NCT03794674

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2019

Completed
Last Updated

October 8, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

December 21, 2018

Last Update Submit

October 7, 2019

Conditions

Keywords

Multidimensional Prognostic IndexFrailtyGeriatricElderlyAged+75Comprehensive Geriatric Assessment

Outcome Measures

Primary Outcomes (1)

  • Sumscore

    The relative difference between the two measurements' sumscores calculated as an Intraclass Correlation Coefficient (ICC)

    1 day

Study Arms (1)

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.

Other: No intervention.

Interventions

No intervention, since this is a validation study

MPI test group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Acutely admitted to one of the two medical departments listed below
  • Aged 75 years or older
  • Living within the municipality of Aarhus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, Denmark

Location

Related Publications (9)

  • 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.

    PMID: 27039014BACKGROUND
  • 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.

    PMID: 23395245BACKGROUND
  • 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.

    PMID: 25209253BACKGROUND
  • 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.

    PMID: 18173367BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26812520BACKGROUND
  • Hopkins WG. Measures of reliability in sports medicine and science. Sports Med. 2000 Jul;30(1):1-15. doi: 10.2165/00007256-200030010-00001.

    PMID: 10907753BACKGROUND
  • 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.

    PMID: 16980142BACKGROUND
  • 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.

    PMID: 17161752BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Troels Hansen, MD

    Aarhus University Hospital and Aarhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2018

First Posted

January 7, 2019

Study Start

December 4, 2018

Primary Completion

February 21, 2019

Study Completion

February 22, 2019

Last Updated

October 8, 2019

Record last verified: 2018-12

Locations