Nctid:
NCT06235502
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000051346", "term"=>"Mobility Limitation"}], "browseLeaves"=>[{"id"=>"M26689", "name"=>"Mobility Limitation", "asFound"=>"Mobility Limitation", "relevance"=>"HIGH"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "relevance"=>"LOW"}, {"id"=>"M23449", "name"=>"Pulmonary Disease, Chronic Obstructive", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T6034", "name"=>"Quality of Life", "asFound"=>"Quality of Life", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"], "maskingDescription"=>"Participants are anonymised with a participant identification"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Randomized Controlled Trial"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-09-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-30", "studyFirstSubmitDate"=>"2023-05-01", "studyFirstSubmitQcDate"=>"2024-01-31", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Five-repetition sit-to-stand test", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded"}, {"measure"=>"Five-repetition sit-to-stand test", "timeFrame"=>"Changes from baseline lower limb function at follow-up are assessed at 6 weeks", "description"=>"The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded"}, {"measure"=>"Five-repetition sit-to-stand test", "timeFrame"=>"Changes from baseline lower limb function at follow-up are assessed at 6 months", "description"=>"The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded"}, {"measure"=>"Five-repetition sit-to-stand test", "timeFrame"=>"Changes from baseline lower limb function at follow-up are assessed at 12 months", "description"=>"The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded"}], "secondaryOutcomes"=>[{"measure"=>"Daily Activity Levels", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"Triaxial leg-mounted sensor that assesses time spent standing, walking, running, supine, cycling and sleeping/sedentary continuously throughout the day during post-hospitalisation rehabilitation for 6 weeks."}, {"measure"=>"Daily Activity Levels", "timeFrame"=>"Changes from baseline activity during rehabilitation at follow-up are assessed 12 months", "description"=>"Triaxial leg-mounted sensor that assesses time spent standing, walking, running, supine, cycling and sleeping/sedentary continuously throughout the day during post-hospitalisation rehabilitation for 6 weeks"}, {"measure"=>"Lung function Test (FEV1)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"Forced expiratory volume in the first second in a spirometry"}, {"measure"=>"Lung function Test (FEV1)", "timeFrame"=>"Changes from baseline lung function at follow-up are assessed at 6 weeks", "description"=>"Forced expiratory volume in the first second in a spirometry"}, {"measure"=>"Lung function Test (FEV1)", "timeFrame"=>"Changes from baseline lung function at follow-up are assessed at 6 months", "description"=>"Forced expiratory volume in the first second in a spirometry"}, {"measure"=>"Lung function Test (FEV1)", "timeFrame"=>"Changes from baseline lung function at follow-up are assessed at 12 months", "description"=>"Forced expiratory volume in the first second in a spirometry"}, {"measure"=>"Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea"}, {"measure"=>"Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)", "timeFrame"=>"Changes from baseline and at follow-up are assessed at 6 weeks", "description"=>"A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea"}, {"measure"=>"Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)", "timeFrame"=>"Changes from baseline and at follow-up are assessed at 6 months", "description"=>"A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea"}, {"measure"=>"Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)", "timeFrame"=>"Changes from baseline and at follow-up are assessed at 12 months", "description"=>"A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea"}, {"measure"=>"Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"The 2 part, 50 item questionnaire with scores from 0-100 is used to assess health impairment related to symptoms, activity, impacts, and total in patients with asthma and Chronic Obstructive Pulmonary Disease. Higher scores indicate better health related quality of life."