Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT00705302
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2008-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Education in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Effect and Costs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012657', 'term': 'Self-Help Groups'}, {'id': 'D012681', 'term': 'Sensitivity Training Groups'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-10', 'studyFirstSubmitDate': '2008-06-24', 'studyFirstSubmitQcDate': '2008-06-25', 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "St. George's Respiratory Questionnaire (SGRQ) - Total score", 'timeFrame': 'Baseline, 3, 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Modified Borg scale (MBS) pre, during and post 6MWT', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Patient Activation Measure (PAM)', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'The Perceived Quality of Life Scale', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': '6 minute walk test (6MWT)', 'timeFrame': 'Baseline, 3, 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'Outpatient', 'Patient education', 'Pulmonary rehabilitation', 'Self-management'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '18268936', 'type': 'BACKGROUND', 'citation': 'Lomundal BK, Steinsbekk A. Observational studies of a one year self-management program and a two year pulmonary rehabilitation program in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2007;2(4):617-24.'}, {'pmid': '22371649', 'type': 'BACKGROUND', 'citation': 'Lomundal BK, Steinsbekk A. Five-year follow-up of a one-year self-management program for patients with COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:87-93. doi: 10.2147/COPD.S27352. Epub 2012 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the long term effect of a self-help group in a patient education program for patients with chronic obstructive pulmonary disease (COPD).', 'detailedDescription': 'Pulmonary rehabilitation is aimed to increase the level of health of patients with COPD by increasing their self care ability. A recent updated systematic review concluded that evidence strongly supports respiratory rehabilitation as part of the spectrum of management of patients with chronic obstructive pulmonary disease (COPD). Studies of pulmonary rehabilitation programs lasting up to 18 months show that effects are mainly maintained throughout the duration of the program. The long term effect, however, is mostly studied for programs of shorter durations. Some of the studies with shorter duration have found that the achieved benefit was lost or diminished during the follow up period, while others have found that the effect has been maintained up to 18 months. Our necessity in the rehabilitative field is to find strategies to maintain benefits during time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (FEV1) lower that 75% of predicted\n* the ability to participate in physical activity\n* not been hospitalized the last month.\n\nExclusion Criteria:\n\n* contraindications for physical activity'}, 'identificationModule': {'nctId': 'NCT00705302', 'briefTitle': 'Patient Education in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Effect and Costs', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'A Randomised Controlled Trial of the Effect of a Patient Education Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '10307300'}, 'secondaryIdInfos': [{'id': '17732', 'type': 'OTHER', 'domain': 'NSD'}, {'id': '4.2007.2589', 'type': 'OTHER', 'domain': 'REK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient education including self-help', 'description': 'Patients in the arm will participate in a three months patient education and exercise program including a self-help group in 3 months of time.', 'interventionNames': ['Behavioral: Group training with self-help group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patient education', 'description': 'Patients in arm 2 will participate in the same patient education and exercise program as arm 1, but without an additional self-help group.', 'interventionNames': ['Behavioral: Group training']}], 'interventions': [{'name': 'Group training with self-help group', 'type': 'BEHAVIORAL', 'description': 'Combined educational and exercise program for pulmonary rehabilitation, with (1) or without(2 a self-help group. The educational part consists firstly of two days with group meetings with information from medical doctor, pharmacist, psychologist, ergonomist, nurse, social worker, physiotherapist and a clinical nutritional physiologist. One more day will be held after 3 months and it is the participants themselves who decide on the content of these days. An experienced patient will participate throughout the course. The exercise part consists of group training twice a week for 3 months with 10-15 participants in each group. Patients will instead of five of the group training sessions, participate in a self-help group.', 'armGroupLabels': ['patient education including self-help']}, {'name': 'Group training', 'type': 'BEHAVIORAL', 'description': 'Combined educational and exercise program for pulmonary rehabilitation. The educational part consists firstly of two days with group meetings with information from medical doctor, pharmacist, psychologist, ergonomist, nurse, social worker, physiotherapist and a clinical nutritional physiologist. One more day will be held after 3 months and it is the participants themselves who decide on the content of these days. An experienced patient will participate throughout the course. The exercise part consists of group training twice a week for 3 months with 10-15 participants in each group.', 'armGroupLabels': ['patient education']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Public Health and General Practice, Norwegian University of Science and Technology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Aslak Steinsbekk, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Technology and Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}