Evaluation of the patient-accompanying app “alley ortho companion” for patients with osteoarthritis of the knee and hip: study protocol for a randomized controlled multi-center trial
Authors: Strahl André , Graichen Heiko , Haas Holger , Hube Robert , Perka Carsten , Rolvien Tim , Hubert Jan 
Published: August 2022

Abstract
Background
Osteoarthritis (OA) is one of the most common disabilities in the elderly. When conservative management fails, total joint arthroplasty (TJA) is the treatment of choice for end-stage OA. Since quality and durability of implants has steadily improved, pre -and postsurgical processes moved into the focus of research. Hence, eHealth approaches offer an opportunity to provide a more available continuity of care. Regarding individualized pre-, peri-, and postsurgical stages, eHealth is expected to improve patient engagement, self-care, and outcomes across the surgical pathway. Aim of this study is to evaluate the effectiveness of the eHealth application “alley” as an adjuvant intervention to TJA. The app provides comprehensive information to empower patient with hip or knee OA to prepare and accompany them for their TJA surgery. Our primary hypothesis is that the pre- and postoperative adjuvant use of the eHealth application “alley” (intervention group, IG) leads to improved functional outcome.

Methods
Prospective, randomized, controlled, multi-center trial including n = 200 patients diagnosed with hip and n = 200 patients with knee OA (n = 200) scheduled for TJA. Patients of both groups will be randomly assigned to one of two study arms. Patients in the intervention group will receive access to the functions of the “alley” app. The app presents informative (e.g., information about osteoarthritis), organizational (e.g., information about medical rehabilitation), and emotional/empowerment (e.g., information about the relationship between mood and pain) content. Patients evaluate their condition and functional level by means of standardized digitally questionnaires. Patients in the control group will not receive any functions of the app. Assessments will be performed at baseline before, 10 days after, 1 months after, 3 months after, 6 months after, and 12 months after TJA. Primary outcome is change from baseline measured by the Hip Osteoarthritis Outcome Score or Knee injury and Osteoarthritis Outcome Score 3 months after TJA. The statistical analysis (t-test for independent variables with effect size Cohen’s d) is performed separately for patients with TKA and THA.

Discussion
Overall, the study aims to improve the understanding of the benefits of eHealth applications in the treatment of elderly patients with knee or hip arthroplasty. The approach is novel since a health care companion is combined with a digital information platform enabling direct and continuous feedback from the patients to the therapeutic treatment team. As the study investigate the effectiveness under everyday conditions, it is not feasible to control whether the patients in the IG read the educational information of the app respectively the control group consume additional information from other sources. However, this increases the external validity of the study if significant effects for the app can be demonstrated.

Trial registration
German Clinical Trials Register: DRKS00025608. Registered on 21 June 2021.