Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-07 @ 11:55 AM
Study NCT ID:
NCT01668394
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2012-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Learning and Coping Strategies in Cardiac Rehabilitation - Group Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D000097813', 'term': 'Coping Skills'}, {'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 825}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-09', 'studyFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to cardiac rehabilitation', 'timeFrame': 'After 8 weeks of cardiac rehabilitation'}, {'measure': 'Morbidity and mortality', 'timeFrame': 'Three or four years after last patient into trial'}], 'secondaryOutcomes': [{'measure': 'Risk- and lifestyle factors', 'timeFrame': 'At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation'}, {'measure': 'Health related Quality of life', 'timeFrame': 'At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation'}, {'measure': 'Return to work', 'timeFrame': 'at baseline and after one year', 'description': 'Four weeks of self support at follow up derived from the Danish Register for Evaluation of Marginalisation (DREAM)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '25495543', 'type': 'BACKGROUND', 'citation': 'Lynggaard V, May O, Beauchamp A, Nielsen CV, Wittrup I. LC-REHAB: randomised trial assessing the effect of a new patient education method--learning and coping strategies--in cardiac rehabilitation. BMC Cardiovasc Disord. 2014 Dec 13;14:186. doi: 10.1186/1471-2261-14-186.'}, {'pmid': '29783942', 'type': 'DERIVED', 'citation': 'Bitsch BL, Nielsen CV, Stapelfeldt CM, Lynggaard V. Effect of the patient education - Learning and Coping strategies - in cardiac rehabilitation on return to work at one year: a randomised controlled trial show (LC-REHAB). BMC Cardiovasc Disord. 2018 May 21;18(1):101. doi: 10.1186/s12872-018-0832-2.'}, {'pmid': '28259552', 'type': 'DERIVED', 'citation': 'Lynggaard V, Nielsen CV, Zwisler AD, Taylor RS, May O. The patient education - Learning and Coping Strategies - improves adherence in cardiac rehabilitation (LC-REHAB): A randomised controlled trial. Int J Cardiol. 2017 Jun 1;236:65-70. doi: 10.1016/j.ijcard.2017.02.051. Epub 2017 Feb 21.'}, {'pmid': '26412226', 'type': 'DERIVED', 'citation': 'Dehbarez NT, Lynggaard V, May O, Sogaard R. Learning and coping strategies versus standard education in cardiac rehabilitation: a cost-utility analysis alongside a randomised controlled trial. BMC Health Serv Res. 2015 Sep 28;15:422. doi: 10.1186/s12913-015-1072-0.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25495543', 'label': 'BMC Cardiovascular Disorders'}]}, 'descriptionModule': {'briefSummary': 'Background: It is well known that cardiac rehabilitation has potential to reduce morbidity and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the effect of a new patient education method called learning and coping strategies to that of standard care.\n\nDesign: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly hospitalised with either ischaemic heart disease or heart failure.\n\nSetting: Three hospital Units in Central Denmark Region. Intervention: Cardiac rehabilitation with addition of learning and coping strategies which include participation of experienced patients as co-educators, clarifuing interviews, and inductive teaching style.\n\nControl arm: Standard care cardiac rehabilitation with a decuctive teaching style.\n\nOutcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors, lifestyle, health related quality of life, return to work.', 'detailedDescription': "Coronary heart disease is one the most common cause of death in Denmark and is also a chronic disease that 300,000 people in the country are living with. Cardiac rehabilitation is of great significance for this group of people because of its potential to reduce mortality and morbidity. However, not all patients succeed in changing their lifestyle in a positive and heart healthy direction. Thus, it is a great challenge to develop new methods which can help the patients to maintain a more healthy lifestyle in the long run. A concept for patient education, called learning and coping, has been developed in Norway. It is a health education method based on a high degree of involvement from the participants and on what is important for them. Planning, performance and evaluation happens in close cooperation between the health staff and so-called experienced patients. The course begins and ends with individual clarifying interviews.\n\nThe aim of this study is to evaluate the effect of learning and coping strategies in cardiac rehabilitation on adherence, risk factors and lifestyle, morbidity and mortality, health related quality of life and return to work.\n\nThe number of participants needed are estimated to 750 ptt.s with datacollection at baseline, just after rehabilitation, 3 months after rehabilitation and 3 years after rehabilitation. It is carried out as an open randomised controlled parallel group study in three hospitals in Hospital Unit West Jutland, Central Denmark Region, where the participants newly hospitalised with either ischemic heart disease or heart failure is randomised to either the intervention group with learning and coping strategies or to the standard group without the strategies. The rehabilitation courses in both groups last for eight weeks and consist of both training and education sessions. The concept of learning and coping is applied to the intervention group by letting 'experienced patients' participate in the education and not using standardised teaching slides. Also clarifying individual interviews are completed before and after the course. The 1:1 randomisation is computer generated and is stratified by hospital unit, diagnosis and gender. All analyses will be performed after the principle of 'intention to treat'.\n\nThe primary outcomes are adherence to cardiac rehabilitation, morbidity and mortality, while secondary outcomes are risk factors (blood pressure and lipid profile), lifestyle (body mass index, waist circumference, smoking status, exercise capacity and body compositions measured via DXA-scans) and health related quality of life (SF-12, Health Education Impact Questionnaire and Major Depression Inventory) and return to work (derived from the Danish Register for Evaluation of Marginalisation, (DREAM))"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients above 18 years hospitalised with ichemic heart disease or heart failure motivated for completing a rehabilitation course\n\nExclusion Criteria:\n\n* acute coronary syndrome less than five days before randomisation,\n* active peri-, myo- or endocarditis,\n* untreated symptomatic valvular disease,\n* hypertension with systolic pressure over 200 mmHg and/or diastolic pressure over 110 mmHg,\n* other extracardiac disease,\n* planned revascularization,\n* senile dementia,\n* known compliance and former participation in the study.\n\nExclusion Criteria for outcome on return to work:\n\n* age above 60 years\n* recieving public transfer payments related to permanent work incapacity at week of inclusion.'}, 'identificationModule': {'nctId': 'NCT01668394', 'acronym': 'LC-REHAB', 'briefTitle': 'Effect of Learning and Coping Strategies in Cardiac Rehabilitation - Group Study', 'organization': {'class': 'OTHER', 'fullName': 'Herning Hospital'}, 'officialTitle': 'Effect of Learning and Coping Strategies in Cardiac Rehabilitation - A Randomised Controlled Parallel Group Study', 'orgStudyIdInfo': {'id': 'Ethics app. number: 20100230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Learning and coping arm', 'description': 'Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.', 'interventionNames': ['Behavioral: Learning and coping arm']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'Usual care. Teaching style: deductive.', 'interventionNames': ['Other: Control arm']}], 'interventions': [{'name': 'Learning and coping arm', 'type': 'BEHAVIORAL', 'otherNames': ['Learning and coping strategies in cardiac rehabilitation'], 'description': 'Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.', 'armGroupLabels': ['Learning and coping arm']}, {'name': 'Control arm', 'type': 'OTHER', 'otherNames': ['Standard cardiac rehabilitation'], 'description': 'Usual care. Teaching style: deductive.', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Regional Hospital West Jutland', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Vibeke Lynggaard, MHsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional Hospital West Jutland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herning Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MHsc, PhD student at Cardiovasculat Research Unit', 'investigatorFullName': 'Vibeke Lynggaard', 'investigatorAffiliation': 'Herning Hospital'}}}}