Outcome Description | Instrument [ref] | Sample | Collection points |
---|---|---|---|
Patient characteristics | |||
Sociodemographic data, anthropometric data, other baseline data | Variables and definitions according to the International Standard Set of Outcome measures for patients with hip or knee OA [29] | IG, C | t0 |
Technical affinity towards electronic devices | Self-report questionnaire on subjective technical affinity (Technical Affinity – Electronic Devices (TA-EG)) [31] | IG, C | t0 |
Outcome expectations | Expectation for Treatment Scale (ETS, German version) [30] | IG, C | t0 |
Fear of Movement | Tampa Scale for Kinesiophobia (German Version, TSK-GV) [32] | IG, C | t0 |
Health outcome measures | |||
Patient reported outcome measures (PROMS) | |||
Subscale knee pain (Co1° outcome) | Knee Osteoarthritis Outcome Score KOOS [24, 25]: A disease related questionnaire asking for patient’s opinion about their complaints | IG, C | t0, t1 |
Subscale function in daily living (ADL) (Co1° outcome) | Knee Osteoarthritis Outcome Score KOOS [24, 25]: A disease related questionnaire asking for patient’s opinion about their complaints | IG, C | t0, t1 |
Subscales symptoms, function in sport and recreation (Sport/Rec), knee-related quality of life (QoL) | Knee Osteoarthritis Outcome Score KOOS [24, 25]: A disease related questionnaire asking for patient’s opinion about their complaints | IG, C | t0, t1 |
Patient’s global assessment | Patient Global Assessment of osteoarthritis – Knee [33] | IG, C | t0, t1 |
Health related quality of life | VR-12 Questionnaire [34] | IG, C | t0, t1 |
Subjective assessment of overall change, change in pain and function | Transition question according to Angst, Benz [35] | IG, C | t1 |
Objective outcome measures | |||
Functional strength measure for the lower extremities | 30-s Chair Stand Test [36] | IG, C | t0, t1 |
Concomitant care | |||
Treatment progression | Variables and definitions according to the International Standard Set of Outcome measures for patients with hip or knee OA [29] | IG, C | t0, t1 |
Care utilization | IG, C | t0, t1 + after 4 and 8 weeks | |
Perceived human-digital interaction, patient satisfaction | |||
Usability of the app | - mHealth App Usability Questionnaire (MAUQ) [37] - 1 item from Harder, Holroyd [38] (Item B1) | IG | t1 |
Patient satisfaction with the app | Patient satisfaction questionnaire (ZUF-8) [39] | IG | t1 |
Patient satisfaction with the results of the treatment | Satisfaction with the results [29] | IG, C | t1 |
Logfiles | |||
Adherence to exercise | Logfiles relate to adherence to overall training sessions and each exercise | IG | continuously during intervention phase |
Rating of perceived exertion (RPE) during exercising | Entry into the app after each exercise and after the training using an adapted RPE-Scale (NRS 0–10) | IG | continuously during intervention phase |
Rating of perceived pain before, during and after exercising | Entry into the app before/after the training and after each exercise using a faces pain scale referring to the numbers 0, 2, 4, 6, 8, 10 | IG | continuously during intervention phase |
Safety aspects | |||
Exercise related pain | Frequency, duration, intensity | IG, C | t1 |
Adverse event report | Direct contact to study personal | IG, C | if reported |