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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028807

Enrollment

266

Registered

2022-04-13

Start date

2022-06-13

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L20.8 L20.9 L28.0

Interventions

Group 1: Intervention group: Use of the "Nia Health" app in addition to standard care for atopic dermatitis. 3 study visits (t0 baseline

t1 6 weeks after baseline

t2 12 weeks after baseline) Per study visit: Collection of disease-specific symptoms (Eczema Area and Severity Index, SCORing Atopic Dermatitis

Patient-Oriented Eczema Measure

Investigator Global Assessment

Patient Global Assessment

Numerical Rating Scales Itching) and disease-specific quality of life (Dermatological Quality of Life Index) Group 2: Control group: Exclusive use of standard care for atopic dermatitis. 3 study visit

Numerical Rating Scales Itching) and disease-specific quality of life (Dermatological Quality of Life Index)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactPhilipp Globig

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

philipp.globig@charite.de+49 30 450518409

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026