}, {"measure"=>"Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)", "timeFrame"=>"Changes from baseline health related quality of life at follow-up are assessed at 6 weeks", "description"=>"The 2 part, 50 item questionnaire with scores from 0-100 is used to assess health impairment related to symptoms, activity, impacts, and total in patients with asthma and Chronic Obstructive Pulmonary Disease. Higher scores indicate better health related quality of life."}, {"measure"=>"Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)", "timeFrame"=>"Changes from baseline health related quality of life at follow-up are assessed at 6 months", "description"=>"The 2 part, 50 item questionnaire with scores from 0-100 is used to assess health impairment related to symptoms, activity, impacts, and total in patients with asthma and Chronic Obstructive Pulmonary Disease. Higher scores indicate better health related quality of life."}, {"measure"=>"Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)", "timeFrame"=>"Changes from baseline health related quality of life at follow-up are assessed at 12 months", "description"=>"The 2 part, 50 item questionnaire with scores from 0-100 is used to assess health impairment related to symptoms, activity, impacts, and total in patients with asthma and Chronic Obstructive Pulmonary Disease. Higher scores indicate better health related quality of life."}, {"measure"=>"Life-Space Assessment (LSA)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"Measure of performance on a range of tasks, ie. balance (score range = 0-16) and gait (score range = 0-12). Balance and gait scores are summed to produce a total score (range = 0-28) with higher scores indicate a higher degree of mobility."}, {"measure"=>"Life-Space Assessment (LSA)", "timeFrame"=>"Changes from baseline mobility at follow-up are assessed at 6 weeks", "description"=>"Measure of performance on a range of tasks, ie. balance (score range = 0-16) and gait (score range = 0-12). Balance and gait scores are summed to produce a total score (range = 0-28) with higher scores indicate a higher degree of mobility."}, {"measure"=>"Life-Space Assessment (LSA)", "timeFrame"=>"Changes from baseline mobility at follow-up are assessed at 6 months", "description"=>"Measure of performance on a range of tasks, ie. balance (score range = 0-16) and gait (score range = 0-12). Balance and gait scores are summed to produce a total score (range = 0-28) with higher scores indicate a higher degree of mobility."}, {"measure"=>"Life-Space Assessment (LSA)", "timeFrame"=>"Changes from baseline mobility at follow-up are assessed at 12 months", "description"=>"Measure of performance on a range of tasks, ie. balance (score range = 0-16) and gait (score range = 0-12). Balance and gait scores are summed to produce a total score (range = 0-28) with higher scores indicate a higher degree of mobility."}, {"measure"=>"COPD Assessment Test (CAT)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"Measurement of the impact of COPD on a person's life, and how this changes over time. Scale ranging from 5-30 where a higher score indicates a higher impact of COPD."}, {"measure"=>"COPD Assessment Test (CAT)", "timeFrame"=>"Changes from baseline COPD impact at follow-up are assessed at 6 weeks", "description"=>"Measurement of the impact of COPD on a person's life, and how this changes over time. Scale ranging from 5-30 where a higher score indicates a higher impact of COPD."}, {"measure"=>"COPD Assessment Test (CAT)", "timeFrame"=>"Changes from baseline COPD impact at follow-up are assessed at 6 months", "description"=>"Measurement of the impact of COPD on a person's life, and how this changes over time. Scale ranging from 5-30 where a higher score indicates a higher impact of COPD."}, {"measure"=>"COPD Assessment Test (CAT)", "timeFrame"=>"Changes from baseline COPD impact at follow-up are assessed at 12 months", "description"=>"Measurement of the impact of COPD on a person's life, and how this changes over time. Scale ranging from 5-30 where a higher score indicates a higher impact of COPD."}, {"measure"=>"Tilburg Frailty Indicator (TFI)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"Assessing multidimensional frailty among community-dwelling older people. Scale ranges from 0-15, with a score ranging from 0 to 8 for physical frailty, 0 to 4 for psychological frailty and 0 to 4 for social frailty. Higher scores refer to greater frailty, as older persons with a total TFI score ≥5 are considered to be frail."