Applicability of the ICF in Primary Care Physiotherapy Units in the Health Service of Castille and Leon (Spain)

NCT04135976 | Completed

• 1 other identifier: CEIC 2231
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

The primary care physiotherapy units of the Spanish health service in Castille and Leon (SACYL) are responsible for providing physiotherapy treatments to the general population. Being part of the primary health care system, the actions of these units are aimed at the treatment of common conditions that do not involve severity, frequently musculoskeletal disorders. The work of physiotherapists is closely related to the functionality of patients and, in this sense, the World Health Organization (WHO) has proposed the International Classification of Functioning, Disability and Health (ICF) as a conceptual framework to characterize the functional status of individuals. The use of ICF in the clinical setting is not sufficiently widespread due to the the difficulties that the use of such an exhaustive classification implies in practice. In an attempt to address this problem, the WHO has encouraged the development of reduced versions aimed at responding to specific conditions or care contexts. The idea behind the development of core sets is that it is possible to select a number of categories so as to capture the essence of a given clinical process, allowing an agile use of the ICF. However, in order to put these core sets into practice, it is necessary to check that the selected categories are valid from the perspective of the participants in the clinical processes. The purpose of this research project is to determine whether the musculoskeletal core sets of the ICF are applicable in SACYL primary care physiotherapy units. This implies knowing if the categories already selected in these sets are representative of the health aspects considered as most relevant in the clinical context of physiotherapy in primary care. To achieve this, four studies will be conducted to capture the perspective of patients, physiotherapists, researchers and clinical practice. This information will be translated into the language of the ICF to obtain comparable categories with those present in the core sets. In this way, this research project will make possible to validate or adapt the core sets of the ICF for musculoskeletal conditions, in a specific clinical context of physiotherapy in primary care.

Conditions

Musculoskeletal Diseases or Conditions

Keywords

physiotherapy; primary health care; ICF; core set validation; musculoskeletal conditions

Outcome Measures

Primary Outcomes (4)

• Most important issues related to functional status, disability and health in the treatment of musculoskeletal conditions in primary care, according to the ICF, reported in the scientific literature.

  The measurement instruments used by primary care researchers will be broken down into units of meaning and converted into ICF categories using the conversion rules proposed by Cieza et al. The primary result is the achievement of the categories considered most relevant by primary care researchers.

  2022/05 - 2022/09

• Most important issues related to functional status, disability and health in general population treated in physical therapy units for musculoskeletal conditions reported by physiotherapists in an online survey (expert survey).

  The primary outcome will be a set of ICF categories that will be representative of the physiotherapists' perspective. The Delphy study will gather information from physioterapists working in a primary care set. This information will be converted into ICF categories using the conversion rules.

  2020/06 - 2021/03

• Most important issues related to functional status, disability and health in general population treated in physical therapy units for musculoskeletal conditions reported by these patients in focus groups (qualitative study).

  The primary outcome will be a set of ICF categories that will be representative of the patients' perspective. The focus groups will provide information about the point of view of the patients treated in primary care physioterapy units. Using the conversion rules, the information will be translated into ICF categories.

  2022/05 - 2022/12

• Most important issues related to functional status, disability and health in patients treated in physical therapy units for musculoskeletal conditions, assessed by the comprehensive musculoskeletal ICF core set (empirical multicenter study).

  Physiotherapists will evaluate a group of patients using the comprehensive ICF core set for post-acute musculoskeletal conditions. These patients will be asked to assess the relevance of the categories included in the ICF core set, according to their health problem. A 0-100 mm visual analog scale (VAS) will be used to rate each ICF category (a score of 5 or higher would validate the ICF category). The primary outcome will be the percentage of validated categories included in the ICF core set.

  2022/05 - 2023/03

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

General population over 18 years of age that has been treated in a physiotherapy unit in primary care during the last year, or is going to be treated in these units during the development of this research project.

You may qualify if:

• Primary care studies over adult general population in developed Western countries
• Published in a peer-review journal
• Published since 2009
• Type of publication: random controlled trials, controlled clinical trial, cross-sectional study, observational study and qualitative study

You may not qualify if:

• Studies based solely in specific health problems
• Studies not conducted over general population (some kind of selection based on ethnicity, sex, social class, etc. have been made).
• Studies with hospitalized participants
• Studies published in a language other than English or Spanish
• Expert survey:
• Physiotherapists with at least two years of professional experience in primary health care.
• Qualitative study
• Treated in a physiotherapy unit during the past year.
• Over 18 years old
• Inability to concentrate for 30 minutes.
• Insufficient knowledge of the Spanish language.
• Empirical multicenter study:
• Patients over 18 years referred to a primary care physiotherapy unit
• Inability to concentrate for 30 minutes.
• Insufficient knowledge of the Spanish language.

Sponsors & Collaborators

• University of Valladolid: lead
• Sanidad de Castilla y León: collaborator

Study Sites (1)

Ólvega Primary Health Center

Ólvega, Soria, 42110, Spain

Location

Related Publications (4)

• Hernandez-Lazaro H, Mingo-Gomez MT, Ceballos-Laita L, Medrano-de-la-Fuente R, Jimenez-Del Barrio S. Validation of the international classification of functioning, disability, and health (ICF) core sets for musculoskeletal conditions in a primary health care setting from physiotherapists' perspective using the Delphi method. Disabil Rehabil. 2023 Jul;45(15):2458-2468. doi: 10.1080/09638288.2022.2096128. Epub 2022 Jul 13.

  PMID: 35830343 RESULT

• Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Lahuerta-Martin S, Hernando-Garijo I, Medrano-de-la-Fuente R, Ceballos-Laita L. Researcher's Perspective on Musculoskeletal Conditions in Primary Care Physiotherapy Units through the International Classification of Functioning, Disability, and Health (ICF): A Scoping Review. Biomedicines. 2023 Jan 20;11(2):290. doi: 10.3390/biomedicines11020290.

  PMID: 36830831 RESULT

• Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Rodriguez-Fernandez AI, Areso-Boveda PB, Ceballos-Laita L. Validation of the International Classification of Functioning, Disability, and Health (ICF) core set for post-acute musculoskeletal conditions in a primary care physiotherapy setting from the perspective of patients using focus groups. Disabil Rehabil. 2024 Aug;46(16):3594-3601. doi: 10.1080/09638288.2023.2251392. Epub 2023 Sep 5.

  PMID: 37667886 RESULT

• Hernandez-Lazaro H, Jimenez-Del Barrio S, Ceballos-Laita L, Lahuerta-Martin S, Medrano-de-la-Fuente R, Hernando-Garijo I, Mingo-Gomez MT. Multicentre cross-sectional study assessing content validity of the International Classification of Functioning, disability and health core set for post-acute musculoskeletal conditions in primary care physiotherapy services. J Rehabil Med. 2023 Nov 16;55:jrm11950. doi: 10.2340/jrm.v55.11950.

  PMID: 37974517 RESULT

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• María Teresa Mingo Gómez

  University of Valladolid

  STUDY DIRECTOR

• Héctor Hernández Lázaro

  University of Valladolid

  PRINCIPAL INVESTIGATOR

• Sandra Jiménez del Barrio

  University of Valladolid

  STUDY DIRECTOR

• Luis Ceballos Laita

  University of Valladolid

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 23, 2019
• Study Start: June 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: June 30, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)