- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139162
Development of Clinical Indicators From the Swiss RAI-HC (IndiRAI)
April 11, 2023 updated by: Catherine Ludwig, School of Health Sciences Geneva
Development of Frailty and Complexity Indices From Data Collected With Resident Assessment Instrument - Home Care Adapted for Switzerland
The project aims at deriving frailty (FI) and complexity (CI) indices from data collected with the Resident Instrument Assessment - Home Care adapted for Switzerland (RAI-HC).
Data were collected in 2015 by trained nurses in clinical routine with the primary purposes of health state assessment and individual home care planning.
The study consists in a retrospective secondary analysis of health data from the Minimal Data Set (MDS), used to derive frailty and complexity indices according to published definitions and guidelines for index derivation.
The analysis further aims at estimating the predictive power of these indices on undesirable health outcomes (falls, hospitalizations and deaths).
The goal is to provide home care institutions and nurses valid algorithms to compute useful clinical indicators without additional assessment that the one routinely done with the RAI-HC.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10000
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Adult applicants for home care services provided by imad (Geneva, Switzerland) who received a first RAI-HC assessment in 2015 for routine care planning purposes
Description
Inclusion Criteria:
- Men and women aged 18 or older who were assessed in 2015 with the Swiss RAI-HC in clinical routine for care planning by the Geneva Institution for Home care and Assistance (imad) in Geneva, Switzerland
Exclusion Criteria:
- Men and women aged 17 or younger and/or who did not receive a full RAI-HC assessment in 2015
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty Index
Time Frame: 1 year
|
Index with a value ranging from 0 to 100, computed as the sum of health deficits recorded with the RAI-HC MDS divided by the number of deficits considered
|
1 year
|
|
Complexity Index
Time Frame: 1 year
|
Index with a value ranging from 0 to 100, computed as the sum of complexity items recorded with the RAI-HC MDS divided by the number of items considered
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls
Time Frame: 6 months on average
|
Falls recorded by means of follow-up RAI-HC assessments
|
6 months on average
|
|
Hospitalizations
Time Frame: 6 months on average
|
Hospitalizations recorded by means of follow-up RAI-HC assessments
|
6 months on average
|
|
Mortality
Time Frame: through study completion, an average of 5 year
|
Deceased (yes/no); collected through administrative records
|
through study completion, an average of 5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherine Ludwig, PhD, School of Health Sciences Geneva
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
- Hubbard RE, Peel NM, Samanta M, Gray LC, Fries BE, Mitnitski A, Rockwood K. Derivation of a frailty index from the interRAI acute care instrument. BMC Geriatr. 2015 Mar 18;15:27. doi: 10.1186/s12877-015-0026-z.
- Loeb DF, Binswanger IA, Candrian C, Bayliss EA. Primary care physician insights into a typology of the complex patient in primary care. Ann Fam Med. 2015 Sep;13(5):451-5. doi: 10.1370/afm.1840.
- Morris JN, Fries BE, Steel K, Ikegami N, Bernabei R, Carpenter GI, Gilgen R, Hirdes JP, Topinkova E. Comprehensive clinical assessment in community setting: applicability of the MDS-HC. J Am Geriatr Soc. 1997 Aug;45(8):1017-24. doi: 10.1111/j.1532-5415.1997.tb02975.x.
- Armstrong JJ, Stolee P, Hirdes JP, Poss JW. Examining three frailty conceptualizations in their ability to predict negative outcomes for home-care clients. Age Ageing. 2010 Nov;39(6):755-8. doi: 10.1093/ageing/afq121. Epub 2010 Sep 21. No abstract available.
- Ludwig C, Busnel C. Derivation of a frailty index from the resident assessment instrument - home care adapted for Switzerland: a study based on retrospective data analysis. BMC Geriatr. 2017 Sep 7;17(1):205. doi: 10.1186/s12877-017-0604-3.
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)
January 1, 2015
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
April 11, 2023
Study Registration Dates
First Submitted
April 24, 2017
First Submitted That Met QC Criteria
May 2, 2017
First Posted (Actual)
May 3, 2017
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 74217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The coded datasets supporting the findings of this study are not publicly available for they belong to imad and are not the property of the authors of the study.
The data analyzed for the study could be made available from the authors upon reasonable request and with prior agreement by imad.
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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