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临床试验/NCT06042907
NCT06042907已完成不适用

Development, Validation and Evaluation of the Feasibility of the Observational Risk Assessment of Contractures (Longitudinal Evaluation) Tool: The ORACLE Study

Bournemouth University8 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2023年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
224
试验地点
8
主要终点
Observational Risk Assessment for Contractures: Longitudinal Evaluation (ORACLE)

研究概览

简要总结

The Observational Risk Assessment for Contractures- Longitudinal Evaluation (ORACLE) is a risk assessment tool for contractures. The tool was originally designed and developed by a group of multidisciplinary health professionals within Dorset Healthcare University NHS Foundation Trust (DHUFT). Bournemouth University and DHUFT sponsored a match funded studentship to establish the academic validation of the tool.

The results from the previously conducted studies (Phase One) as part of this project: (i) a systematic review of the literature and an (ii) online Delphi survey with field experts provided initial evidence for further development, content validity, and modification of the tool.

The current study (Phase Two) aims to establish the psychometric validation, acceptability, and usability of the modified tool through formal testing on adult care home residents in Dorset. It consists of two streams of work: Stream A aims to establish the psychometric validation by completing the ORACLE assessments on adult care home residents. The assessments will be performed by the care home staff. In Stream B, a realist evaluation will be performed to explore the usability and practicality of ORACLE with selected care home managers and staff who were involved in organising and completing the assessments on ORACLE respectively.

The results from this two-phase design will then inform further revisions of the tool if required.

详细描述

Joint contractures are described as any degree of reduction in the passive range of motion within a joint due to muscle or connective tissue shortening eventually leading to structural abnormalities within the affected joint. ). This can lead to further deterioration in limb and joint flexibility, mobility, and activities of daily living (ADL's).

It has been reported that the care home residents spend most of their time remaining sedentary. Reduced mobility or lack of physical activity adversely affects the residents' physical and psychological well-being of the residents, including reduced motivation to engage in physical and social activities, pain, increased risk of pressure sores, contractures, and physical dependency.

Structured risk assessments play an important role in referring patients to the appropriate health care practitioner and enacting early treatment strategies to reduce the risk of the condition progressing. However, there is a clear lack of a standardised, evidence-based measure that can actively identify the risk of contractures and trigger appropriate and timely referrals to healthcare professionals.

The tool, Observational Risk Assessment for Contractures- Longitudinal Evaluation (ORACLE) was initially designed with the aim to address the gap mentioned above by a group of healthcare professionals (physiotherapists, occupational therapists, and nurses within Dorset Healthcare, Bournemouth Borough Council, Poole Borough Council, Dorset County Council, and Dorset CCG. The working party discussed the potential causes and factors associated with contracture development and/or progression based on their clinical experience and developed relevant themes to define the construct of the tool. The original construct developed underwent a series of transformations before a face-to-face consensus over a series of meetings to finally include eight items in the tool.

To establish the academic validation of the tool before widespread use and implementation, Dorset Health Care collaborated with Bournemouth University and sponsored a match-funded PhD Studentship. The PhD project has been structured into two main phases: Phase One: content validation and phase II: external validation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Care home residents aged 18 or above residing in residential and/ or nursing care homes located in Dorset.

排除标准

  • Adults receiving end of life care

结局指标

主要结局

Observational Risk Assessment for Contractures: Longitudinal Evaluation (ORACLE)

时间窗: ORACLE (approx 10 minutes) will be administered thrice (twice by the same carer and once by a different carer) with a period of a 12-hour shift.

The primary outcome measure in this study will be the newly developed contracture risk assessment tool (ORACLE) to evaluate its validity, reliability and acceptability in care homes

次要结局

  • Barthel Index(Barthel Index will be administered once (approx 10 minutes) in a 12 hour shift)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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