Validating the Use of Frailty Measurements to Predict Care & Quality of Life

April 23, 2024 updated by: Sunita Mulpuru, Ottawa Hospital Research Institute

Validating the Use of Frailty Measurements to Predict Care Expectations and Deteriorations in Quality of Life Among People With COPD: A Prospective Cohort Study

The aim of this research program is to validate frailty measurements as a risk stratification tool to predict deteriorations in patient-reported outcomes, to gain a better understanding of patient preferences for care within varying degrees of frailty, and to assess differences in frailty measurement between patients and their clinicians.

This work will provide a foundation in the development of customized interventions for people with COPD and varying degrees of frailty, with the goal of improving quality of life and optimizing health system service delivery for patients and their care givers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

123

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1J 0J2
        • The Ottawa Hospital, General Campus

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

French or English speaking outpatients of the Ottawa Hospital Respirology clinic who are diagnoses with Chronic Obstructive Pulmonary Disease, which is confirmed by pulmonary function testing who are able to speak on the phone for at least 10 minutes.

Description

Inclusion Criteria:

  • Outpatients of The Ottawa Hospital Respirology clinic
  • Chronic Obstructive Pulmonary Disease diagnosis confirmed by pulmonary function testing.
  • English or French speaking

Exclusion Criteria:

  • patients with a known diagnosis of severe cognitive impairment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Health Related Quality of Life
Time Frame: 12 months
measured by the validated short version of St. Georges Respiratory Questionnaire (not a scale).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden of symptoms - COPD Assessment
Time Frame: 12 months
measured with the COPD Assessment Test where 0 means no symptoms and 5 means severe symptoms of COPD.
12 months
Burden of symptoms - Dyspnea
Time Frame: 12 months
measured with the modified Medical Research Council scales. Measured on a scale of 0-4 where 0 means not breathless and 4 is too breathless.
12 months
Psycho-social well being - Anxiety
Time Frame: 12 months
measured with the validated Generalized Anxiety Disorder-7. GAD-7 results vary between 0 and 21, the higher the score, the more anxiety.
12 months
Psycho-social well being - Depression
Time Frame: 12 months
measured with the Patient Health Questionnaire-8 scales. PHQ8 results vary between 0 and 24, where the higher the number, more severe is the persons' level of depression.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

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 12, 2022

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200048-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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