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

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: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Health Related Quality of Life	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	measured with the COPD Assessment Test where 0 means no symptoms and 5 means severe symptoms of COPD.	12 months
Burden of symptoms - Dyspnea	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	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	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

• Sponsor: Ottawa Hospital Research Institute

Study record dates

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: Frailty; Care expectations
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Frailty
• 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