Does Augmented Reality Improve Disease Understanding and Outcomes in Axial Spondyloarthritis? A multicenter, investigator-blinded, randomized, controlled, parallel-group interventional phase IV trial to evaluate the effect of Augmented Reality–enhanced patient education on illness perception, adherence, and disease activity in axial spondyloarthritis

Does Augmented Reality Improve Disease Understanding and Outcomes in Axial Spondyloarthritis? A multicenter, investigator-blinded, randomized, controlled, parallel-group interventional phase IV trial to evaluate the effect of Augmented Reality–enhanced patient education on illness perception, adherence, and disease activity in axial spondyloarthritis - ARISE-AS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040870

Enrollment

120

Registered

2026-07-07

Start date

2026-08-24

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

M45

Interventions

Group 1: Intervention group (Augmented Reality): After screening, informed consent and baseline assessments, participants are randomized 1:1. Participants allocated to this study arm receive a single

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of axial spondyloarthritis according to current classification criteria Active disease (ASDAS-CRP >2.0) Current treatment with self-administered medication (e.g. oral or subcutaneous) or planned initiation or switch to such treatment based on clinical indication At least one and no more than five previous DMARD therapies Self-rated disease-related knowledge of moderately informed or worse Ability to complete study questionnaires independently Sufficient German language skills Written informed consent

Exclusion criteria

Exclusion criteria: Current or planned intravenous antirheumatic therapy Other inflammatory rheumatic systemic diseases likely to affect study outcomes Severe cognitive impairment or relevant psychiatric disorders Neurological disorders or contraindications to Augmented Reality applications (e.g. photosensitive epilepsy) Acute severe comorbidities Participation in another interventional clinical trial Unwillingness or inability to comply with the study protocol

Design outcomes

Primary

Measure	Time frame
Change in illness perception measured using the Brief Illness Perception Questionnaire (BIPQ). The primary outcome is the between-group difference in change of the total BIPQ score from baseline (Visit 1) to 4 weeks after the intervention (Visit 3). Data are collected using the standardized BIPQ questionnaire.	—

Secondary

Measure	Time frame
Secondary outcomes include: Change in illness perception (BIPQ) 1 hour after the intervention Change in beliefs about medicines (BMQ) at 4, 12 and 24 weeks Change in treatment adherence (CQR-5) at 4, 12 and 24 weeks Change in disease activity (ASDAS-CRP) at 12 and 24 weeks Change in patient-reported disease activity (BASDAI) at 12 and 24 weeks Change in functional impairment (BASFI) at 12 and 24 weeks Change in pain intensity (NRS 0–10) throughout the study Change in patient and physician global disease activity (NRS 0–10) at 12 and 24 weeks Participant evaluation of the educational intervention immediately after the intervention. Data are collected using standardized questionnaires, clinical assessments, and routine laboratory measurements (CRP, ESR).	—

Measure

Time frame

Secondary outcomes include: Change in illness perception (BIPQ) 1 hour after the intervention Change in beliefs about medicines (BMQ) at 4, 12 and 24 weeks Change in treatment adherence (CQR-5) at 4, 12 and 24 weeks Change in disease activity (ASDAS-CRP) at 12 and 24 weeks Change in patient-reported disease activity (BASDAI) at 12 and 24 weeks Change in functional impairment (BASFI) at 12 and 24 weeks Change in pain intensity (NRS 0–10) throughout the study Change in patient and physician global disease activity (NRS 0–10) at 12 and 24 weeks Participant evaluation of the educational intervention immediately after the intervention. Data are collected using standardized questionnaires, clinical assessments, and routine laboratory measurements (CRP, ESR).

—

Countries

Germany

Contacts

Public ContactPhilipp Klemm

Justus-Liebig-Universität Gießen, Campus Kerckhoff, Abteilung für Rheumatologie

p.klemm@kerckhoff-klinik.de060329960

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026