Responsiveness and Minimal Clinical Important Difference of the Multiple Sclerosis Questionnaire for Physiotherapists

NCT02346279 | Completed

• 1 other identifier: Responsivität und MCID MSQPT
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this survey is the evaluation of the responsiveness and the estimation of the MCID of the German and French Multiple Sclerosis Questionnaire for Physiotherapists, a self-rating Patient Reported Outcome questionnaire. This multicenter project uses a combined anchor and distribution based approach with multiple anchors to provide a range of MCID estimates or a single MCID for the reliable and valid Items, Activity and Participation group and the Total Score of the MSQPT, which should to be used as guidelines in daily practice.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Rehabilitation; Questionnaire; Patient-Reported Outcome; Responsiveness; Minimal Important Clinical Difference

Outcome Measures

Primary Outcomes (1)

• Multiple Sclerosis Questionnaire for Physical Therapists

  Items 'Taking a Shower', 'Getting in and out of a car', 'Walking distance' and Walking Time', Activity Group, Participation Group, Total Sum of Items

  20 minutes

Secondary Outcomes (6)

• 6 Meter Timed Walking Test

  3 to 20 seconds

• Nine Hole Peg Test

  up to 5 minutes

• Berg Balance Scale

  20 minutes

• Hamburg Quality of Life Questionnaire in Multiple Sclerosis

  20 minutes

• Expanded Disability Status Scale

  5 minutes

Study Arms (1)

Persons in physical therapy treatment

Questionnaires (MSQPT, HAQUAMS, Transition Questionnaire for Patient and treating physiotherapist), physical tests (9HPT, 6MTWT, BBS, 6MWT), EDSS

Other: Questionnaires, EDSS, physical test

Interventions

Questionnaires, EDSS, physical test OTHER

6 Meter timed walking test, Nine Hole Peg Test, Berg balance Scale, MSQPT, HAQUAMS, Transition Questionnaire for Patients, Transition Questionnaire for Therapists, EDSS, 6 Minute Walking Test

Persons in physical therapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons suffering from Multiple Sclerosis that are in physical therapy treatment because of the multiple sclerosis and are treated in private practice or in ambulant department of hospitals in the German part of Switzerland

You may qualify if:

• Patients with a diagnosed MS, who are in physiotherapeutic treatment because of MS, older than 18 year, must be able to read the MSQPT by himself, native language German or French, EDSS score of less or equal 6.5

You may not qualify if:

• Acute episode of MS, grave cognitive changes, bedfast patient, distinct fatigue, able to perform less than 2 hours

Sponsors & Collaborators

• Institut fuer Physiotherapieforschung: lead
• Schweizer Physiotherapie Verband physioswiss: collaborator
• Schweizerische Multiple Sklerose Gesellschaft: collaborator

Related Publications (6)

• Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2(14):i-iv, 1-74. No abstract available.

  PMID: 9812244 BACKGROUND

• Gold SM, Heesen C, Schulz H, Guder U, Monch A, Gbadamosi J, Buhmann C, Schulz KH. Disease specific quality of life instruments in multiple sclerosis: validation of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS). Mult Scler. 2001 Apr;7(2):119-30. doi: 10.1177/135245850100700208.

  PMID: 11424632 BACKGROUND

• Learmonth YC, Paul L, McFadyen AK, Mattison P, Miller L. Reliability and clinical significance of mobility and balance assessments in multiple sclerosis. Int J Rehabil Res. 2012 Mar;35(1):69-74. doi: 10.1097/MRR.0b013e328350b65f.

  PMID: 22315143 BACKGROUND

• Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. doi: 10.1016/j.jclinepi.2007.03.012. Epub 2007 Aug 3.

  PMID: 18177782 BACKGROUND

• Wyrwich KW, Norquist JM, Lenderking WR, Acaster S; Industry Advisory Committee of International Society for Quality of Life Research (ISOQOL). Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res. 2013 Apr;22(3):475-83. doi: 10.1007/s11136-012-0175-x. Epub 2012 Apr 17.

  PMID: 22528240 BACKGROUND

• van der Maas NA. Patient-reported questionnaires in MS rehabilitation: responsiveness and minimal important difference of the multiple sclerosis questionnaire for physiotherapists (MSQPT). BMC Neurol. 2017 Mar 16;17(1):50. doi: 10.1186/s12883-017-0834-1.

  PMID: 28302081 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nanco van der Maas

  Institut für Physiotherapieforschung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 26, 2015
• Study Start: April 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 27, 2015

Record last verified: 2015-01