DiGA@Ortho: Digital health applications in orthopaedics and trauma surgery from the patients' perspective - a mixed-methods study focussing on acceptance, potentials and challenges

DiGA@Ortho: Digital health applications in orthopaedics and trauma surgery from the patients' perspective - a mixed-methods study focussing on acceptance, potentials and challenges - DiGA@Ortho

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036514

Enrollment

200

Registered

2025-04-10

Start date

2024-12-15

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

M23.2 M23.3 M23.61 S83.2 S83.53 M22 M22.2 M22.4 M76.5 M79.66 S83.0

Interventions

Group 1: The study includes adult patients undergoing orthopaedic care at the university clinics of the Brandenburg Medical School Theodor Fontane with a knee joint disease who are eligible for DiGA u

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Prescription of a DiGA, undergoing orthopaedic treatment, German-speaking, a signed declaration of consent is required for all participants to take part in the qualitative study, no signed declaration of consent is required to take part in the questionnaire survey. Participants consent to the survey by ticking the box at the beginning of the questionnaire.

Exclusion criteria

Exclusion criteria: No DiGA prescription, not undergoing orthopaedic treatment, underage, unable to communicate in German, discontinuation criteria in accordance with the DiGA discontinuation criteria: in the event of a deterioration in general condition such as fever, cold, flu-like infection, dizziness, drowsiness, any acute inflammation, a general feeling of illness or severe pain

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is to explore the perspective of DiGA users in detail, in particular to examine adherence and to record both qualitatively and quantitatively the potentials and challenges from the patients' perspective. Adherence and motivation: at the time of inclusion and after three weeks via telephone interview, after three and six weeks via questionnaire with TUUSQ, questions about usage behaviour, ‘Net Promotor Score’. Potentials and challenges: at the time of inclusion and after three weeks via telephone interview. Both general questions, such as: ‘What general advantages do you see in the use of DiGAs?’, and questions specifically tailored to the knee DiGAs are asked.	—

Measure

Time frame

The primary endpoint of the study is to explore the perspective of DiGA users in detail, in particular to examine adherence and to record both qualitatively and quantitatively the potentials and challenges from the patients' perspective. Adherence and motivation: at the time of inclusion and after three weeks via telephone interview, after three and six weeks via questionnaire with TUUSQ, questions about usage behaviour, ‘Net Promotor Score’. Potentials and challenges: at the time of inclusion and after three weeks via telephone interview. Both general questions, such as: ‘What general advantages do you see in the use of DiGAs?’, and questions specifically tailored to the knee DiGAs are asked.

—

Secondary

Measure	Time frame
The study also supports the improvement of the data situation of the DiGAs in the treatment of knee injuries through the integrity of the clinical outcome of knee function. The secondary endpoint knee function is analysed at the beginning of the study, after three and after six weeks with the clinical follow-up as well as with the questionnaire ‘International Knee Documentation Committee’ (IKDC), which covers the domains of symptoms, sporting activity and knee function.	—

Measure

Time frame

The study also supports the improvement of the data situation of the DiGAs in the treatment of knee injuries through the integrity of the clinical outcome of knee function. The secondary endpoint knee function is analysed at the beginning of the study, after three and after six weeks with the clinical follow-up as well as with the questionnaire ‘International Knee Documentation Committee’ (IKDC), which covers the domains of symptoms, sporting activity and knee function.

—

Countries

Germany

Contacts

Public ContactFelix Mühlensiepen

Medizinische Hochschule Brandenburg Theodor Fontane- Zentrum für Versorgungsforschung

Felix.Muehlensiepen@mhb-fontane.de+49 163 6055860

Outcome results

None listed

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