}, {"measure"=>"Tilburg Frailty Indicator (TFI)", "timeFrame"=>"Changes from baseline frailty at follow-up are assessed at 6 weeks", "description"=>"Assessing multidimensional frailty among community-dwelling older people. Scale ranges from 0-15, with a score ranging from 0 to 8 for physical frailty, 0 to 4 for psychological frailty and 0 to 4 for social frailty. Higher scores refer to greater frailty, as older persons with a total TFI score ≥5 are considered to be frail."}, {"measure"=>"Tilburg Frailty Indicator (TFI)", "timeFrame"=>"Changes from baseline frailty at follow-up are assessed at 6 months", "description"=>"Assessing multidimensional frailty among community-dwelling older people. Scale ranges from 0-15, with a score ranging from 0 to 8 for physical frailty, 0 to 4 for psychological frailty and 0 to 4 for social frailty. Higher scores refer to greater frailty, as older persons with a total TFI score ≥5 are considered to be frail."}, {"measure"=>"Tilburg Frailty Indicator (TFI)", "timeFrame"=>"Changes from baseline frailty at follow-up are assessed at 12 months", "description"=>"Assessing multidimensional frailty among community-dwelling older people. Scale ranges from 0-15, with a score ranging from 0 to 8 for physical frailty, 0 to 4 for psychological frailty and 0 to 4 for social frailty. Higher scores refer to greater frailty, as older persons with a total TFI score ≥5 are considered to be frail."}, {"measure"=>"Clinical Frailty Scale (CFS)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"Assessment of the overall level of fitness or frailty of an older adult. Scale ranges from 1-9 where a higher score indicates a higher degree of frailty."}, {"measure"=>"Clinical Frailty Scale (CFS)", "timeFrame"=>"Changes from baseline frailty at follow-up are assessed at 6 weeks", "description"=>"Assessment of the overall level of fitness or frailty of an older adult. Scale ranges from 1-9 where a higher score indicates a higher degree of frailty."}, {"measure"=>"Clinical Frailty Scale (CFS)", "timeFrame"=>"Changes from baseline frailty at follow-up are assessed at 6 months", "description"=>"Assessment of the overall level of fitness or frailty of an older adult. Scale ranges from 1-9 where a higher score indicates a higher degree of frailty."}, {"measure"=>"Clinical Frailty Scale (CFS)", "timeFrame"=>"Changes from baseline frailty at follow-up are assessed at 12 months", "description"=>"Assessment of the overall level of fitness or frailty of an older adult. Scale ranges from 1-9 where a higher score indicates a higher degree of frailty."}, {"measure"=>"Canadian Occupational Performance Measure (COPM)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"Qualitative outcome measure to assess a patients self-perception of performance in everyday living"}, {"measure"=>"Canadian Occupational Performance Measure (COPM)", "timeFrame"=>"Changes from baseline performance at follow-up are assessed at 6 weeks", "description"=>"Qualitative outcome measure to assess a patients self-perception of performance in everyday living"}, {"measure"=>"Canadian Occupational Performance Measure (COPM)", "timeFrame"=>"Changes from baseline performance at follow-up are assessed at 6 months", "description"=>"Qualitative outcome measure to assess a patients self-perception of performance in everyday living"}, {"measure"=>"Canadian Occupational Performance Measure (COPM)", "timeFrame"=>"Changes from baseline performance at follow-up are assessed at 12 months", "description"=>"Qualitative outcome measure to assess a patients self-perception of performance in everyday living"}, {"measure"=>"Six Minutes Walk Test (6MWT)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"A sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity."}, {"measure"=>"Six Minutes Walk Test (6MWT)", "timeFrame"=>"Changes from baseline mobility at follow-up are assessed at 6 weeks", "description"=>"a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity."}, {"measure"=>"Six Minutes Walk Test (6MWT)", "timeFrame"=>"Changes from baseline mobility at follow-up are assessed at 6 months", "description"=>"a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity."}, {"measure"=>"Six Minutes Walk Test (6MWT)", "timeFrame"=>"Changes from baseline and at follow-up are assessed at 12 months", "description"=>"a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity."