NCT06325241

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

November 10, 2023

Last Update Submit

April 23, 2024

Conditions

Keywords

FrailtyCare expectations

Outcome Measures

Primary Outcomes (1)

  • Respiratory Health Related Quality of Life

    measured by the validated short version of St. Georges Respiratory Questionnaire (not a scale).

    12 months

Secondary Outcomes (4)

  • Burden of symptoms - COPD Assessment

    12 months

  • Burden of symptoms - Dyspnea

    12 months

  • Psycho-social well being - Anxiety

    12 months

  • Psycho-social well being - Depression

    12 months

Interventions

There is no intervention. This is an observational study.

Also known as: there are no other names.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • patients with a known diagnosis of severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1J 0J2, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveFrailty

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Investigator

Study Record Dates

First Submitted

November 10, 2023

First Posted

March 22, 2024

Study Start

December 12, 2022

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations