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

NCT03384732 | Completed

• 1 other identifier: 01GY1605
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Old and Very Old People; Independent Living; Functioning

Keywords

community-dwelling elderly; ICF; core set development; geriatric; functioning; health; ageing

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling people aged 75 years and older.

You may qualify if:

• 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

You may not qualify if:

• 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:
• community-dwelling people aged 75 years and older
• people with dementia
• people living in nursing homes
• people in palliative care
• Expert survey:
• General practitioners, geriatricians and caregivers with at least two years of professional experience in ambulatory care.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• German Federal Ministry of Education and Research: collaborator
• University of Erlangen-Nürnberg: collaborator

Study Sites (1)

Universitätsklinikum Erlangen, Institute of General Practice

Erlangen, 91054, Germany

Location

Related Publications (4)

• Selb M, Escorpizo R, Kostanjsek N, Stucki G, Ustun 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.

  PMID: 24686893 BACKGROUND

• Tomandl J, Heinmuller S, Selb M, Graessel E, Freiberger E, Kuhlein T, Hueber S, Book S, Gotthardt S. Laying the foundation for a Core Set of the International Classification of Functioning, Disability and Health for community-dwelling older adults in primary care: relevant categories of their functioning from the research perspective, a scoping review. BMJ Open. 2021 Feb 17;11(2):e037333. doi: 10.1136/bmjopen-2020-037333.

  PMID: 33597130 DERIVED

• Book S, Ulbrecht G, Tomandl J, Kuehlein T, Gotthardt S, Freiberger E, Graessel E. Laying the foundation for an International Classification of Functioning, Disability and Health Core Set for community-dwelling elderly adults in primary care: the clinical perspective identified in a cross-sectional study. BMJ Open. 2020 Nov 23;10(11):e038434. doi: 10.1136/bmjopen-2020-038434.

  PMID: 33234626 DERIVED

• Tomandl J, Book S, Gotthardt S, Heinmueller S, Graessel E, Freiberger E, Kuehlein T, Hueber S, Hoyer S. Laying the foundation for a core set of the International Classification of Functioning, Disability and Health for community-dwelling adults aged 75 years and above in general practice: a study protocol. BMJ Open. 2018 Aug 5;8(8):e024274. doi: 10.1136/bmjopen-2018-024274.

  PMID: 30082366 DERIVED

Study Officials

• Thomas Kühlein, Prof. Dr.

  Universitätsklinikum Erlangen, Institute of General Practice

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 27, 2017
• Study Start: June 30, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

DE (1)