Development of an ICF Core Set for Geriatric Patients in Primary Care

Independent Living Clinical Trial

— ICF  

Official title:

Development of a Core Set of the International Classification of Functioning, Disability and Health (ICF) for Geriatric Patients in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384732
• Other study ID #: 01GY1605
• Status: Completed
• Start date: June 30, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The sum of medical interventions can do more harm than good. Supporting patients' resources instead of combating disease might effectively help reducing "too much medicine". A first step to approach this goal would be to have a classification tool that captures the essential features of a meaningful human life, namely body functions, activities, and participation. The International Classification of Functioning, Disability and Health (ICF) is the perfect framework to distinguish between necessary and unnecessary medical interventions by offering descriptions of outcomes of medical and non-medical interventions. However, though adequate and comprehensive in theory, it is impracticable in a primary care setting. Therefore, a core set of the ICF for the old and very old in primary care is needed. Four preparatory studies according to the international development guideline will be carried out: a systematic literature review to capture the research perspective, a qualitative study to assess the patients' perspective, an experts' survey and an empirical multicenter study to detect the clinical perspective.

Description:

The systematic literature review captures the perspective of researchers on functioning of community dwelling people aged 75 years and older. Different literature databases will be searched combining search terms referring to community dwelling elderly and to functioning. Two investigators will independently screen the abstracts and titles for eligibility. In reviewing the full articles, the underlying concepts that are contained in the measures and in the article text will be identified, and then linked to the ICF categories using established linking rules. A frequency analysis will be conducted on the linked categories. The ICF categories that are identified in at least 5% of all publications will be included in the list of candidate categories.

The qualitative study aims to identify which aspects of functioning, environmental and personal factors are most important to community dwelling people aged 75 years and older. Participants will be provided with a camera for one week to take pictures of activities they are no longer able to perform or activities they still perform well. On the basis of these pictures, individual interviews and focus groups will be conducted. Meaningful concepts will be identified and linked to the ICF categories.

The expert survey aims to gather opinions of experts on aspects of functioning and environmental factors that are relevant for community dwelling people aged 75 years and older. Meaningful concepts will be identified and linked to the ICF categories.

The empirical multicenter study aims to identify the most common problems experienced by community-dwelling people aged 75 and older using clinical assessments. A health professional will conduct semi-structured interviews based on the extended ICF checklist. This is a selection of 125 categories that are considered to be most important for clinical practice. This list is extended by other categories thought to be sensitive to functioning in old age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

Systematic review:

Inclusion criteria:

• conducted in the EU, EFTA countries, Australia, New Zealand, USA, Canada

• published in a peer-review journal

• published since 2007

• RCT, controlled clinical trial, cross-sectional study, observational study, qualitative study

Exclusion criteria:

• studies which are solely based on one certain disease

• studies which are solely based on one ethnic group

• studies with hospitalized participants

Qualitative study/empirical multicenter study:

Inclusion criteria:

• community-dwelling people aged 75 years and older

Exclusion criteria:

• people with dementia

• people living in nursing homes

• people in palliative care

Expert survey:

Inclusion criteria

• General practitioners, geriatricians and caregivers with at least two years of professional experience in ambulatory care.

Related Conditions & MeSH terms

• Functioning
• Independent Living
• Old and Very Old People

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen, Institute of General Practice	Erlangen

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	German Federal Ministry of Education and Research, University of Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Selb M, Escorpizo R, Kostanjsek N, Stucki G, Üstün B, Cieza A. A guide on how to develop an International Classification of Functioning, Disability and Health Core Set. Eur J Phys Rehabil Med. 2015 Feb;51(1):105-17. Epub 2014 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Most common health issues of community-dwelling elderly reported in scientific literature (systematic literature review)	The primary outcome will be a core set containing relevant ICF categories from the researchers' perspective.	07/2017-10/2018
Primary	ADL abilities and disabilities of community-dwelling elderly reported by community-dwelling elderly in semi-structured interviews and focus groups (qualitative study)	The primary outcome will be a core set containing relevant ICF categories from the patients' perspective.	06/2017-01/2018
Primary	ADL abilities and disabilities of community-dwelling elderly reported by experts in an online survey (expert survey)	The primary outcome will be a core set containing relevant ICF categories from the experts' perspective.	06/2018-04/2019
Primary	Most common health issues of community-dwelling elderly assessed by the extended ICF checklist (empirical multicenter study)	The primary outcome will be a core set containing relevant ICF categories from the clinical perspective.	04/2018-09/2018