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

NCT00457301 | Completed Results DMC

• 1 other identifier: IHE-188
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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 patients, will: 1) improve patient-clinician communication;2) affect patient management; 3) improve patients' HRQL.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Fibrosis; Pulmonary Hypertension; Cystic Fibrosis

Keywords

Lung transplantation, health-related quality of life.

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

  Baseline and end of study (6 months)

Study Arms (1)

Control

Behavioral: HUI score card

Interventions

HUI score card BEHAVIORAL

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

Also known as: Health Utilities Index Score Card

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead
• Institute of Health Economics, Canada: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Hypertension, Pulmonary; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Interstitial; Fibrosis; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Maria Jose Santana
• Organization: Lung transplant program, University of Alberta Hospital

msantana@ualberta.ca

780-441-1661

Study Officials

• David H Feeny, PhD

  Professor Economics, University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: July 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2008
• Last Updated: April 1, 2020
• Results First Posted: September 22, 2009

Record last verified: 2020-03

Locations

CA (1)