}, {"measure"=>"Short Physical Performance Battery (SPPB)", "timeFrame"=>"Baseline measurement at initation of intervention", "description"=>"Measurement of balance, lower extremity strength, and functional capacity in older adults (\\>65 years of age). The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility."}, {"measure"=>"Short Physical Performance Battery (SPPB)", "timeFrame"=>"Changes from baseline mobility at follow-ups are assessed at 6 weeks", "description"=>"Measurement of balance, lower extremity strength, and functional capacity in older adults (\\>65 years of age). The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility."}, {"measure"=>"Short Physical Performance Battery (SPPB)", "timeFrame"=>"Changes from baseline mobility at follow-up are assessed at 6 months", "description"=>"Measurement of balance, lower extremity strength, and functional capacity in older adults (\\>65 years of age). The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility."}, {"measure"=>"Short Physical Performance Battery (SPPB)", "timeFrame"=>"Changes from baseline mobility at follow-up are assessed at 12 months", "description"=>"Measurement of balance, lower extremity strength, and functional capacity in older adults (\\>65 years of age). The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility."}, {"measure"=>"Readmissions", "timeFrame"=>"Readmissions are assessed at 12 months", "description"=>"From the electronic patient journal, data on number of participants who are readmitted, and number of individual readmissions, are collected"}, {"measure"=>"Survival rates", "timeFrame"=>"Mortality is assessed at 12 months", "description"=>"From the electronic patient journal, potential deaths amongst participants are collected"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Telerehabilitation", "COPD", "Quality of Life", "Mobility Limitation"]}, "descriptionModule"=>{"briefSummary"=>"This randomised controlled trial (RCT) aims to investigate the effect of long-term, interactive home-based cycle-exercise on patients with Chronic Obstructive Pulmonary Disease (COPD) after a COPD exacerbation requiring hospitalisation. The investigators aim to investigate if patients can maintain or improve the effects of pulmonary rehabilitation in terms of walking distance, intensity of COPD symptoms, health related quality of life and Quality Adjusted Life-Years.\n\nParticipants will cycle on a pedal-exerciser in the comfort of staying in the participants' own home, whilst getting visual feedback from the 4Mvideo app. The 4Mvideo technology is a Danish designed software system, where users can cycle forward a recording of a cyclist by treading on a pedal-exerciser, thereby getting some of the experience of a real-life cycling trip at home.\n\nThe investigators will compare the clinical outcomes and daily activity levels with that of a control group consisting of COPD patients.", "detailedDescription"=>"Patients with chronic obstructive pulmonary disease (COPD) have a higher risk of experiencing disability, and even though participating in pulmonary rehabilitation (PR) are efficient for regaining strength, function and relieving symptoms, effects prove difficult to maintain. Furthermore, physical attendance to outpatient PR is challenging for COPD patients, many of whom are bound to their home, due to said disability and symptoms. Even in patients who follow through with the PR programme, adherence to exercise after is a major challenge.\n\nThe investigators hypothesise that an intervention group of COPD-patients, who will receive home-based cycle exercise will maintain or even improve effects on physical fitness from PR, in terms of walking distance, daily activity levels (DAL), exercise tolerance, disease prevention and health related quality of life (HRQoL).\n\nFurthermore, the investigators hypothesise that the participants express improved motivation in terms of adhering to exercise, when participating in home-based, interactive group cycle exercise.\n\nIt is expected to measure changes in DAL, lung function, levels of dyspnoea, exercise tolerance, walking distance, mobility, COPD symptoms, activity of daily living (ADL) related performance and HRQoL of the participants, along with assessing disease prevention. Data is compared intrapersonal and in-between groups to identify differences in outcomes at an individual level, and between intervention- and control group. Furthermore, the investigators expect to uncover identifiable in-depth insights into the values and beliefs towards exercising amongst participants.