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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06325241
• Other study ID #: 20200048-01H
• Status: Active, not recruiting
• Start date: December 12, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Frailty
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• No intervention
There is no intervention. This is an observational study.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital, General Campus	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Health Related Quality of Life	measured by the validated short version of St. Georges Respiratory Questionnaire (not a scale).	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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