Chronic Obstructive Pulmonary DiseaseNCT00457301

Using Health-related Quality of Life (HRQL) in Routine Clinical Care

An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Fibrosis, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to assess the effects of using HRQL measures in the clinical care of pre- and post-lung transplant patients. The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System Mark 2(HUI2) and Mark 3 (HUI3), in routine clinical care of pre- and post-lung transplant… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis, Pulmonary Hypertension
What is being tested?: HUI score card
Type of treatment: Lifestyle or therapy programme
How many people: 213 participants
Where: 1 siteCanada
Study dates: Jul 2005to May 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

pre-lung transplant:subjects who are included on the waiting list and are being seen at the out-patient clinic
post-lung transplant subjects.

Who cannot join

younger than 18 years of age
diagnosed as being cognitively impaired
unable to complete questionnaires in English

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Alberta Hospital
Edmonton, Alberta

Other trials in Canada

About this study

Official title: An Assessment of the Effects of the Use of Measures of Health-related Quality of Life in Routine Clinical Care:an Application to Lung Transplantation.

The objective of this study is to assess the effects of using HRQL measures in the clinical care of pre- and post-lung transplant patients.

The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System Mark 2(HUI2) and Mark 3 (HUI3), in routine clinical care of pre- and post-lung transplant patients, will: 1) improve patient-clinician communication;2) affect patient management; 3) improve patients' HRQL.

Read the detailed description

Recently there has been increasing interest in the use of health-related quality of life (HRQL) measures in routine clinical practice. Traditionally, patient care has been based on laboratory results, medical history, and signs and symptoms diagnosed by clinicians. The inclusion of HRQL measures in routine practice may provide important and often otherwise missing information, revealing the impact of the disease or its treatment on the patient's physical, emotional and social well-being, and may assist in patient management. HRQL assessments may assist in changing the medical paradigm from a disease-centered approach to a patient-centered one.

Several studies in mental health and oncology discuss the application of HRQL measures in clinical practice. Taenzer et al (2000) and Detmar et al. (2002) provide evidence that using HRQL measures improves patient-clinician communication. Velikova et al (2004) detected impacts on communication and the emotional well-being of patients.

Using a framework based on these previous studies and the methods for the health technology assessment of diagnostic technologies (Guyatt et al. 1986), we will assess the effects of including HRQL assessments in the routine clinical care of patients undergoing solid organ transplantation (lung).

We expect that the routine use of HRQL measures in clinical practice will affect patient-clinician communication, patient management, and patient outcome.

Lung transplantation trades a fatal disease (end-stage pulmonary disease) for a chance at prolonged survival and improved quality of life, albeit with immunosuppression. In this context, generic preference-based measures such as HUI2 and HUI3 are preferred to specific measures, because they measure a broader range of health dimensions, including pain, ambulation and emotional issues that are expected to be relevant. Preference-based measures provide scores on the conventional 0.00 (dead) to 1.00 (perfect health) scale that allows for the integration of morbidity and mortality effects and calculation of quality adjusted life years (QALYs) and health-adjusted life expectancy (HALE).

Conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis, Pulmonary Hypertension, Cystic Fibrosis
Being tested: HUI score card
Keywords: Lung transplantation, health-related quality of life.
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis, Hypertension, Pulmonary, Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HUI score cardBehavioural
Also called Health Utilities Index Score Card
Patients completed the HUI2 and HUI3 before the encounter with the clinician, the result was graphically represented in the HUI score card. Clinicians used the HUI score card as an extra tool to help them in the management of the patients

Study groups in NCT00457301
Study group	Role	What they receive
Control		Not described Receives: Behavioral: HUI score card

What is being measured

The primary outcome is the main question the study is designed to answer.

Communication Score
Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems.
Measured: Baseline and end of study (6 months)
Management Composite
Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite.
Measured: At baseline and end of study (6 months)
EuroQol, EQ-5D.
Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute ("no problem", "some problems" and "extreme problems").Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable.
Measured: At baseline and end of study (6 months).

Secondary outcomes (1)

The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
HADS is a self-complete mental health measure. The scale consists of 14 items, seven of which assess anxiety and seven which assess depression. Each item is on a four point scale and the scores are added to give a total ranging from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores indicate more severe anxiety or depression. A cut-point of 8 or 9 indicates mild burden for the two scales; 11 or 12 indicates severe . All the patients completed HADS at baseline and at the end of the study.
Measured: Baseline and end of study (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005May 2008

First posted6 Apr 2007 (estimated)
Study startJul 2005
Primary completionApr 2007
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by University of AlbertaThe 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
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00457301
Sponsor's protocol ID: IHE-188
Status last verified: Mar 2020
First submitted: 4 Apr 2007
Last updated: 1 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Assessment of the Effects of the Use of Measures of Health-related Quality of Life in Routine Clinical Care:an Application to Lung Transplantation.
ClinicalTrials.gov ID: NCT00457301
Acronym / sponsor ID: IHE-188
Conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis, Pulmonary Hypertension, Cystic Fibrosis
Keywords: Lung transplantation, health-related quality of life.
Study type: Observational
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: University of AlbertaUniversity, hospital or other
Collaborators: Institute of Health Economics, Canada, Roche Pharma AG
Study start: Jul 2005
Primary completion: Apr 2007 (actual)
Study completion: May 2008 (actual)
First posted: 6 Apr 2007 (estimated)
Results: Posted 22 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to assess the effects of using HRQL measures in the clinical care of pre- and post-lung transplant patients.

