Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 8:37 PM
Study NCT ID:
NCT01317459
Status:
UNKNOWN
Last Update Posted:
2015-09-10
First Post:
2011-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Self-determination - Promoting Self-management in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000079102', 'term': 'Empowerment'}], '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': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-09', 'studyFirstSubmitDate': '2011-03-11', 'studyFirstSubmitQcDate': '2011-03-16', 'lastUpdatePostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': '0, 9 and 18 months'}], 'secondaryOutcomes': [{'measure': 'Who 5', 'timeFrame': '0, 9 and 18 months'}, {'measure': 'TSRQ scales', 'timeFrame': '0, 9 and 18 months'}, {'measure': 'PAID scales', 'timeFrame': '0, 9 and 18 months'}, {'measure': "Rosenberg's self-esteem scale", 'timeFrame': '0, 9 and 18 months'}, {'measure': 'PCD scales', 'timeFrame': '0, 9 and 18 months'}, {'measure': 'HCCQ scales', 'timeFrame': '0, 9 and 18 months'}, {'measure': 'DDS scales', 'timeFrame': '0, 9 and 18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Self management', 'Diabetes type one', 'Empowerment', 'Intrinsic motivation'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '30096144', 'type': 'DERIVED', 'citation': 'Mohn J, Igland J, Zoffmann V, Peyrot M, Graue M. Factors explaining variation in self-esteem among persons with type 1 diabetes and elevated HbA1c. PLoS One. 2018 Aug 10;13(8):e0201006. doi: 10.1371/journal.pone.0201006. eCollection 2018.'}, {'pmid': '28674125', 'type': 'DERIVED', 'citation': 'Mohn J, Graue M, Assmus J, Zoffmann V, Thordarson H, Peyrot M, Rokne B. The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c >/=64 mmol/mol: a group-based randomised controlled trial. BMJ Open. 2017 Jul 3;7(6):e013295. doi: 10.1136/bmjopen-2016-013295.'}]}, 'descriptionModule': {'briefSummary': "Background: 50% of people with diabetes are living with too high blood sugars and increased risk of diabetes related complications together with poor quality of life. The need to improve diabetes care by better enabling patients to utilise their individual and local resources to self-manage the condition is widely recognized, yet there is a lack of access to evidence-based patient-centred healthcare interventions. At present the individual patient's judgement of own concrete situation mostly remains unexplored and insufficiently used in decision-making causing that problems perceived by the patient in living with the illness remain unrecognised and insufficiently resolved.\n\nAim and Methods: Guided self-determination (GSD) is an educational method developed to promote patient autonomy, participation, skills building and intrinsic motivation. In this evidence-based group-intervention the main objective is to implement and evaluate GSD through a randomised controlled trial. GSD methods will be performed seven times for the intervention group. The control group will receive traditional out-patient consultations - 'care as usual' Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective in preventing late complications and enhanced psychosocial health. GSD is presumably an intervention providing psychosocial support applicable in busy clinical practice.\n\nAn alliance is established between Haukeland University Hospital, Norway and Steno Diabetes centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College, and Bergen University to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiabetes type one, HbA1c \\>= 8%\n\nExclusion Criteria:\n\nPregnancy, decreased cognitive function and/or serious mental health disturbances, language barriers to the Norwegian language'}, 'identificationModule': {'nctId': 'NCT01317459', 'acronym': 'GSD', 'briefTitle': 'Guided Self-determination - Promoting Self-management in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.', 'orgStudyIdInfo': {'id': '2010/1325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counselling', 'interventionNames': ['Behavioral: Guided self-determination']}, {'type': 'EXPERIMENTAL', 'label': 'No intervention', 'description': 'Care as usual', 'interventionNames': ['Behavioral: Guided self-determination']}], 'interventions': [{'name': 'Guided self-determination', 'type': 'BEHAVIORAL', 'description': 'Group counselling', 'armGroupLabels': ['Lifestyle counselling', 'No intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Helse Vest HF, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Marit Graue, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bergen University College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}