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

This study has been completed.
Sponsor:
Collaborator:
Adelante, Centre of Expertise in Rehabilitation and Audiology
Information provided by (Responsible Party):
Iris Maes, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01085409
First received: March 10, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Q in the QALY: Exploring New Methods

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: During 1 week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Life satisfaction [ Time Frame: 2 times ] [ Designated as safety issue: No ]
    Life satisfaction as mesured with te Satisfaction with Life Scale.


Enrollment: 139
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

This study explores new methodology regarding the measurement of health state utilities. A new pharmaceutical is nowadays only reimbursed if there is evidence of cost-effectiveness. This can be determined by different types of economic evaluations, of which cost-utility analysis (CUA) is preferred in most guidelines. In CUA the health outcome of a technology is measured in quality adjusted life years (QALY). Utilities to calculate QALYs should be based on decisions under uncertainty (decision utilities). However, the health care literature describes several problems that lead to bias in the measurement of decision utilities. These biases lead to an inaccurate estimation of the value of a health state and can therefore cause policy makers to allocate resources inefficiently. To solve some of these problems, it was suggested to determine experiences associated with different health states by measuring well-being moment-to-moment (experienced utility) by the Experience Sampling Method or the Day Reconstruction Method.

Differences between the utilities measured using traditional preference based measures (decision utility), and using the new state-of-art methods ESM and DRM (experienced utility) in a range of populations with differing conditions and severity of health state will be investigated. Since somatic, psychosomatic and psychological conditions are likely to differ in the way they experience and affect well-being, we will involve patient groups from each category in this study as well as healthy controls.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not being able to read in Dutch
  • not able to handle the ESM device because of impaired motor skills
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085409

Locations
Netherlands
Adelante
Hoensbroek, Limburg, Netherlands, 6430AB
Maastricht University Medical Hospital
Maastricht, Limburg, Netherlands, 6227 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Adelante, Centre of Expertise in Rehabilitation and Audiology
Investigators
Principal Investigator: Iris Maes, MSc Maastricht Universitair Medical Centre
Principal Investigator: Manuela Joore, PhD Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Iris Maes, MSc, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01085409     History of Changes
Other Study ID Numbers: 80-82500-98-9207
Study First Received: March 10, 2010
Last Updated: May 6, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
experienced utility
decision utility
subjective well-being
experience sampling method
day reconstruction method
Quality of life

ClinicalTrials.gov processed this record on July 22, 2014