The aim of this proposal is to investigate the potential use and value of experienced utility, as measured by the ESM and the DRM, in the economic evaluation of health care.Research question:1. What are the differences between the utilities measured…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
Tinnitus
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Quality of Life (measured with a Visual Analogue Scale, EuroQol, Experience
Sampling method, Day Reconstruction Method, en Time Trade-Off)
Secondary outcome
2. Life satisfaction measured with the Satisfaction with Life Scale
3. Subject characteristics and demographics
4. Respondent burden for each method
5. Severity of anxiety and depression is measured with the Hospital Anxiety and
Depression Rating Scale (HADS).
6. Optimism is measured with the Life Orientation Test (LOT-r).
Background summary
Over the last decades the use of utilities in economic evaluations of health
care programmes has received some serious critique. Criticism was mainly aimed
on the fact that utilities are based on preferences for hypothetical situations
(decision utilities), and not on real experiences. It was suggested to use
utilities based on experienced well-being (experienced utility) should be used
in stead of utilties based on preferences in economic evaluation of health care
programmes. New state-of-the-art methods to assess experienced utilityare the
Experience Sampling Method (ESM) and the Day Reconstruction Method (DRM).
However, empirical evidence regarding the use of these methods to assess
experienced utility as outcome in the economic evaluation of health care is
virtually lacking.
Study objective
The aim of this proposal is to investigate the potential use and value of
experienced utility, as measured by the ESM and the DRM, in the economic
evaluation of health care.
Research question:
1. What are the 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?
Study design
Observational study
Study burden and risks
Subjects are invited to the health care setting of their choice (MUMC+ or
Adelante). The first visit will take half a day, the second visit will take two
hours maximum. All subjects receive an electronic device that will signal them
10 times a day (random) for 6 days, to answer questions on their feelings,
thoughts and activities at that moment. Subjects are able to turn of the sound
of the device at moments this is desirable. A lot of studies using the ESM have
been done at the Maastricht University. Drop-out rates are comparable to other
studies. These findings indicate that subjects do not experience this as
burdening.
There are no risks linked to this study.
Postbus 5800
6202 AZ Maastricht
NL
Postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
With regard to patients with tinnitus:
- Referral to an audiological centre because of tinnitus complaints;
- 18 years or older;With regard to the patients with anxiety complaints
- Anxiety or depressive complaints,
- A score >8 points at the anxiety or depression scale on the HADS or a total score of >12
- 18 years or older;With regard to the patients with atherosclerose or venous insufficiency:
- Diagnoses of venous insufficiency or atherosclerose;
- In case of a leg amputation: finished clinical rehabilitation at Adelante, centre of expertise in rehabilitation and audiology
- 18 years or older.;Healthy population:
- 18 years or older.
Exclusion criteria
With regard to patients with tinnitus:
- Organic cause of tinnitus
- Not able to read in Dutch;
- Not able to handle the ESM device because of impaired motor skills.;With regard to the patients with anxiety or depressive complaints:
- Not able to read in Dutch;
- Not able to handle the ESM device because of impaired motor skills.;With regard to the patients that underwent a leg amputation:
- Not able to read in Dutch;
- Not able to handle the ESM device because of impaired motor skills.;With regard to the healthy population :
- Not able to read in Dutch;
- Not able to handle the ESM device because of impaired motor skills.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01085409 |
| CCMO | NL31422.068.10 |