Introduction
Hip and knee osteoarthritis are associated with functional limitations, pain and restrictions in quality of life and the ability to work. Furthermore, with growing prevalence, osteoarthritis is increasingly causing (in)direct costs. Guidelines recommend exercise therapy and education as primary treatment strategies. Available options for treatment based on physical activity promotion and lifestyle change are often insufficiently provided and used. In addition, the quality of current exercise programmes often does not meet the changing care needs of older people with comorbidities and exercise adherence is a challenge beyond personal physiotherapy. The main objective of this study is to investigate the short- and long-term (cost-)effectiveness of the SmArt-E programme in people with hip and/or knee osteoarthritis in terms of pain and physical functioning compared to usual care.
Methods
This study is designed as a multicentre randomized controlled trial with a target sample size of 330 patients. The intervention is based on the e-Exercise intervention from the Netherlands, consists of a training and education programme and is conducted as a blended care intervention over 12 months. We use an app to support independent training and the development of self-management skills. The primary and secondary hypotheses are that participants in the SmArt-E intervention will have less pain (numerical rating scale) and better physical functioning (Hip Disability and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score) compared to participants in the usual care group after 12 and 3 months. Other secondary outcomes are based on domains of the Osteoarthritis Research Society International (OARSI). The study will be accompanied by a process evaluation.
Discussion
After a positive evaluation, SmArt-E can be offered in usual care, flexibly addressing different care situations. The desired sustainability and the support of the participants’ behavioural change are initiated via the app through audio-visual contact with their physiotherapists. Furthermore, the app supports the repetition and consolidation of learned training and educational content. For people with osteoarthritis, the new form of care with proven effectiveness can lead to a reduction in underuse and misuse of care as well as contribute to a reduction in (in)direct costs.
Trial registration
German Clinical Trials Register, DRKS00028477. Registered on August 10, 2022.
In Germany, the situation of health care services for children and adolescents with gender dysphoria is insufficient. In 2006 a specialized multiprofessional outpatient clinic was founded at the University Medical Center Hamburg-Eppendorf. Goals were improvement of health services for gender dysphoric children, development of treatment concepts, and gain of knowledge through research. After finishing a thorough interdisciplinary assessment an individualized, case-by-case treatment starts. Besides psychotherapy an interdisciplinary treatment (e. g. puberty suppression and cross-sex hormones) is provided if indicated. During childhood a watchful waiting and carefully observing attitude is necessary. If a marked increase of gender dysphoria occurs during the first phases of puberty development, puberty suppression and later cross sex-hormones might be indicated.
The clinical treatment of children and adolescents with gender dysphoria is still a controversial issue. The aim of this study was to get an overview of the knowledge and experience of international experts and to highlight shared views as well as differences in theoretical convictions and treatment approaches. Half-structured, guide-line based interviews were carried out with international experts in the field. The interviews were analyzed using qualitative content analysis (Mayring, 2010).