TY - JOUR A1 - Horstmannshoff, Caren A1 - Skudlik, Stefanie A1 - Petermann, Jenny A1 - Kiesel, Theresia A1 - Döringer, Tobias A1 - Crispin, Alexander A1 - Hermsdörfer, Joachim A1 - Köberlein‑Neu, Juliane A1 - Jahn, Klaus A1 - Schädler, Stefan A1 - Bauer, Petra A1 - Voigt, Karen A1 - Müller, Martin T1 - Effectiveness of an evidence-based care pathway to improve mobility and participation in older patients with vertigo and balance disorders in primary care (MobilE-PHY2): study protocol for a multicentre cluster-randomised controlled trial JF - BMC Trials N2 - Background Vertigo, dizziness or balance disorders (VDB) are common leading symptoms in older people, which can have a negative impact on their mobility and participation in daily live, yet, diagnosis is challenging and specific treatment is often insufficient. An evidence-based, multidisciplinary care pathway (CPW) in primary care was developed and pilot tested in a previous study. The aim of the present study is to evaluate the effectiveness and safety of the CPW in terms of improving mobility and participation in community-dwelling older people with VDB in primary care. Methods For this multicentre cluster randomised controlled clinic trial, general practitioners (GP) will be recruited in two regions of Germany. A total of 120 patients over 60 years old with VDB will be included. The intervention is an algorithmized CPW. GPs receive a checklist for standardise clinical decision making regarding diagnostic screening and treatment of VDB. Physiotherapists (PT) receive a decision tree for evidence-based physiotherapeutic clinical reasoning and treatment of VDB. Implementation strategies comprises educational trainings as well as a workshop to give a platform for exchange for the GPs and PTs, an information meeting and a pocket card for home care nurses and informal caregivers and telephone peer counselling to give all participants the capability, opportunity and the motivation to apply the intervention. In order to ensure an optimised usual care in the control group, GPs get an information meeting addressing the national guideline. The primary outcome is the impact of VDB on participation and mobility of patients after 6 month follow-up, assessed using the Dizziness Handicap Inventory (DHI) questionnaire. Secondary outcomes are physical activity, static and dynamic balance, falls and fear of falling as well as quality of life. We will also evaluate safety and health economic aspects of the intervention. Behavioural changes of the participants as well as barriers, facilitating factors and mechanisms of impact of the implementation will be investigated with a comprehensive process evaluation in a mixed-methods design. Discussion With our results, we aim to improve evidence-based health care of community-dwelling older people with VDB in primary care. KW - Dizziness KW - Vertigo KW - Balance disorder KW - Complex intervention KW - Primary care KW - Care pathway KW - Multicentre cluster randomised controlled trial KW - Mobility KW - Physiotherapy Y1 - 2023 UR - https://doi.org/10.1186/s13063-022-07017-x VL - 24 SP - 91 ER - TY - JOUR A1 - Nguyen, Natalie A1 - Thalhammer, Regina A1 - Beutner, Katrin A1 - Saal, Susanne A1 - Servaty, Ricarda A1 - Klingshirn, Hanna A1 - Icks, Andrea A1 - Freyberg, Kristina A1 - Vomhof, Markus A1 - Mansmann, Ulrich A1 - Le, Lien A1 - Müller, Martin A1 - Meyer, Gabriele T1 - Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185] JF - Trials N2 - Background: Nursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study. Methods/design: This multicentre cluster-randomised controlled trial will be conducted in 32 nursing homes spread over two regions of Germany. A total of 578 residents over 65 years old with joint contractures will be included. To compare the effect of the PECAN intervention with optimised standard care (usual care and an information session), randomisation will take place at a cluster level. The individually tailored intervention was designed using the biopsychosocial model in the International Classification of Functioning, Disability and Health (ICF) to reduce activity limitations and participation restrictions resulting from existing joint contractures by addressing barriers and by strengthening supportive factors on an individual level and an organisational level. The implementation strategy comprises a facilitators’ workshop, a peer mentoring approach including a peer mentor visit and telephone peer counselling, an in-house information event, an information session for the nursing team and a training session on collegial consultation for the facilitators. The in-house information event will also take place in the nursing homes of the control group. The primary outcome is the residents’ participation and activities after 12 months of follow-up as assessed using the PaArticular Scales. The secondary outcome is the residents’ quality of life. A cost-effectiveness analysis (costs per additional resident who experienced a decrease of ten points in the participation or activities subscale of the PaArticular Scales) and a cost–utility analysis (costs per additional quality adjusted life year) will be conducted. We will investigate barriers and facilitators in a comprehensive process evaluation. Discussion: We expect a clinically relevant improvement of participation and activities in residents with joint contractures. Our findings will provide important insights regarding participation in the situation of the affected individuals. KW - Joint contractures KW - Participation KW - Activities KW - Nursing homes KW - International Classification of Functioning KW - Disability and Health (ICF) KW - Complex intervention KW - Multicentre cluster randomised controlled trial Y1 - 2019 UR - https://doi.org/10.1186/s13063-019-3384-6 VL - 20 SP - 305 ER -