Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-29 @ 1:54 AM
Study NCT ID:
NCT01425866
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Years Maintenance of Structured Group Self-management Education in Type 2 Diabetes : a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2011-08-26', 'studyFirstSubmitQcDate': '2011-08-29', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in glycated haemoglobin (GlyHb)', 'timeFrame': '0 and 2 years'}], 'secondaryOutcomes': [{'measure': 'Mean change in glycated haemoglobin (GlyHb)', 'timeFrame': '0 and 1 year'}, {'measure': 'change in GlyHb', 'timeFrame': 'quarterly up to 2 yrs'}, {'measure': 'Blood sugar and lipids', 'timeFrame': '1 and 2 yrs', 'description': 'Blood sugar Total, HDL and LDL cholesterol, triglycerides'}, {'measure': 'diabetes complications', 'timeFrame': '1 and 2 yrs', 'description': 'retinopathy stages, micro-albuminuria or proteinuria, creatinine clearance, foot risk grade, ischemic heart or cerebral disease'}, {'measure': 'health behaviours', 'timeFrame': '1 and 2 yrs', 'description': 'physical activity and diet (Baecke and food frequency questionnaires)'}, {'measure': 'anti-diabetic therapy', 'timeFrame': '1 and 2 yrs', 'description': 'type, dosage'}, {'measure': 'health care process', 'timeFrame': '1 and 2 yrs', 'description': 'medical follow-up and appointments, compliance (questionnaire)'}, {'measure': 'Psychometric scales', 'timeFrame': '1 and 2 yrs', 'description': 'self-efficacy, social support, HAD (anxiety and depression)'}, {'measure': 'Quality of Life', 'timeFrame': '1 and 2 yrs', 'description': 'short DQOL adapted and validated for Reunion'}, {'measure': 'Change in tobacco consumption', 'timeFrame': 'quarterly up to 2 yrs'}, {'measure': 'Change in fasting blood glucose', 'timeFrame': 'quarterly up to 2 yrs'}, {'measure': 'Change in body mass index', 'timeFrame': 'quarterly up to 2 yrs'}, {'measure': 'Change in waist circumference', 'timeFrame': 'quarterly up to 2 yrs'}, {'measure': 'Change in blood pressure', 'timeFrame': 'quarterly up to 2 yrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Structured self-management education', 'Therapeutic patient education', 'Lifestyle changes', 'Self-management Blood glucose', 'Empowerment', 'Adult learning', 'Socio-constructivism', 'Health management network', 'Reunion island'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '36510180', 'type': 'DERIVED', 'citation': 'Flaus-Furmaniuk A, Fianu A, Lenclume V, Chirpaz E, Balcou-Debussche M, Debussche X, Marimoutou C. Attrition and social vulnerability during 2-year-long structured care in type 2 diabetes, the ERMIES randomized controlled trial. BMC Endocr Disord. 2022 Dec 13;22(1):314. doi: 10.1186/s12902-022-01211-3.'}, {'pmid': '35701054', 'type': 'DERIVED', 'citation': 'Debussche X, Balcou-Debussche M, Ballet D, Caroupin-Soupoutevin J. Health literacy in context: struggling to self-manage diabetes - a longitudinal qualitative study. BMJ Open. 2022 Jun 14;12(6):e046759. doi: 10.1136/bmjopen-2020-046759.'}, {'pmid': '22856504', 'type': 'DERIVED', 'citation': 'Debussche X, Collin F, Fianu A, Balcou-Debussche M, Fouet-Rosiers I, Koleck M, Favier F. Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island. Cardiovasc Diabetol. 2012 Aug 2;11:91. doi: 10.1186/1475-2840-11-91.'}]}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical trials have clearly demonstrated that a better control of blood glucose level and of other risk factors is efficient in preventing or retarding the complications of the disease. On Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured group self-management education maintained at the community level for 2 years in patients with insufficiently controlled type 2 diabetes has better metabolic results (as attested by improvement in HbA1c level) at 2 yrs, compared to an initial short term (\\< 3 months) self-management program, based on the same theoretical basis and framework (learning nests empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to 2 intervention arms: either a short term (\\< 3 months) program (1 to 7 thematic 2-hr long sessions depending on individual assessment), or a long term program including the same initial program as 1st arm, but with group self management education sessions, maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed). Medical visits will be held quarterly for the recording of outcome measures (HbA1c, blood pressure, anthropometrics, tobacco consumption, diabetes complications) and yearly for blood glucose, lipids, micro-albuminuria or proteinuria, creatinine clearance, diet and exercise (questionnaires), treatment recording, quality of life, self-efficacy, anxiety and depression scales, and social support.', 'detailedDescription': 'Randomised clinical trial comparing 2 parallel arms of educational intervention with the hypothesis of the superiority of a 2-year maintenance of a structured, theoretically-based, educational follow-up. All subjects of both arms will beneficiate from an initial structured educational program (\\< 3-months). Subjects, educators, and investigators will be unaware of the group allocation during this initial round. Then the intervention arm will undergo a 2 years self management educational follow-up program. Randomisation will be stratified on 2 factors : centres (5 strata) and anti diabetic treatment (2 strata: insulin-treated