AGT-Reha-WK study: protocol for a non-inferiority trial comparing the efficacy and costs of home-based telerehabilitation for shoulder diseases with medical exercise therapy

INTRODUCTION: Shoulder lesions rank among the top 15 diagnoses accounting for days of incapacity to work. Inpatient or full-day outpatient rehabilitation are some of the standard therapies. For sustainable rehabilitation, continuation of rehabilitation after discharge from a rehabilitation centre is vital. Besides medical exercise therapy (MET), home-based physical exercise programmes are used. To monitor exercise quantity and quality, AGT-Reha, a health-enabling technology for home rehabilitation, has been developed and evaluated in a pilot study for technical feasibility and acceptance. To integrate the digital therapeutic AGT-Reha into regular healthcare processes, an efficacy evaluation is required. METHODS AND ANALYSIS: AGT-Reha-WK is a prospective, monocentric, non-randomised, unblinded non-inferiority trial. Primary objective is to investigate whether AGT-Reha enhanced home-based exercise training is non-inferior to MET as standard aftercare. Secondary objective is to compare the costs of both therapies. Efficacy as medical success (primary outcome) is examined with regard to ability to work, return to work and sustainability of training (secondary outcomes). The outcome measure for non-inferiority is shoulder function (pain and disability) assessed by the standardised Shoulder Pain and Disability Index (SPADI). The non-inferiority margin is set to 10 points on SPADI score using a 95% CI. Subjects will be recruited at the Rehabilitation Center Bad Pyrmont, Germany. The total number of subjects should be 84 (42 per group). Treatment takes 6 months per patient. Subjects will be assessed at four time points: pre-baseline (admission to rehabilitation centre), baseline (discharge from rehabilitation centre), post-therapy and follow-up (3 months post-therapy). ETHICS AND DISSEMINATION: Ethics approval was granted by the Ethics Committee of Hannover Medical School (ethics approval no: 7313). Results of the trial are planned to be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: German Clinical Trials Register DRKS00011596. Registered 2 June 2017. Recruitment started on 3 March 2017, and it is expected to continue until December 2020. PROTOCOL VERSION: V2.0, 23 May 2018, Amendment 01: improved risk analysis, clarification of exclusion criteria to increase reproducibility, additional documentation with OpenClinica; these changes have no effect on structural equality.