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

May 17, 2019 updated by: johanna tomandl, University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen, Institute of General Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community-dwelling people aged 75 years and older.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Most common health issues of community-dwelling elderly reported in scientific literature (systematic literature review)
Time Frame: 07/2017-10/2018
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)
Time Frame: 06/2017-01/2018
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)
Time Frame: 06/2018-04/2019
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)
Time Frame: 04/2018-09/2018
The primary outcome will be a core set containing relevant ICF categories from the clinical perspective.
04/2018-09/2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

German Federal Ministry of Education and Research
University of Erlangen-Nürnberg

Investigators

  • Study Chair: Thomas Kühlein, Prof. Dr., Universitätsklinikum Erlangen, Institute of General Practice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2017

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01GY1605

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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