Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-17 @ 7:59 AM
Study NCT ID:
NCT03871920
Status:
UNKNOWN
Last Update Posted:
2019-03-12
First Post:
2017-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychometric Evaluation of the Short Patient Evaluation Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-09', 'studyFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2019-03-09', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Smallest sum of the proportions of misclassification', 'timeFrame': 'up to 30 weeks', 'description': 'By defining a cut-off value at the smallest sum of the proportions of misclassification, the investigators will define Minimal Important Difference'}, {'measure': 'Distribution based Minimal Important Difference', 'timeFrame': 'up to 30 weeks', 'description': 'MID is defined for all items and the sum of item scores as 0.5 Standard Deviation, Standard Error Measurement and Minimal Detectable Change at the 95% confidence interval'}, {'measure': 'Anchor based Minimal Important Difference', 'timeFrame': 'up to 30 weeks', 'description': 'MID is defined for item 2, 3 and the sum of items scores as the average change between T1 and T2 for the subset of patients with a minimal change as determined by the transition question.'}], 'primaryOutcomes': [{'measure': 'Test Retest reliability of SPEQ', 'timeFrame': 'up to 30 weeks', 'description': 'Intra-Class Correlation coefficient (using a two way random effects model)'}, {'measure': 'Accuracy of the SPEQ', 'timeFrame': 'up to 30 weeks', 'description': 'analysis of accuracy of SPEQ to detect patients who changed in transition question with ROC analysis'}, {'measure': 'Criterion Validity', 'timeFrame': 'up to 30 weeks', 'description': 'The validity will be assessed using hypothesis testing of correlations (between SPEQ and existing previously validated measures). The SPEQ has a sufficient criterion validity, if these correlations are at least moderate (rho\\>0.5)'}], 'secondaryOutcomes': [{'measure': 'Inner consistancy', 'timeFrame': 'up to 30 weeks', 'description': 'The inner consistency will be calculated with ordinal alpha.'}, {'measure': 'Construct validity of the SPEQ', 'timeFrame': 'up to 30 weeks', 'description': 'Categorial principle component analysis of SPEQ will be performed to asses the construct validity of the SPEQ.'}, {'measure': 'Responsiveness of the SPEQ', 'timeFrame': 'up to 30 weeks', 'description': 'Sensitivity to change will be evaluated using Effect Size, Standardized Mean, Modified standardized Mean and Relative efficiency.'}, {'measure': 'Validity of the SPEQ as assessed using Spearman correlations with scores of other previously validated measures', 'timeFrame': 'up to 30 weeks', 'description': 'The validity of the SPEQ was determined by calculating Spearman correlations between SPEQ and scores of previously validated measures (EQ-5D-5L, SF-12 and SPQ). Scores \\>0.6 were considered indicative of high validity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physiotherapy', 'outcomes', 'therapy quality'], 'conditions': ['Patient Reported Outcomes']}, 'descriptionModule': {'briefSummary': 'It is important for physiotherapy in general and for the individual physio-therapist to demonstrate the result of the interventions in physiotherapy. The new short (4 items) generic questionnaire Short Patient Evaluation Questionnaire SPEQ was especially developed for use in private practices to answer the main questions for evaluation of treatment. This research project aims at evaluating the reliability, validity and responsiveness of the SPEQ and at providing an estimate for Minimal Important Difference MID that may be used as threshold for clinical relevant changes.', 'detailedDescription': 'In this study the investigators evaluate the reliability, validity and responsiveness of the SPEQ and providing an estimate for Minimal Important Difference MID. They will use a longitudinal multicenter design with an adequate sample size of n=250 for validity and n=80 for reliability evaluation. Private practices and the Department of Physiotherapy of the Inselspital, Bern University Hospital, will participate in the study.\n\nReliability will be evaluated in a test-retest setting and with ordinal alpha. The SPEQ will be compared to the Euroqual-5-Dimensions-5-Levels (EQ-5D-5L), Short Form 12 (SF-12) and Patient Satisfaction Questionnaire (PSQ) to evaluate the validity. Responsiveness will be evaluated using a criterion validity approach and hypothesis testing of the correlation between SPEQ and the other questionnaires. In addition, the investigators will calculate ES, Standardized Response Mean (SRM), Modified SRM (MSRM) and relative efficiency between SPEQ and the criterions. For MID estimates, they use a combined anchor and distribution based approach. The anchors for the items are provided by the T0- and T1-questionnaire.