Detailed description

We expect that the routine use of HRQL measures in clinical practice will affect patient-clinician communication, patient management, and patient outcome.

Study design

Number of arms: 1

Arm	Type	Receives
Control	–	Behavioral: HUI score card

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

pre-lung transplant:subjects who are included on the waiting list and are being seen at the out-patient clinic
post-lung transplant subjects.

Key exclusion criteria (3 listed)

younger than 18 years of age
diagnosed as being cognitively impaired
unable to complete questionnaires in English

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
HUI score cardAlso: Health Utilities Index Score CardPatients completed the HUI2 and HUI3 before the encounter with the clinician, the result was graphically represented in the HUI score card. Clinicians used the HUI score card as an extra tool to help them in the management of the patients	Behavioural	Control

Primary outcome

Communication Score
Time frame: Baseline and end of study (6 months)
Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems.
Management Composite
Time frame: At baseline and end of study (6 months)
Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite.
EuroQol, EQ-5D.
Time frame: At baseline and end of study (6 months).
Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute ("no problem", "some problems" and "extreme problems").Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable.

1 secondary outcome

The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
Time frame: Baseline and end of study (6 months)

Results and safety

Results posted to the registry on 22 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HUI2 and HUI3 Completion Without Feedback to Clinicians.	105	82
HUI2 and HUI3 Completion and Feedback to Clinicians	108	84

Primary outcome: Communication Score

Time frame: Baseline and end of study (6 months). Mean (Standard Deviation). Unit: Mean number of issues discussed

Measure	HUI2 and HUI3 Completion Without Feedback to Clinicians. n = 105	HUI2 and HUI3 Completion and Feedback to Clinicians n = 108
baseline	1.14 (1.16)	1.50 (1.10)
End-of-study	1.36 (1.00)	1.75 (1.15)

HUI2 and HUI3 Completion Without Feedback to Clinicians. vs HUI2 and HUI3 Completion and Feedback to Clinicians: Slope: 0.28, p = 0.05, ANCOVA

Population analysed: Traditional analysis of covariance, ANCOVA was conducted to explore the difference between control and intervention groups at 6 months adjusting for baseline scores and transplant status. ITT was conducted and missing values were imputed using the LOCF.

Primary outcome: Management Composite

Time frame: At baseline and end of study (6 months). Mean (Standard Deviation). Unit: mean management composite

Measure	HUI2 and HUI3 Completion Without Feedback to Clinicians. n = 105	HUI2 and HUI3 Completion and Feedback to Clinicians n = 108
Baseline	0.70 (1.52)	1.20 (2.50)
End-of-study	2.19 (2.84)	3.27 (3.35)

HUI2 and HUI3 Completion Without Feedback to Clinicians. vs HUI2 and HUI3 Completion and Feedback to Clinicians: Slope: 0.79, p = 0.001, ANCOVA

Population analysed: Analysis was conducted using ITT, with 47 observations carried forward.

Primary outcome: EuroQol, EQ-5D.

Time frame: At baseline and end of study (6 months).. Mean (Standard Deviation). Unit: mean EQ-5D index score

Measure	HUI2 and HUI3 Completion Without Feedback to Clinicians. n = 105	HUI2 and HUI3 Completion and Feedback to Clinicians n = 108
baseline	0.76 (0.17)	0.76 (0.17)
end of study	0.75 (0.23)	0.72 (0.25)

HUI2 and HUI3 Completion Without Feedback to Clinicians. vs HUI2 and HUI3 Completion and Feedback to Clinicians: Slope: 0.01, p = 0.46, ANCOVA

Population analysed: To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error, two-sided-test and 80% power. ITT was conducted for 213 recruited patients. 47 records were imputed using LOCF.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HUI2 and HUI3 Completion Without Feedback to Clinicians.	0 of 105 (0%)	0 of 105 (0%)	Not reported
HUI2 and HUI3 Completion and Feedback to Clinicians	0 of 108 (0%)	0 of 108 (0%)	Not reported

Limitations and caveats (from the sponsor): Randomizing patients instead of clinicians lead to sensitizing effects. EQ-5D is a generic preference-based measure, a specific measure should have been used to maximize responsiveness.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

David H Feeny, PhD principal investigator

Professor Economics, University of Alberta

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 and Pulmonary Fibrosis, run by University of Alberta 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 1 Apr 2020. 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?

Yes. Results are posted in the registry (first posted 22 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Communication Score (time frame: Baseline and end of study (6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00457301.

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 1 Apr 2020.