Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT00989456
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-10-02', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Sustainability of the physiological effects of muscular training (6 Minutes Walk)', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary disease', 'Heart failure', 'Stroke', 'quality of life', 'self management education', 'physical exercise', 'primary health care'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Heart Failure', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '25380808', 'type': 'BACKGROUND', 'citation': "Solberg HS, Steinsbekk A, Solbjor M, Granbo R, Garasen H. Characteristics of a self-management support programme applicable in primary health care: a qualitative study of users' and health professionals' perceptions. BMC Health Serv Res. 2014 Nov 8;14:562. doi: 10.1186/s12913-014-0562-9."}]}, 'descriptionModule': {'briefSummary': 'This study addresses self management and maintenance of health through evaluation of a program of patient education in combination with physical training and with a structured follow-up.\n\nIt is hypothesized that such a program will:\n\n1. improve quality of life, physical functioning, coping in everyday-life\n2. reduce hospitalization and (re-)admissions for patients with chronic disease, reduce consumption of home care services and can increase consumption of general practice and physiotherapy services in primary health care.\n3. improve patient satisfaction and health care providers satisfaction', 'detailedDescription': 'Patients with chronically, long-lasting illness, have complex needs for treatment and care, which none of the service providers can fulfill on their own. Both patients and their relatives are in danger of experiencing severe lack of quality. Integrated care path programs are increasingly put into use. There is insufficient research-based documentation of the effect of such care paths.\n\nThe available documentation of different integrated care paths emphasizes early mobilization and discharge, rehabilitation in familiar surroundings, more effective communication and exchange of competence between the different service providers and educational self-management for patients as main elements in order to expect effect.\n\nThere are no studies that evaluate the effect of quality of life, functional skills and personal coping if group-based educational self management is combined with physical exercise and patients with different chronically illnesses participate in the same group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 45 years of age or more\n* Living at home\n* Capable of active participation in a group setting\n* Walking distance within 550 meter in 6 minutes\n* Chronic obstructive pulmonary disease (COPD) I-III\n* Chronic heart disease I-III\n* Stroke(0-2 on Modified Rankin Scale)\n\nExclusion Criteria:\n\n* Speaking and language problems or other substantial communication problems\n* Unstable medical or social situation\n* Participation in another science study'}, 'identificationModule': {'nctId': 'NCT00989456', 'briefTitle': 'Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Structured Patient Education in Combination With Physical Exercise as Part of the Integrated Care to Chronically Ill Patients With Chronic Obstructive Pulmonary Disease, Heart Failure and Stroke. A Randomized Controlled Intervention Trial.', 'orgStudyIdInfo': {'id': '420082351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise and education', 'description': 'Supervised physical exercise in groups, plus a self management education programme (patient education).', 'interventionNames': ['Behavioral: Self management education programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'exercise only', 'description': 'Supervised physical exercise in groups.', 'interventionNames': ['Behavioral: exercise only']}], 'interventions': [{'name': 'Self management education programme', 'type': 'BEHAVIORAL', 'description': 'The structured patient educational self - management programme consists of 6 weekly sessions à 2 hours. The educational programme will take place prior to one of the two weekly training sessions.\n\nAfter the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care. During the last month of the intervention year educational self - management will be offered twice and focus on themes that the participants wish to refresh.', 'armGroupLabels': ['exercise and education']}, {'name': 'exercise only', 'type': 'BEHAVIORAL', 'description': '6 week waiting list, followed by two weekly training sessions. After the initial period of 8 weeks participants are encouraged to practicing self- management on their own for a period of 9 months. They receive,in addition to standard follow - up, an offer of extra follow - up consisting of regular contact with their group supervisors in primary health care.', 'armGroupLabels': ['exercise only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6600', 'city': 'Sunndal', 'state': 'Møre Og Romsdal County', 'country': 'Norway', 'facility': 'Sunndal Municipality', 'geoPoint': {'lat': 61.93333, 'lon': 5.65}}, {'zip': '6650', 'city': 'Surnadal', 'state': 'Møre Og Romsdal County', 'country': 'Norway', 'facility': 'Surnadal municipality', 'geoPoint': {'lat': 62.97397, 'lon': 8.72472}}, {'zip': '7540', 'city': 'Klæbu', 'state': 'Sør - Trøndelag', 'country': 'Norway', 'facility': 'Klæbu Municipality', 'geoPoint': {'lat': 64.08024, 'lon': 11.7357}}, {'zip': '7000', 'city': 'Trondheim', 'state': 'Sør Trøndelag County', 'country': 'Norway', 'facility': 'Trondheim Municipality', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'zip': '7240', 'city': 'Hitra', 'state': 'Sør-Trøndelag County', 'country': 'Norway', 'facility': 'Hitra Municipality', 'geoPoint': {'lat': 63.63333, 'lon': 8.73333}}], 'overallOfficials': [{'name': 'Helge Garåsen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Research Council of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}