Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
Study NCT ID:
NCT02076568
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2014-02-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes and Partnership: Evaluation of a Diabetes Education Module
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2014-02-28', 'studyFirstSubmitQcDate': '2014-02-28', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up', 'timeFrame': 'Baseline, 2-week follow-up , 6-month follow-up', 'description': 'The Diabetes Empowerment Scale was specifically adjusted to cover "partnership" issues. Psychometric criteria for these adjusted scale were evaluated in an independent study'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in problem-specific distress on the adapted Problem Areas in Diabetes (PAID) Scale at the 2-week and 6-month follow-up', 'timeFrame': 'baseline, 2-week follow-up, 6-month follow-up', 'description': 'The PAID scale was specifically adapted to cover "partnership". Psychometric quality was assessed in an independent study'}, {'measure': 'Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up', 'timeFrame': 'baseline, 2-week follow-up, 6-month follow-up', 'description': 'HbA1c will be analyzed in a central laboratory.'}, {'measure': 'Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up', 'timeFrame': 'baseline, 2-week follow-up, 6-month follow-up'}, {'measure': 'Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up', 'timeFrame': 'baseline, 2-week follow-up, 6-month follow-up'}, {'measure': 'Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up', 'timeFrame': 'baseline, 2-week follow-up, 6-month follow-up'}, {'measure': 'Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up', 'timeFrame': 'baseline, 2-week follow-up, 6-month follow-up'}, {'measure': 'Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up', 'timeFrame': 'baseline, 2-week follow-up, 6-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'education', 'randomized', 'prospective'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic "diabetes and partnership". Primary outcome variable is diabetes-specific empowerment regarding diabetes and partnership. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.', 'detailedDescription': 'The module consists of one lesson (duration: 90 minutes). The module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by a trained diabetes educator. Patients are randomized either to the immediate participation in the module or to the control group. Control group is a waiting-list control group. Patients in this waiting-list control group get the education after the completion of the 6-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intensive insulin treatment\n* specific interest in "Diabetes and Partnership"\n* wish to participate in group education\n* informed consent\n* fluent in reading and speaking German language\n\nExclusion Criteria:\n\n* diabetes duration \\< 4 week\n* severe organic disease (e.g. terminal renal disease, cancer with poor prognosis)\n* current treatment of a mental disease\n* cognitive impairment\n* dementia\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02076568', 'acronym': 'PRIMO_Partner', 'briefTitle': 'Diabetes and Partnership: Evaluation of a Diabetes Education Module', 'organization': {'class': 'OTHER', 'fullName': 'Forschungsinstitut der Diabetes Akademie Mergentheim'}, 'officialTitle': 'A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Partnership" in a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NH022014_4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education - Diabetes and Partnership', 'description': 'Patients randomized to this arm, will participate immediately in the education module "Diabetes and Partnership"', 'interventionNames': ['Behavioral: Education - Diabetes and Partnership']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting-list control group', 'description': 'Patients in the control group will get the education with the education module after completion of the 6-month follow-up'}], 'interventions': [{'name': 'Education - Diabetes and Partnership', 'type': 'BEHAVIORAL', 'description': 'Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Partnership" was created. The module covers specific and detailed aspects of the topic "partnership" such as dealing with hypoglycemia, late complications, and talking about diabetes in a relationship. With this module, a more comprehensive education of patients with specific interest in these topics is possible.', 'armGroupLabels': ['Education - Diabetes and Partnership']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Research Institute of the Diabetes Academy Mergentheim (FIDAM)', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '21029', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Zentrum für Diabetologie Bergedorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '71634', 'city': 'Ludwigsburg', 'country': 'Germany', 'facility': 'Diabeteszentrum Ludwigsburg', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}, {'zip': '41462', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Diabetologische Schwerpunktpraxis Neuss', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Norbert Hermanns, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Forschungsinstitut der Diabetes Akademie Mergentheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forschungsinstitut der Diabetes Akademie Mergentheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Research Institut Diabetes Academy Mergentheim', 'investigatorFullName': 'Norbert Hermanns', 'investigatorAffiliation': 'Forschungsinstitut der Diabetes Akademie Mergentheim'}}}}