NCT04900480

Brief Summary

The aim of this pilot study is to evaluate the effect of publicly subsidized physiotherapy for all patients receiving general treatment in physiotherapy clinics with an official provider number. This study will evaluate effects on physical and mental health, number of consultations in physiotherapy; number of contacts with general practitioner; referrals to diagnostic imaging; number of contacts with specialists within rheumatology, neurology and orthopedics and patient satisfaction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,427

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

February 12, 2020

Last Update Submit

March 22, 2022

Conditions

Musculoskeletal Diseases

Keywords

PhysiotherapyPublic subsidyDirect access

Outcome Measures

Primary Outcomes (2)

  • Change from baseline physical functioning at 6 months

    Physical functioning will be measured by a validated Danish Short Form 12 instrument. The questionnaire consists of six items weighted, summed and transformed to provide physical health score. The score of 50 represents the median score of a reference population. 10 points equals 1 standard deviation. Higher score equal better physical health.

    Six months

  • Consultations in general practice

    Number of consultations in general practice

    Six months after intervention period

Secondary Outcomes (16)

  • Consultations with specialists within rheumatology

    Six months after intervention period

  • Consultations with specialists within neurology

    Six months after intervention period

  • Consultations with specialists within orthopedics

    Six months after intervention period

  • Referrals to diagnostic imaging

    Six months after intervention period

  • Cancer diagnoses

    Five years after intervention period

  • +11 more secondary outcomes

Study Arms (2)

Public subsidy to physiotherapy continue as usual

NO INTERVENTION

This control arm consists of all physiotherapy clinics with registered provider numbers in two municipalities, where the access and public subsidy to physiotherapy continue as usual.

Direct access to publicly subsidized physiotherapy

EXPERIMENTAL

This intervention arm consists of all physiotherapy clinics with registered provider numbers in two municipalities, introducing temporary exemption on the legal required general practitioner referral for public subsidy for treatment in general physiotherapy.

Other: Direct access to publicly subsidized physiotherapy

Interventions

Direct access to publicly subsidized physiotherapyOTHER

This pilot project introduces temporary exemption on the legal required GP referral for public subsidy for treatment in general physiotherapy.

Direct access to publicly subsidized physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Begin treatment in general physiotherapy within the four municipalities included

You may not qualify if:

  • Pregnancy
  • Have a GP referral to home treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Research and Prevention

Copenhagen, 2000, Denmark

Location

Related Publications (1)

  • Dahlerup J, Toft U, Schiotz ML, Grew J, Thrysoe R, Ottosen J, Jakobsen LM. Protocol for a cluster-randomized non-inferiority trial of the effect of direct access to publicly subsidized physiotherapy for adults with musculoskeletal pain. Contemp Clin Trials. 2022 Feb;113:106648. doi: 10.1016/j.cct.2021.106648. Epub 2021 Dec 10.

    PMID: 34896641DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Ulla Toft, ph.d.

    Center for Clinical Research and Prevention

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department, Lecturer Ph.D, MSc Human Nutrition

Study Record Dates

First Submitted

February 12, 2020

First Posted

May 25, 2021

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)