or not). All group sessions (3-10 subjects, 2 hr-long, one assessment group session and 6 facultative additional specific sessions for each round \\[initial in both arms or follow-up in the intervention arm\\], as needed and planned during the first) will be held at the community level, as closer as possible to the subjects\' residence. Educators are specifically trained and the educational sessions are structured and coordinated in the framing and organisational supervision of the health management network "ReuCARE" in Reunion island. Subjects of both arms will continue quarterly to attend at the outpatient clinic of the centre. This trial is associated to a qualitative ethno-sociological study on a sample of 30-40 subjects, with in-depth interviews and ethnographic observation of group sessions, with the specific aim of describing the learning processes, coping, health and functional literacy, social and contextual issues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* HbA1c ≥ 7,5% more than 3 months\n* Adults\n* ≥ 1 year ADO and/or insulin and/or GLP-1 analog\n* antidiabetic treatment unchanged since 3 months (no change of treatment in the last 3 months, except for insulin dosage)\n* Living in Reunion Island\n* Affiliated to French national health insurance\n* Signed informed consent\n\nExclusion Criteria:\n\n* Treatment or associated conditions that would influence glycemic control, such as corticotherapy, cancer, inflammatory chronic diseases\n* Hospitalisation linked to diabetes \\< 3 months\n* Structured patient education in the past 3 months\n* Severe diabetes complications (e.g. ischemic or proliferative retinopathy, severe renal failure (clearance \\< 15 ml/min), acute ischemic heart disease (\\< 6 months, foot lesion)\n* Pregnancy (on-going or planned during the study)\n* Evolutive cancer\n* Physical or cognitive heavy handicap\n* Concomitant participation to a therapeutic trial'}, 'identificationModule': {'nctId': 'NCT01425866', 'acronym': 'ERMIES', 'briefTitle': 'Two Years Maintenance of Structured Group Self-management Education in Type 2 Diabetes : a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island', 'orgStudyIdInfo': {'id': '2010/CHR/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 years self management education', 'description': 'Long-term program including initial self-management education program (1 to 7 sessions, based on individual assessment), and follow-up group sessions maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed).', 'interventionNames': ['Behavioral: Structured self-management group education during 2 years']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Initial self-management education', 'description': 'Initial self-management group education: 1 to 7 sessions (\\< 3 months), based on individual assessment.', 'interventionNames': ['Behavioral: Structured self-management group education during 2 years']}], 'interventions': [{'name': 'Structured self-management group education during 2 years', 'type': 'BEHAVIORAL', 'description': 'After an initial intensive group education, four-monthly follow-up self-management group education sessions for 2 years. Each session is based on empowerment, socio-constructivism, social learning theory: personalized assessment (BG and risk factors, actions: realized, planned, achieved (or not), cognitive work, analysis of individual and social context and environment (facilitators, obstacles) then action planning. Specific additional sessions can be scheduled (food management, diabetes treatment and hypoglycemia, exercise, self monitoring of BG, insulin dosage, foot care). Sessions are framed, and structured, with patient booklet support. Sessions are delivered at the community level, by trained registered nurses, under the coordination of the health management network Reucare.', 'armGroupLabels': ['2 years self management education', 'Initial self-management education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97470', 'city': 'Saint-Benoît', 'state': 'La Réunion', 'country': 'France', 'facility': 'Groupe Hopitalier Est Réunion', 'geoPoint': {'lat': 46.55025, 'lon': 0.34177}}, {'zip': '97863', 'city': 'Saint-Paul', 'state': 'La Réunion', 'country': 'France', 'facility': 'Centre Hospitalier Gabriel Martin', 'geoPoint': {'lat': 49.42962, 'lon': 2.00755}}, {'zip': '97448', 'city': 'Saint-Pierre', 'state': 'La Réunion', 'country': 'France', 'facility': 'Diabetolgy - UNiversity Hospital Sud Réunion', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'zip': '97405', 'city': 'Saint Denis de La Réunion', 'country': 'France', 'facility': 'Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site'}], 'overallOfficials': [{'name': 'Xavier Debussche, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetology - University Hospital Reunion Island - Felix Guyon Site'}, {'name': 'Jean Luc YVIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine - University Hospital Reunion Island - Felix Guyon Site'}, {'name': 'Stéphane SCHNEEBELI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetology - University Hospital Reunion Island - GHSR'}, {'name': 'Jean Hugues GATINA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Gabriel Martin'}, {'name': 'Yogananda THIRAPATHIAPPADU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Hospitalier Est Réunion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}