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

Active, not recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06325241
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-12
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory Health Related Quality of Life	12 months	measured by the validated short version of St. Georges Respiratory Questionnaire (not a scale).

Secondary Outcome Measures

Name	Time	Method
Burden of symptoms - Dyspnea	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.
Psycho-social well being - Depression	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.
Burden of symptoms - COPD Assessment	12 months	measured with the COPD Assessment Test where 0 means no symptoms and 5 means severe symptoms of COPD.
Psycho-social well being - Anxiety	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.

Trial Locations

Locations (1)

The Ottawa Hospital, General Campus; 🇨🇦 Ottawa, Ontario, Canada