Chronic Obstructive Pulmonary DiseaseNCT06325241
Validating the Use of Frailty Measurements to Predict Care & Quality of Life
An observational study of Chronic Obstructive Pulmonary Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Outpatients of The Ottawa Hospital Respirology clinic
- Chronic Obstructive Pulmonary Disease diagnosis confirmed by pulmonary function testing.
- English or French speaking
Who cannot join
- patients with a known diagnosis of severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- No intervention
- Keywords
- Frailty, Care expectations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Also called there are no other names.
There is no intervention. This is an observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Health Related Quality of Life
measured by the validated short version of St. Georges Respiratory Questionnaire (not a scale).
Measured: 12 months
Secondary outcomes (4)
Burden of symptoms - COPD Assessment
measured with the COPD Assessment Test where 0 means no symptoms and 5 means severe symptoms of COPD.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start12 Dec 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunita Mulpuru, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325241
- Sponsor's protocol ID
- 20200048-01H
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06325241
- Acronym / sponsor ID
- 20200048-01H
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Frailty, Care expectations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Outpatients of The Ottawa Hospital Respirology clinic
- Chronic Obstructive Pulmonary Disease diagnosis confirmed by pulmonary function testing.
- English or French speaking
Key exclusion criteria (1 listed)
- patients with a known diagnosis of severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAlso: there are no other names.There is no intervention. This is an observational study. | Other | – |
Primary outcome
Respiratory Health Related Quality of Life
Time frame: 12 months
measured by the validated short version of St. Georges Respiratory Questionnaire (not a scale).
4 secondary outcomes
Burden of symptoms - COPD Assessment
Time frame: 12 months
Burden of symptoms - Dyspnea
Time frame: 12 months
Psycho-social well being - Anxiety
Time frame: 12 months
Psycho-social well being - Depression
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Health Related Quality of Life (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.