ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of a Record-based Frailty Assessment According to the Multidimensional Prognostic Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03794674
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment
Frail Elderly Syndrome Other: No intervention.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Validation of a Record-based Frailty Assessment According to the Multidimensional Prognostic Index
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Group/Cohort Intervention/treatment
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.
No intervention, since this is a validation study




Primary Outcome Measures :
  1. Sumscore [ Time Frame: 1 day ]
    The relative difference between the two measurements' sumscores calculated as an Intraclass Correlation Coefficient (ICC)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794674


Contacts
Contact: Troels Hansen, MD 004530498935 trohas@rm.dk

Locations
Denmark
Aarhus University Recruiting
Aarhus, Denmark
Contact: Helene Nørrelund       hwn@clin.au.dk   
Sub-Investigator: Merete Gregersen         
Principal Investigator: Troels Hansen         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Troels Hansen, MD Aarhus University Hospital and Aarhus University
  Study Documents (Full-Text)

Documents provided by University of Aarhus:

Publications:
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.

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03794674     History of Changes
Other Study ID Numbers: MPIRECVALID
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Multidimensional Prognostic Index
Frailty
Geriatric
Elderly
Aged
+75
Comprehensive Geriatric Assessment