', 'citation': 'Juul L, Maindal HT, Zoffmann V, Frydenberg M, Sandbaek A. A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice. BMC Fam Pract. 2011 Nov 24;12:130. doi: 10.1186/1471-2296-12-130.'}]}, 'descriptionModule': {'briefSummary': 'A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour changes. In Denmark, the tendency is that nurses in general practice provide a large part of type 2 diabetes care.\n\nObservational studies support Self-determination Theory by finding autonomous motivation and perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes. Hence, research is needed to develop and test interventions that are autonomy supportive.\n\nAim To develop a training course for practice-nurses in autonomy support in patients with type 2 diabetes, and to evaluate the effect on patient outcomes.\n\nMethods The development of the intervention was based on literature research and expert meetings. The intervention is evaluated in a cluster randomised controlled trial with 40 Danish general practices,\n\n* where nurses, before enrolment in the study, provided consultations to patients with type 2 diabetes,\n* and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.\n\nThe patients will be followed 15 months from nurse-participation in the course. Data will be obtained from registers and patient-questionnaires. The hypothesis is that patients with type 2 diabetes regardless of education level, age, and gender will benefit from the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The intervention-study comprises 40 general practices were:\n\n 1. more than 50% of the patients with type 2 diabetes, who had participated in diabetes-consultations during the last year from the invitation-date to the project, were seen by a nurse at least once, stated by the practice. The diabetes-consultation should not only include examinations (blood tests and blood pressure measurement), but should also include communication about living with type 2 diabetes ;\n 2. enrollment in the project before registration deadline (three weeks after invitation).\n\nPatients with diabetes, alive and affiliated the practices by May 2011, were identified in a a validated diabetes database based on health registers; The national Patient Registry, The national Health Insurance Service registry, the prescription database and the laboratory database in the county.'}, 'identificationModule': {'nctId': 'NCT01187069', 'briefTitle': 'A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care. A Pragmatic Cluster Randomised Controlled Trial in Primary Health Care', 'orgStudyIdInfo': {'id': '2009-41-3065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training course for practice nurses in autonomy support', 'interventionNames': ['Behavioral: Training course for practice nurses in autonomy support']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control practices were randomly drawn from among intervention practice applicants and were informed by mail about their status as control practice.'}], 'interventions': [{'name': 'Training course for practice nurses in autonomy support', 'type': 'BEHAVIORAL', 'description': 'An interactive course consisting of 4X4 hours education in autonomy support over a 6 months period. The main-components in the course are 1) communication skills, 2) introduction to patient work-sheets and 3) a quick up-to-date knowledge about treatment recommendations of type 2 diabetes. Furthermore, the nurses in the intervention-practices receive a half an hour support-visit 4-5 months after the end of the course.', 'armGroupLabels': ['Training course for practice nurses in autonomy support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of General Practice, School of Public Health, Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}, {'name': 'Sygekassernes Helsefond', 'class': 'OTHER'}, {'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}