Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT00552903
Status:
UNKNOWN
Last Update Posted:
2009-02-04
First Post:
2007-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003327', 'term': 'Coronary Disease'}], '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'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2007-11-01', 'studyFirstSubmitQcDate': '2007-11-01', 'lastUpdatePostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women)', 'timeFrame': '12 months from start of intervention'}, {'measure': 'For patients with diabetes: blood HbA1c at target level (7% or less)', 'timeFrame': '12 months from start of intervention'}], 'secondaryOutcomes': [{'measure': 'Improvement in body mass index, health-related quality of life (15D instrument), amount of exercise, diet, smoking cessation; for patients with heart failure also use of emergency services and NYHA class', 'timeFrame': '12 months from start of intervention'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Heart Failure', 'Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '34781936', 'type': 'DERIVED', 'citation': 'Mustonen E, Horhammer I, Patja K, Absetz P, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching. BMC Health Serv Res. 2021 Nov 15;21(1):1237. doi: 10.1186/s12913-021-07263-w.'}, {'pmid': '31884682', 'type': 'DERIVED', 'citation': 'Mustonen E, Horhammer I, Absetz P, Patja K, Lammintakanen J, Talja M, Kuronen R, Linna M. Eight-year post-trial follow-up of health care and long-term care costs of tele-based health coaching. Health Serv Res. 2020 Apr;55(2):211-217. doi: 10.1111/1475-6773.13251. Epub 2019 Dec 29.'}, {'pmid': '28202032', 'type': 'DERIVED', 'citation': 'Oksman E, Linna M, Horhammer I, Lammintakanen J, Talja M. Cost-effectiveness analysis for a tele-based health coaching program for chronic disease in primary care. BMC Health Serv Res. 2017 Feb 15;17(1):138. doi: 10.1186/s12913-017-2088-4.'}, {'pmid': '22682298', 'type': 'DERIVED', 'citation': 'Patja K, Absetz P, Auvinen A, Tokola K, Kyto J, Oksman E, Kuronen R, Ovaska T, Harno K, Nenonen M, Wiklund T, Kettunen R, Talja M. Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from The TERVA randomized controlled trial. BMC Health Serv Res. 2012 Jun 10;12:147. doi: 10.1186/1472-6963-12-147.'}]}, 'descriptionModule': {'briefSummary': 'A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes (medication and HbA1c\\>7% and no cardiovascular disease), coronary artery disease (history of myocardial infarction or revascularisation) or heart failure (NYHA II-III and admitted in a hospital for the condition within 2 years)\n* Aged 45 years or older\n* Resident in the Päijät-Häme health care district\n\nExclusion Criteria:\n\n* Classified as ineligible by primary care physician\n* Unable to co-operate or participate in health coaching\n* Major elective surgery planned within 6 months\n* History of major surgery within past 2 years\n* Life expectancy \\<1 year\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00552903', 'acronym': 'TerVa', 'briefTitle': 'Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Paijat-Hame Hospital District'}, 'officialTitle': 'Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease', 'orgStudyIdInfo': {'id': 'PHKS-Z80'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Active intervention - personal health coaching provided', 'interventionNames': ['Behavioral: Health coaching']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Control arm - no intervention, data on health outcomes collected at baseline (entry to the study) and during the 12 month follow-up'}], 'interventions': [{'name': 'Health coaching', 'type': 'BEHAVIORAL', 'otherNames': ['Counseling, health education'], 'description': 'Personal health coach providing advice and counselling by telephone, weekly contacts', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15850', 'city': 'Lahti', 'country': 'Finland', 'facility': 'Päijät-Hämeen Sosiaali - ja Terveysyhtymä', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}], 'overallOfficials': [{'name': 'Martti Talja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Päijät Häme Central Hospital'}, {'name': 'Ilmo Parvinen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sitra, the Finnish Innovation Fund'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paijat-Hame Hospital District', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sitra, the Finnish Innovation Fund', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Tampere University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Martti Talja', 'oldOrganization': 'Päijät-Häme Health and Welfare Trust'}}}}