Efficacy of adjunctive use of the Nia Health app on disease-specific quality of life in patients with atopic dermatitis: a multicenter randomized controlled trial

Not Applicable

Recruiting

Conditions: L20.8
L20.9
Lichen simplex chronicus
L28.0
Other atopic dermatitis
Atopic dermatitis, unspecified

Registration Number: DRKS00028807

Lead Sponsor: Klinik für Dermatologie, Venerologie und Allergologie der Charité - Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 266

Inclusion Criteria

1.) Confirmed diagnosis ICD-10 L20.8, L20.9, L28.0, regardless of severity
2.) = 18 years
3.) moderate to severe influence of atopic dermatitis on disease-related quality of life (DLQI = 6)
4.) Mobile device available
5.) Consent to participate in the study

Exclusion Criteria

1.) Nia Health App already used
2.) concomitant use of another atopic dermatitis app
3.) Insufficient knowledge of German
4.) Insufficient reading and writing skills
5.) Insufficient ability to consent to study
6.) Severe diseases (e.g. autoimmune diseases)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in disease-related quality of life compared to baseline, measured with the Dermatological Quality of Life Index (DLQI), after 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.) Change in disease severity compared to baseline, measured with the Eczema Area and Severity Index (EASI) after 6 and 12 weeks.<br>2.) Change in disease severity compared to baseline, measured with the SCORing Atopic Dermatitis (SCORAD) after 6 and 12 weeks.<br>3.) Change in disease severity compared to baseline as measured by the Investigator Global Assessment (IGA) after 6 and 12 weeks.<br>4.) Change in disease-related symptoms compared to baseline, measured with the Patient Global Assessment (PGA) after 6 and 12 weeks.<br>5.) Change in disease-related symptoms compared to baseline, measured with the Patient Oriented Eczema Measure (POEM) after 6 and 12 weeks.<br>6.) Change in disease-related pruritus symptoms compared to baseline as measured by the Numeric Rating Scale (NRS) at 6 and 12 weeks.<br>7.) Compliance assessment in the intervention group: user-friendliness, measured indirectly via the number and duration of logins, continuously over the 12 weeks.