ICF Core Set for Primary Care Physiotherapy

Musculoskeletal Diseases Clinical Trial

Official title:

Development of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06168721
• Other study ID #: CEIm 2987
• Status: Active, not recruiting
• Start date: January 22, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University of Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Primary care physiotherapy services provide community-based care for musculoskeletal conditions. These conditions are often associated with disability and impact on patients' quality of life. The International Classification of Functioning, Disability and Health (ICF) is the global framework for describing disability. ICF Core Sets are ICF-based tools that facilitate the clinical use of this classification. The development of these tools follows a scientific process that combines the perspectives of researchers, patients, professionals, and the care setting. Our research team has conducted preliminary studies and identified candidate ICF categories with good potential for inclusion in a preliminary version of an ICF Core Set for the treatment of musculoskeletal conditions in community physical therapy settings. The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of this ICF Core Set.

Description:

Primary care physiotherapy services provide community-based care for musculoskeletal conditions. These conditions are often associated with disability and impact on patients' quality of life. The International Classification of Functioning, Disability and Health (ICF) is the global framework for describing disability. ICF Core Sets are ICF-based tools that facilitate the clinical use of this classification. Some ICF Core Sets are designed to describe the functioning of patients with musculoskeletal problems.

These Core Sets are focused on the acute phase, typical of emergency care, and the post-acute phase, intended for multidisciplinary teams in rehabilitation centers. However, no ICF core set exists for the final stages of these conditions, when the patient has been reintegrated into the community. The development of ICF Core Sets follows a scientific process that integrates the perspectives of researchers, patients, professionals, and the care setting. Therefore, preparatory studies have been carried out, taking as a reference the physiotherapy services in primary care, where most of these conditions are treated.

These preparatory studies have made it possible to draw up a list of ICF categories that are candidates for being part of an ICF core set specific to these services. To confirm the relevance of these categories, a cross-sectional observational study will be developed by recruiting a group of experts. The experts will carry out two rounds of the survey according to the Delphi method. To be part of this group, sufficient expertise in the field of primary care physiotherapy will be required. The categories that reach consensus among these experts will be proposed in the development of a tailored ICF Core Set for primary care physiotherapy services.

The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of an ICF Core Set for the management of musculoskeletal conditions in a primary care physiotherapy clinical setting. The availability of this tool would allow guiding physical therapy assessments, selecting optimal outcome measures, implementing person-centered care, and systematically recording clinical data.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 67 Years

Eligibility

Inclusion Criteria:

• Be physiotherapists working in a primary care setting for the duration of the study.

• Have more than 5 years of experience in this clinical setting.

• Evidence of completion of at least 200 hours of additional training, teaching, research, and/or administrative activities related to the clinical setting.

Exclusion Criteria:

• Work in a rehabilitation center or hospital context.

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

Other:
• Expert survey
The expert group will participate in a two-round survey using the Delphi method. The first round aims to assess the relevance of the proposed ICF categories and to identify missing concepts. The second round will aim to confirm the appropriateness of including the selected categories in the ICF core set. Each round will last 3 weeks and the experts will be provided with feedback on the results obtained.

Locations

Country	Name	City	State
Spain	Ólvega Primary Health Center	Ólvega	Soria

Sponsors (2)

Lead Sponsor	Collaborator
University of Valladolid	Sanidad de Castilla y León

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. 2023 Sep 5:1-8. doi: 10.1080/09638288.2023.2251392. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic data of the sample	Data set for the characterization of the expert panel (age, gender, education level, work experience and information on the current job)	2024-01/2024-06
Primary	Relevance of candidate ICF categories (First Delphi Round)	The relevance of the categories will be measured on a 5-point Likert scale: "not relevant" (score 1), "hardly relevant" (score 2), "somewhat relevant" (score 3), "relevant" (score 4) and "very relevant" (score 5).	2024-01/2024-06
Primary	Judgment on the clinical utility of the selected ICF categories (Second Delphi Round)	Dichotomous question (yes/no) on the appropriateness of including or excluding the most relevant ICF categories in the ICF core set.	2024-01/2024-06
Secondary	Missing functioning concepts (First Delphi Round)	Open-ended question related to ICF	2024-01/2024-06