\n\n40 participants are recruited amongst COPD patients that live in Aalborg Municipality and are admitted at Aalborg University Hospital, hospitalised due to acute exacerbation of COPD. After being discharged participants are referred to rehabilitation, for most in their own home. After rehabilitation participants are randomized into either intervention group who will exercise on exercise bikes connected with tablets in their own home. The control group will receive usual care, which consists of offers of exercising in their own home according to a programme or participating in exercise at a facility center."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adults at age \\> 18 years old\n* Hospital admission with COPD exacerbation with pre-existing COPD diagnosis\n* Citizens of Aalborg Municipality\n* Able to provide informed consent\n* Accepting of referral to rehabilitation\n\nExclusion Criteria:\n\n* Terminal illness\n* Unstable heart disease, i.e., ischemic heart disease, cardiac rhythm disorders\n* Other conditions preventing participating in cycle exercise, e.g., amputation, regimens or earlier or upcoming surgeries preventing seated position, blindness\n* Inability to understand basic Danish oral and written information or giving informed consent."}, "identificationModule"=>{"nctId"=>"NCT06235502", "acronym"=>"COPDtoParis", "briefTitle"=>"Long-term Home-based Exercise for Patients With COPD: the COPDtoParis Project", "organization"=>{"class"=>"OTHER", "fullName"=>"Aalborg University Hospital"}, "officialTitle"=>"A Randomised Controlled Trial on the Effects of Long-term Home-based Exercise for Patients With Chronic Obstructive Pulmonary Disease With Recent Exacerbation: the COPDtoParis Project", "orgStudyIdInfo"=>{"id"=>"COPDtoParis"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Home-based, longterm cycle-exercise", "description"=>"One year home-based cycle exercise on a exercise bike connected to a video app from where participants can cycle push videos forward when cycling.", "interventionNames"=>["Other: Home-based cycle-exercise for COPD patients"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Standard of Care", "description"=>"Standard of Care; exercise at fitness center, home-based exercise according to programme, self-initiated exercise", "interventionNames"=>["Other: Standard of Care"]}], "interventions"=>[{"name"=>"Home-based cycle-exercise for COPD patients", "type"=>"OTHER", "description"=>"Patients will cycle in their own home using a pedal exerciser connected to the 4M-video app", "armGroupLabels"=>["Home-based, longterm cycle-exercise"]}, {"name"=>"Standard of Care", "type"=>"OTHER", "description"=>"Exercise at Fitness Center, home based exercise according to a programme", "armGroupLabels"=>["Standard of Care"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"9000", "city"=>"Aalborg", "status"=>"RECRUITING", "country"=>"Denmark", "contacts"=>[{"name"=>"Anna L Stoustrup, MSc", "role"=>"CONTACT", "email"=>"a.stoustrup@rn.dk", "phone"=>"+4520866747"}, {"name"=>"Ulla M Weinreich, PhD, MD", "role"=>"CONTACT", "email"=>"ulw@rn.dk", "phone"=>"30687526"}], "facility"=>"Aalborg University Hospital", "geoPoint"=>{"lat"=>57.048, "lon"=>9.9187}}], "centralContacts"=>[{"name"=>"Anna L Stoustrup, MSc", "role"=>"CONTACT", "email"=>"a.stoustrup@rn.dk", "phone"=>"+45 52505879"}, {"name"=>"Ulla M Weinreich, PhD", "role"=>"CONTACT", "email"=>"ulw@rn.dk", "phone"=>"+45 30687526"}], "overallOfficials"=>[{"name"=>"Anna L Stoustrup, MSc", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"a.stoustrup@rn.dk"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"01/09/2025", "ipdSharing"=>"YES", "description"=>"Data are accessible through enquiry to principal investigator"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Aalborg University Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Karen Elise Jensen Foundation", "class"=>"OTHER"}, {"name"=>"Simon Fougners Hartmann Family Foundation", "class"=>"UNKNOWN"}, {"name"=>"4Mvideo", "class"=>"UNKNOWN"}, {"name"=>"SENS Innovation Aps", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"PhD Fellow", "investigatorFullName"=>"Anna Lei Stoustrup", "investigatorAffiliation"=>"Aalborg University Hospital"}}}}
