Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 7
- Primary Endpoint
- Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code
Overview
Brief Summary
This prospective, multicenter, controlled real-world quality management study explores the acceptance and utility of two measures discussed in the context of the German Digital Act (DigiG) for the digital health application (DiGA) Axia: a 14-day trial period and an application-related outcome measurement (AbEM). Patients with axial spondyloarthritis in Axia's indication area who are eligible for prescription in routine care will receive one of two onboarding brochure versions in a 1:1 allocation: either the standard access procedure or immediate 14-day trial access until the health insurance activation code arrives. The manufacturer will analyze aggregated anonymized data to compare voucher redemption and app activation frequencies between groups and to assess acceptance and return rates of a voluntary five-item AbEM questionnaire at weeks 6 and 12. Secondary analyses will descriptively evaluate AbEM results and anonymized usage data.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willingness to use Axia.
- •Axia indication area.
- •Willingness to activate via onboarding brochure.
Exclusion Criteria
- •Absence of the inclusion criteria
Arms & Interventions
Standard procedure
Intervention: Standard procedure (Other)
Immediate app-use by a test phase
Intervention: Test-phase with immediate access (Device)
Outcomes
Primary Outcomes
Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code
Time Frame: 12 weeks
Successful app activation is defined as successful redemption of the activation code by the participant. The outcome measure is the percentage of participants with successful app activation from baseline through week 12.
Secondary Outcomes
- Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM)(6 and 12 weeks)
- Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire(6 and 12 weeks)
- Exploratory analysis of anonymized usage data.(12 weeks)
Investigators
Patrick-Pascal Strunz
PD. Dr. med.
Wuerzburg University Hospital