The Q in the QALY: exploring new methods

Completed

Conditions: Tinnitus
Anxiety or depressive complaints
atherosclerose and venous insufficiency
tinnitus
10002861
10003216

Registration Number: NL-OMON38213

Lead Sponsor: KEMTA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 184

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Quality of Life (measured with a Visual Analogue Scale, EuroQol, Experience<br /><br>Sampling method, Day Reconstruction Method, en Time Trade-Off)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2. Life satisfaction measured with the Satisfaction with Life Scale<br /><br>3. Subject characteristics and demographics<br /><br>4. Respondent burden for each method<br /><br>5. Severity of anxiety and depression is measured with the Hospital Anxiety and<br /><br>Depression Rating Scale (HADS).<br /><br>6. Optimism is measured with the Life Orientation Test (LOT-r).</p><br>