NCT03871920

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

August 15, 2017

Last Update Submit

March 9, 2019

Conditions

Keywords

Physiotherapyoutcomestherapy quality

Outcome Measures

Primary Outcomes (3)

  • Test Retest reliability of SPEQ

    Intra-Class Correlation coefficient (using a two way random effects model)

    up to 30 weeks

  • Accuracy of the SPEQ

    analysis of accuracy of SPEQ to detect patients who changed in transition question with ROC analysis

    up to 30 weeks

  • Criterion Validity

    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)

    up to 30 weeks

Secondary Outcomes (4)

  • Inner consistancy

    up to 30 weeks

  • Construct validity of the SPEQ

    up to 30 weeks

  • Responsiveness of the SPEQ

    up to 30 weeks

  • Validity of the SPEQ as assessed using Spearman correlations with scores of other previously validated measures

    up to 30 weeks

Other Outcomes (3)

  • Smallest sum of the proportions of misclassification

    up to 30 weeks

  • Distribution based Minimal Important Difference

    up to 30 weeks

  • Anchor based Minimal Important Difference

    up to 30 weeks

Study Arms (1)

intervention

any kind of condition treated by physiotherapists, physical therapy treatment is chosen by treating physiotherapist

Other: physical therapy treatment

Interventions

any treatment chosen by treating physiotherapist

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Persons older than 18 years, that are in physical therapy treatment.
  • Persons must be able to read and understand German.

You may not qualify if:

  • Grave cognitive changes
  • Bedridden patients
  • Grave comorbidities that may interfere with the treatment with physical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Nico van der Maas

    Institut für Physiotherapieforschung gmbh, Biel, Switzerland

    PRINCIPAL INVESTIGATOR
  • Martin Verra, PHD

    Institute of physiotherapy, Insel university hospital, Bern, Switzerland

    PRINCIPAL INVESTIGATOR
  • Roger Hilfiger, MSc.

    HES-SO Valais/Wallis, Leukerbad, Switzerland

    PRINCIPAL INVESTIGATOR
  • Angela Balsimann Schwarz, MSc.

    Bern university of applied sciences, Health professions

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nico van der Maas

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 15, 2017

First Posted

March 12, 2019

Study Start

June 1, 2019

Primary Completion

June 1, 2019

Study Completion

October 1, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share