Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-01 @ 11:17 PM
Study NCT ID:
NCT01898702
Status:
UNKNOWN
Last Update Posted:
2013-07-23
First Post:
2013-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on Diabetes Expert Patients Programme
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-21', 'studyFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2013-07-11', 'lastUpdatePostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated hemoglobin A', 'timeFrame': 'At baseline, and at 8th and 14th months of follow-up', 'description': 'Change in glycosylated hemoglobin A percentage level'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'At baseline, and at 8th and 14th months of follow-up', 'description': 'Change in scores from Diabetes quality of life questionnaire'}, {'measure': 'Health services utilization', 'timeFrame': '12 months before inclusion and 12 months after intervention ends', 'description': 'Number of general practitioner consultations, number of outpatient visits, number of emergency department visits, number of hospital admissions and length of stay. All of them diabetes related.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether participation in a diabetes expert patients programme course is effective in self-management of a chronic condition such as diabetes, if it reduces Haemoglobin A glycosylated levels, improves patient's quality of life, and prevents the use of some health services.", 'detailedDescription': 'The intervention consists in taking part in a diabetes expert patients programme course led by a teaching patient who has experience on chronic disease since he also suffers diabetes. The course is intended for 10 to 15 patients and it is scheduled on 9-weekly sessions (about two hours each session). A nurse supervises the group and observes it without taking part neither on dialogs nor presentations; this nurse helps teaching patient only on logistic needs.\n\nFirst session main contents are on group operation rules (informed consent expression, confidentiality rules, ...), on reasons and expected results of this kind of self-care support programmes and on general aims and purposes. After explanations, patients are invited to answer a set of validated questionnaires on social, demographic and clinical data (including treatments and comorbidities), diabetes knowledge, self-care and self-assessment and quality of life. In this session body weight, arterial pressure and waist perimeter are also measured and registered. The most recent value (until three months before inclusion) of Haemoglobin A glycosylated will be collected from the lab information system.\n\nThe following sessions (from second to ninth) will approach several disease aspects like: what diabetes is, its diagnostic and treatment, acute and chronic complications, food and eating habits, physical exercise and healthy lifestyles, treatment (drugs and insulin) and disease self-control and self-care.\n\nWhen intervention finishes, a follow-up period starts. At eighth and at 14th month from inclusion, participants will be summoned to provide again answers to questionnaires on knowledge, self-care, and quality of life. At both times, levels of Haemoglobin A glycosylated are also measured.\n\nPatients assigned at control branch are summoned at inclusion to obtain complete baseline data, and also at month 8th and at month 14th. On these three occasions, these subjects answer the same questionnaires (including clinical, morbidity data and lab information) administered to intervention group patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus, Type 2\n* Older than 18\n\nExclusion Criteria:\n\n* Dementia\n* Psychosis\n* Home nursing\n* Mental disabled people\n* Subjects unable to express themselves in Spanish or catalan languages\n* Health professionals\n* Subjects included simultaneously in other lifestyle counseling or health education programmes'}, 'identificationModule': {'nctId': 'NCT01898702', 'acronym': 'EPPD-ICS', 'briefTitle': 'Clinical Trial on Diabetes Expert Patients Programme', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Expert Patients Programme Effectiveness on Diabetes Control. A Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'EPPD-2012-ICS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes expert patients programme', 'description': 'Diabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course', 'interventionNames': ['Behavioral: Diabetes expert patients programme']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No intervention', 'description': "Don't participate in a scheduled and standardized expert patients programme course"}], 'interventions': [{'name': 'Diabetes expert patients programme', 'type': 'BEHAVIORAL', 'description': 'Nine-weekly informative and educational sessions by a teaching patient who has experience on diabetes', 'armGroupLabels': ['Diabetes expert patients programme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08007', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pere Roura-Poch, MD, MPH', 'role': 'CONTACT', 'email': 'proura@chv.cat'}, {'name': 'Asunción González-Mestre, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paloma Amil, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claustre Solé, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ester Gil, RN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Catalan Health Institute, Barcelona District health Authority', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'state': 'Catalonia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pere Roura-Poch, MD, MPH', 'role': 'CONTACT', 'email': 'proura@chv.cat'}, {'name': 'Rosa M García-Cerdán, RN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Catalan Health Institute, Sud metropolitan District health Authority', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08272', 'city': 'Sant Fruitós de Bages', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pere Roura-Poch, MD, MPH', 'role': 'CONTACT', 'email': 'proura@chv.cat', 'phone': '+34.93.693.00.40'}, {'name': 'Carme Boix, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pere Roura-Poch, MD, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dolores Álamo-Junquera, MD, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Núria Sala, RN, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joan P Millet, MD, MPH, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joan Tobías, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marta A Palou, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Montserrat Sallés, RN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Catalan Health Institute, Catalonia midlands District health Authority', 'geoPoint': {'lat': 41.75, 'lon': 1.86667}}], 'centralContacts': [{'name': 'Pere Roura-Poch, MD, MPH', 'role': 'CONTACT', 'email': 'proura@chv.cat', 'phone': '+34.93.693.00.40'}, {'name': 'Dolores Álamo-Junquera, MD, MPH', 'role': 'CONTACT', 'email': 'mdalamo.cc.ics@gencat.cat', 'phone': '+34.93.693.00.40'}], 'overallOfficials': [{'name': 'Carme Boix, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catalan Institute of Health'}, {'name': 'Pere Roura-Poch, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Catalan Institute of Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': 'Catalan Institute of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}