The Q in the Quality Adjusted Life Years (QALY): Exploring New Methods

NCT01085409 | Completed

• 1 other identifier: 80-82500-98-9207
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 2

Brief Summary

Aim: The aim of this proposal is to investigate the potential use and value of experienced utility, as measured by the Experience Sampling Method and the Day Reconstruction Method, in the economic evaluation of health care. Methods: Three samples of 46 patients with different conditions one sample of 46 healthy controls will be included in the study. The Experience Sampling Method (ESM) and the Day Reconstruction Method (DRM) will be adapted and subsequently used to measure experienced utility. Decision utilities will be elicited by traditional preference based methods. Expected results: The expected results of this study are threefold. First, unified versions of the ESM and DRM for use in the economic evaluation of health care will be developed and applied. Second, a rich dataset will allow us to investigate the differences between the results of experienced utilities derived from these methods, with the traditional preference based measures. Third, the normative implications of the use of QALYs based on either decision utilities, experienced utilities, or a combination of the two, for health care resource allocation decisions, will be examined. Keywords: experienced utility, decision utility, subjective well-being, experience sampling method, day reconstruction method

Conditions

Healthy

Keywords

experienced utility; decision utility; subjective well-being; experience sampling method; day reconstruction method; Quality of life

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  The primary outcome measure of this study is quality of life as measured with a Visual Analogue Scale (VAS), the EuroQol, the Experience Sampling Method, the Day Reconstruction Method and the Time trade-off.

  During 1 week

Secondary Outcomes (1)

• Life satisfaction

  2 times

Study Arms (4)

Tinnitus

Patients with tinnitus

Artery disease

Subjects with mobility constraints as a results of severe artery disease which in some cases led to leg amputation.

Anxiety

Subjects with anxiety complaints

Controls

Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Maastricht University Medical Hospital or Adelante centre of expertise in rehabilitation and audiology. Healthy controls will be recruited by advertisement in local newspapers and flyers.

You may qualify if:

• Diagnose on one of the diseases under investigation
• years or older

You may not qualify if:

• not being able to read in Dutch
• not able to handle the ESM device because of impaired motor skills

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Adelante, Centre of Expertise in Rehabilitation and Audiology: collaborator

Study Sites (2)

Adelante

Hoensbroek, Limburg, 6430AB, Netherlands

Location

Maastricht University Medical Hospital

Maastricht, Limburg, 6227 AZ, Netherlands

Location

Study Officials

• Iris Maes, MSc

  Maastricht Universitair Medical Centre

  PRINCIPAL INVESTIGATOR

• Manuela Joore, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

NL (2)