Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases (E-PsEYE) who receive intra-ocular anti-VEGF injections: RCT

Completed

Conditions: angstsymptomen
fear
fright (anxiety)
diabetic retinopathy
down (depression)
low spirits
retinal diseases
10027946
macular degeneration
10047060

Registration Number: NL-OMON45657

Lead Sponsor: Oogheelkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 202

Inclusion Criteria

Inclusion criteria for patients are: (A) patients should have at least mild symptoms of depression and/or anxiety (score of 5 or higher on the Patient Health Questionnaire (PHQ)-9, and/or score of 3 or higher on the Hospital Anxiety and Depression Scale * Anxiety (HADS-A)); (B) patients should be able to speak the Dutch language adequately; and (C) patients should have access to the Internet.;For the problem analysis of the implementation study, social workers who are currently working at low vision rehabilitation organisations (n*8), managers/directors from these organisations (n*2), ophthalmologists (n*4), nurses and desk assistants (n*4), managers/department heads from the Ophthalmology department of Dutch academic and general hospitals (n*3) and health insurers (n*3) will be included. The aim is to involve a diverse group of these professionals (with different backgrounds and demographic characteristics) in order to obtain the best possible picture of barriers and facilitators for the implementation of E-PsEYE.

Exclusion Criteria

Exclusion criteria for patients are: (A) patients are cognitively impaired, which is assessed by telephone with the six-item Mini Mental State Examination (score <3); (B) patients have severe depression (score of 20 or higher on the PHQ-9); (C) patients are suicidal; and (D) patients are heavy drinkers (score of 8 or higher on the Alcohol Use Disorders Identification Test questionnaire (AUDIT)).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main outcome measures are: depression (measured with the Patient Health<br /><br>Questionnaire-9), and anxiety (measured with the Hospital Anxiety and<br /><br>Depression Scale * Anxiety). Quality-adjusted life-years are determined with<br /><br>the Health Utility Index-3 and the EuroQol-5 Dimensions..</p><br>

Secondary Outcome Measures