Old and Very Old PeopleICFNCT03384732
Development of an ICF Core Set for Geriatric Patients in Primary Care
An observational study of Old and Very Old People and Independent Living, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old and Very Old People, Independent Living, Functioning
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jun 2017to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling people aged 75 years and older.
Who may be able to join
- 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
- community-dwelling people aged 75 years and older
- General practitioners, geriatricians and caregivers with at least two years of professional experience in ambulatory care.
Who cannot join
- 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:
- people with dementia
- people living in nursing homes
- people in palliative care
- Expert survey:
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Erlangen, Institute of General Practice
Erlangen, 91054
About this study
Official title: 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.
Read the 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.
- Conditions
- Old and Very Old People, Independent Living, Functioning
- Keywords
- community-dwelling elderly, ICF, core set development, geriatric, functioning, health, ageing
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 04/2018-09/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start30 Jun 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Old and Very Old PeopleStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, University of Erlangen-Nürnberg
- Responsible party
- Principal investigator, johanna tomandl, University of Erlangen-Nürnberg Medical School
- Investigators
- Thomas Kühlein, Prof. Dr., Study chair, Universitätsklinikum Erlangen, Institute of General Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384732
- Sponsor's protocol ID
- 01GY1605
- Acronym
- ICF
- Status last verified
- May 2019
- First submitted
- 12 Dec 2017
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24686893Tomandl 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.
PubMed 33597130Book 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.
PubMed 33234626Tomandl 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.
PubMed 30082366
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Core Set of the International Classification of Functioning, Disability and Health (ICF) for Geriatric Patients in Primary Care
- ClinicalTrials.gov ID
- NCT03384732
- Acronym / sponsor ID
- ICF / 01GY1605
- Conditions
- Old and Very Old People, Independent Living, Functioning
- Keywords
- community-dwelling elderly, ICF, core set development, geriatric, functioning, health, ageing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, University of Erlangen-Nürnberg
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling people aged 75 years and older.
Key inclusion criteria (6 listed)
- 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
- community-dwelling people aged 75 years and older
Key exclusion criteria (8 listed)
- studies which are solely based on one certain disease
- studies which are solely based on one ethnic group
- studies with hospitalized participants
- people with dementia
- people living in nursing homes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Background: PubMed 24686893Selb 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.
- Derived from this study: PubMed 33597130Tomandl 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.
- Derived from this study: PubMed 33234626Book 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.
- Derived from this study: PubMed 30082366Tomandl 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.
Related trials for Old and Very Old People
Not yet recruiting
Neuromuscular Electrical Stimulation in Critically Ill Patients Aged 80 and Over
Intensive Care Units (ICUs), Muscle Atrophy or Weakness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kühlein, Prof. Dr. study chair
Universitätsklinikum Erlangen, Institute of General Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Old and Very Old People and Independent Living, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Most common health issues of community-dwelling elderly reported in scientific literature (systematic literature review) (time frame: 07/2017-10/2018). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384732, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.