Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT01612520
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2012-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telecoaching of People With Type 2 Diabetes in Primary 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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 574}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the absolute change in HbA1c', 'timeFrame': 'baseline; 6 months and 18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['type 2 Diabetes Mellitus', 'telenursing', 'RCT', 'economic analysis'], 'conditions': ['Type 2 Diabetes Mellitus', 'Telenursing']}, 'referencesModule': {'references': [{'pmid': '27825340', 'type': 'DERIVED', 'citation': 'Odnoletkova I, Buysse H, Nobels F, Goderis G, Aertgeerts B, Annemans L, Ramaekers D. Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomised clinical trial. BMC Med Inform Decis Mak. 2016 Nov 9;16(1):142. doi: 10.1186/s12911-016-0383-3.'}, {'pmid': '27727281', 'type': 'DERIVED', 'citation': 'Odnoletkova I, Ramaekers D, Nobels F, Goderis G, Aertgeerts B, Annemans L. Delivering Diabetes Education through Nurse-Led Telecoaching. Cost-Effectiveness Analysis. PLoS One. 2016 Oct 11;11(10):e0163997. doi: 10.1371/journal.pone.0163997. eCollection 2016.'}, {'pmid': '24495633', 'type': 'DERIVED', 'citation': 'Odnoletkova I, Goderis G, Nobels F, Aertgeerts B, Annemans L, Ramaekers D. Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial. BMC Fam Pract. 2014 Feb 4;15:24. doi: 10.1186/1471-2296-15-24.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with type 2 diabetes between 18 and 75 years old on the day of the selection\n\nExclusion Criteria:\n\n* Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer)\n* Residents of long term care facilities\n* Pregnancy\n* Incapable of telephone communication in Dutch'}, 'identificationModule': {'nctId': 'NCT01612520', 'briefTitle': 'Telecoaching of People With Type 2 Diabetes in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'orgStudyIdInfo': {'id': 'S53665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'telecoaching', 'interventionNames': ['Behavioral: telecoaching']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'telecoaching', 'type': 'BEHAVIORAL', 'description': "The COACH program trains patients to 'drive' the process of achieving and maintaining the target levels for their risk factors while working in association with their GP. The telephone coaching is aimed at improving self-efficacy by adhering to the prescribed therapy and making relevant behavior changes.\n\nThe coaching model is a continuous five-stage coaching cycle: Stage 1. Finding out what the patient knows; Stage 2. Telling the patient what they should know; Stage 3. Assertiveness training; Stage 4. Setting an action plan; Stage 5. Reassessment at the next coaching session (monitoring).\n\nThe coach monitors and registers: the biomedical risk factors, the lifestyle/behavioral risk factors and use of the recommended medications. Coaching is focused on eliminating the knowledge gap and motivating the patient to apply the appropriate lifestyle and medical therapy.", 'armGroupLabels': ['telecoaching']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student in Biomedical sciences', 'investigatorFullName': 'Irina Odnoletkova', 'investigatorAffiliation': 'KU Leuven'}}}}