- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03794674
Validation of a Record-based Frailty Assessment According to the Multidimensional Prognostic Index
October 7, 2019 updated by: University of Aarhus
Background Various phenotype and cumulative frailty assessment tools have been developed and compared in research.
For use in an in-hospital setting, a cumulative and graded frailty assessment method is preferred in order to identify subgroups of patients at risk of adverse events during discharge and transition to primary care.
Comprehensive Geriatric Assessment (CGA) is the gold standard to assess frailty.
Most medical wards have limited access to specialized geriatric team support capable of performing CGA.
Thus in these wards there is a need for a CGA based instrument to identify the frail patients and to quantify the level of frailty.
The Multidimensional Prognostic Index (MPI) is based on CGA and is a comprehensive cumulative deficit frailty assessment tool validated in a Danish geriatric department.
MPI is fully applicable in the everyday clinical work and supplies useful information to clinicians.
It can predict readmission and death, and it is well-suited to assess the degree of frailty.
Enabling identification of patients at risk of adverse events facilitates targeting of the interventions in order to improve patient outcomes.
The MPI is a bedside assessment.
However, in observational record-based research the patient is not accessible for the researcher.
To assess and identify hospitalized frail patients retrospectively for clinical research, a valid record-based frailty assessment method is needed.
The aim of this study is to compare the accuracy of a record-based MPI assessment with a bedside performed MPI assessment in order to use the record-based MPI when access to bedside MPI is impossible.
Study Overview
Study Type
Observational
Enrollment (Actual)
92
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
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Aarhus, Denmark
- Aarhus University
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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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study group comprises medical patients acutely admitted to the Department of Cardiology and the Department of Infectious Diseases, Aarhus University Hospital.
Description
Inclusion Criteria:
- Acutely admitted to one of the two medical departments listed below
- Aged 75 years or older
- Living within the municipality of Aarhus
Exclusion Criteria:
- Included in any other kind of follow-up schemes
- Already included in this study
- Declared terminally ill or undergoing palliative care at admission
- Admitted from one specific temporary nursing home with geriatric medical assistance (Vikærgården)
- Discharge or transfer to another department, including hospice
- The patient does not want to participate in the MPI-screening process
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: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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MPI test group
50 eligible patients.
Frailty level independently assessed by two reviewers based on the medical records and assessed by one research assistant based on bedside testing.
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No intervention, since this is a validation study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sumscore
Time Frame: 1 day
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The relative difference between the two measurements' sumscores calculated as an Intraclass Correlation Coefficient (ICC)
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1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Troels Hansen, MD, Aarhus University Hospital and Aarhus University
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
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Erratum In: Lancet. 2013 Oct 19;382(9901):1328.
- Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
- Dent E, Kowal P, Hoogendijk EO. Frailty measurement in research and clinical practice: A review. Eur J Intern Med. 2016 Jun;31:3-10. doi: 10.1016/j.ejim.2016.03.007. Epub 2016 Mar 31.
- Volpato S, Bazzano S, Fontana A, Ferrucci L, Pilotto A; MPI-TriVeneto Study Group. Multidimensional Prognostic Index predicts mortality and length of stay during hospitalization in the older patients: a multicenter prospective study. J Gerontol A Biol Sci Med Sci. 2015 Mar;70(3):325-31. doi: 10.1093/gerona/glu167. Epub 2014 Sep 9.
- Pilotto A, Ferrucci L, Franceschi M, D'Ambrosio LP, Scarcelli C, Cascavilla L, Paris F, Placentino G, Seripa D, Dallapiccola B, Leandro G. Development and validation of a multidimensional prognostic index for one-year mortality from comprehensive geriatric assessment in hospitalized older patients. Rejuvenation Res. 2008 Feb;11(1):151-61. doi: 10.1089/rej.2007.0569.
- Gregersen M, Hansen TK, Jørgensen BB, Damsgaard EM. Validation of a modified Multidimensional Prognostic Index obtained at discharge in older Danish geriatric patients to predict acute readmission and mortality. 2018 Unpublished data.
- Warnier RM, van Rossum E, van Velthuijsen E, Mulder WJ, Schols JM, Kempen GI. Validity, Reliability and Feasibility of Tools to Identify Frail Older Patients in Inpatient Hospital Care: A Systematic Review. J Nutr Health Aging. 2016 Feb;20(2):218-30. doi: 10.1007/s12603-015-0567-z.
- Hopkins WG. Measures of reliability in sports medicine and science. Sports Med. 2000 Jul;30(1):1-15. doi: 10.2165/00007256-200030010-00001.
- de Vet HC, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. J Clin Epidemiol. 2006 Oct;59(10):1033-9. doi: 10.1016/j.jclinepi.2005.10.015. Epub 2006 Aug 10.
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)
December 4, 2018
Primary Completion (Actual)
February 21, 2019
Study Completion (Actual)
February 22, 2019
Study Registration Dates
First Submitted
December 21, 2018
First Submitted That Met QC Criteria
January 2, 2019
First Posted (Actual)
January 7, 2019
Study Record Updates
Last Update Posted (Actual)
October 8, 2019
Last Update Submitted That Met QC Criteria
October 7, 2019
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPIRECVALID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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