\n\nPatients will be recruited by the treating physiotherapists and provide written informed consent. At baseline, they will complete the T0-questionnaire, SF-12 and EQ-5D-5L. At the end of treatment or after 6 month of treatment for persons in long term treatment, the patients will fill out SPEQ, the T1-questionnaire, SF-12, EQ-5D-5L, and the PSQ. Two to seven days after the second test series, a subset of patients(n=80) will be asked to answer the SPEQ questions again by telephone.\n\nDescriptive statistics will describe missing data, distribution of data over scale levels, frequency, floor and ceiling effects. Scaling will be tested by comparing pearson and spearman correlations and effect size (ES) for ordinal data and for metric data. Independence will be evaluated with the Mann-Whitney U test. The assumptions for building a sum of score will be evaluated comparing and assessing the spearman correlations and a categorical principle component analysis of the matrix of the 4 items of the SPEQ.\n\nThe reliability will be evaluated. Correlations between the SPEQ and the criterions EQ-5D-5L, SF-12 and PSQ will demonstrate validity.\n\nResponsiveness will be evaluated analyzing the correlations between SPEQ and criterion and hypothesis testing of change of scores (Cosmin). Furthermore we will calculate the several traditional statistics; Effect Size, Standardized Response Mean, Modified Standardized Response Mean and relative efficiency between SPEQ and the criterion; distribution based Minimal Important Change estimates will be calculated with 0.5 Standard Deviation, Standard Error Measurement and Minimal Detectable Change at the 95% confidence interval; the mean between T0 and T1 values are anchor-based MID estimates. The range of anchor and distribution based MIC estimates will be analysed by Receiver Operating Characteristics curves. The result of the analysis provides an estimate that will be compared to the MID estimate of the criterion validity approach. Finally the threshold for clinical relevant change for the items and the sum of scores of the SPEQ will be determined.\n\nThe investigators expect the SPEQ to be a reliable, valid and responsive patient rated outcome assessment that can be used in the evaluation of the results of physiotherapy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of the regular patient in full age in physical therapy treatment without a grave other health problems, that may interfere with the result of the treatment with physiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Persons older than 18 years, that are in physical therapy treatment.\n* Persons must be able to read and understand German.\n\nExclusion criteria\n\n* Grave cognitive changes\n* Bedridden patients\n* Grave comorbidities that may interfere with the treatment with physical therapy'}, 'identificationModule': {'nctId': 'NCT03871920', 'briefTitle': 'Psychometric Evaluation of the Short Patient Evaluation Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Institut fuer Physiotherapieforschung'}, 'officialTitle': 'A Prospective Multi Center Prospective Cross-sectional and Longitudinal Study to Evaluate the Psychometric Properties of the Short Patient Evaluation Questionnaire', 'orgStudyIdInfo': {'id': 'SPEQ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intervention', 'description': 'any kind of condition treated by physiotherapists, physical therapy treatment is chosen by treating physiotherapist', 'interventionNames': ['Other: physical therapy treatment']}], 'interventions': [{'name': 'physical therapy treatment', 'type': 'OTHER', 'description': 'any treatment chosen by treating physiotherapist', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nico van der Maas', 'role': 'CONTACT', 'email': 'ipforschung@sunrise.ch', 'phone': '+41764373695'}], 'overallOfficials': [{'name': 'Nico van der Maas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut für Physiotherapieforschung gmbh, Biel, Switzerland'}, {'name': 'Martin Verra, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of physiotherapy, Insel university hospital, Bern, Switzerland'}, {'name': 'Roger Hilfiger, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HES-SO Valais/Wallis, Leukerbad, Switzerland'}, {'name': 'Angela Balsimann Schwarz, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern university of applied sciences, Health professions'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanco van der Maas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': 'HES-SO Valais-Wallis', 'class': 'OTHER'}, {'name': 'University of Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Nanco van der Maas', 'investigatorAffiliation': 'Institut fuer Physiotherapieforschung'}}}}