Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-31 @ 2:51 PM
Study NCT ID:
NCT00969020
Status:
COMPLETED
Last Update Posted:
2012-10-24
First Post:
2009-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-22', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-08-28', 'lastUpdatePostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EQ5D', 'timeFrame': '12 months'}, {'measure': 'LOS', 'timeFrame': 'up to 5 days', 'description': 'Length of Stay'}], 'secondaryOutcomes': [{'measure': 'SCL-90-r', 'timeFrame': 'day 0', 'description': 'psychological problems and symptoms of psychopathology'}, {'measure': 'TUG', 'timeFrame': 'day 90', 'description': 'Time up and go'}, {'measure': 'anxiety', 'timeFrame': 'Day 90', 'description': 'VAS - anxiety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Length of stay', 'Timed up and go'], 'conditions': ['Quality of Life', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The RRS project is a Randomized Clinical Trial documenting the effect of Remote Rehabilitation and Support via a telemedicine solution for patients undergoing an optimized fast-track orthopedic surgery procedure with the implementation of a total hip arthroplasty. With the telemedicine solution the investigators will support and try to motivate the patient to be discharged after only one day of hospitalization.', 'detailedDescription': 'This PhD study evaluates the effect of an information technology solution containing RRS. The way it supports, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.\n\nThe parameters evaluated will be: Length of stay, health-related quality-of-life (HRQOL), functional outcome, pain, anxiety, complications and an evaluation of the socio-economic effect.\n\nThe aim of the study generates the following hypotheses and focus for publication\n\n* Length of stay is lower for the intervention group compared to the control group.\n* The average quality of life measured with EQ-5D will either be the same or higher when comparing the intervention group with the control group.\n* Compared to the control group the functional outcome of the intervention group measured with Oxford Hip Score (OHS) and Timed Up and Go (TUG) will be the same or better.\n* Complications measured as luxations, infections, and reoperations are the same or lower in the intervention group compared to the control group.\n* There will be a correlation between patients with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG.\n* There will be a correlation between support persons with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG for the patient they are related to.\n* The socio-economic costs will be lower for the intervention group compared to the control group based on self reported data and data collected from official databases. This study will be conducted as a piggy back to the RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients qualified to go trough at joint-care procedure after the guidelines from Regionshospitalet Silkeborg.\n\nExclusion Criteria:\n\n* Previous hip surgery with the implantation of a total hip arthroplasty.\n* Patients living more than approximately 60 kilometers from the Regionshospitalet Silkeborg.\n* Patients with no 3G tele-net at their home address.\n* Patients with the need of Danish interpretation.'}, 'identificationModule': {'nctId': 'NCT00969020', 'acronym': 'RRS', 'briefTitle': 'A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Silkeborg'}, 'officialTitle': 'The Effect of Remote Rehabilitation Support Via a Telemedicine Solution for Patients Undergoing an Optimized Fast-track Orthopedic Surgery Procedure With the Implementation of a Total Hip Arthroplasty.', 'orgStudyIdInfo': {'id': '2009-RSI-RRS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Telemedicine', 'description': 'RRS via telemedicine. By developing the concept of Remote Rehabilitation Support (RRS) the investigators will try to bring preoperative education of the patient, dissemination of information and postoperative support to a new level.', 'interventionNames': ['Procedure: remote rehabilitation support']}, {'type': 'NO_INTERVENTION', 'label': 'Standard', 'description': 'The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery'}], 'interventions': [{'name': 'remote rehabilitation support', 'type': 'PROCEDURE', 'otherNames': ['Rehabilitation', 'Fast-track'], 'description': 'An information technology solution containing RRS. The way it supports,, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.', 'armGroupLabels': ['Telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8600', 'city': 'Silkeborg', 'state': 'Silkeborg', 'country': 'Denmark', 'facility': 'Regionshospitalet SIlkeborg', 'geoPoint': {'lat': 56.1697, 'lon': 9.54508}}], 'overallOfficials': [{'name': 'Kjeld Soballe, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Aarhus, Orthopaedic surgical research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionshospitalet Silkeborg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Caretech Innovation', 'class': 'UNKNOWN'}, {'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Martin Vesterby', 'investigatorAffiliation': 'Regionshospitalet Silkeborg'}}}}