Leroi Iracema, Pye Annie, Armitage Christopher J, Charalambous Anna Pavlina, Constantinidou Fofi, Helmer Catherine, Himmelsbach Ines, Marié Sarah, Miah Jahanara, Parsons Suzanne, Regan Jemma, Thodi Chryssoula, Wolski Lucas, Yohannes Abebaw Mengistu, Dawes Piers
Division of Neuroscience and Experimental Psychology, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL UK.
Manchester Centre for Health Psychology, School of Psychological Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.
Pilot Feasibility Stud. 2017 Sep 11;3:38. doi: 10.1186/s40814-017-0176-1. eCollection 2017.
Hearing and vision impairments are among the most common and disabling comorbidities in people living with dementia. Intervening to improve sensory function could be a means by which the lives of people living with dementia may be improved. However, very few studies have tried to ameliorate outcomes in dementia by improving sensory function. This paper describes the multi-step development of a new intervention designed to support hearing and vision function in people living with dementia in their own homes. At the end of the development programme, it is anticipated that a 'sensory support' package will be ready for testing in a full scale randomised controlled trial.
This programme is based on the process of 'intervention mapping' and comprises four integrated steps, designed to address the following: (1) scoping the gaps in understanding, awareness and service provision for the hearing and/or vision impairment care needs of people with dementia using a systematic literature review and Expert Reference Group; (2) investigating the support care needs through a literature search, stakeholder surveys, focus groups, semi-structured interviews and an Expert Reference Group, leading to a prototype sensory support package; (3) refining the prototype by additional input from stakeholders using focus groups and semi-structured interviews; and (4) field testing the draft intervention using an open-labelled, non-randomised feasibility study, integrating feedback from people with dementia and their significant others to develop the final intervention ready for full scale definitive trialling. Input from the 'patient and public voice' is a cornerstone of the work and will interlink with each step of the development process. The programme will take place in study centres in Manchester, Nicosia and Bordeaux.
Quantitative and qualitative data analyses will be employed, dependent upon the sub-studies in question. Data from the steps will be integrated with consideration given to weighting of evidence for each step of the programme. This programme represents the logical development of a complex intervention to fulfil an unmet need. It is based on a theoretical framework and will lead to a subsequent full scale efficacy trial. The challenges in integrating the data and addressing the contextual issues across study sites will be scrutinised.
听力和视力障碍是痴呆症患者中最常见且导致残疾的共病之一。通过干预改善感官功能可能是改善痴呆症患者生活的一种方式。然而，很少有研究试图通过改善感官功能来改善痴呆症的预后。本文描述了一种旨在支持痴呆症患者在家中听力和视力功能的新干预措施的多步骤开发过程。在开发计划结束时，预计将准备好一个“感官支持”包，用于在全面随机对照试验中进行测试。
该计划基于“干预映射”过程，包括四个综合步骤，旨在解决以下问题：（1）通过系统的文献综述和专家参考小组，确定痴呆症患者听力和/或视力障碍护理需求在理解、认识和服务提供方面的差距；（2）通过文献检索、利益相关者调查、焦点小组、半结构化访谈和专家参考小组，调查支持护理需求，从而形成一个感官支持包原型；（3）通过焦点小组和半结构化访谈，利用利益相关者的额外意见完善原型；（4）使用开放标签、非随机可行性研究对干预草案进行实地测试，整合痴呆症患者及其重要他人的反馈，以开发最终干预措施，准备进行全面的确定性试验。“患者和公众声音”的意见是这项工作的基石，并将与开发过程的每个步骤相互关联。该计划将在曼彻斯特、尼科西亚和波尔多的研究中心进行。
将根据相关子研究采用定量和定性数据分析。各步骤的数据将在考虑该计划每个步骤证据权重的基础上进行整合。该计划代表了一项复杂干预措施的合理发展，以满足未满足的需求。它基于一个理论框架，并将导致随后的全面疗效试验。将仔细审查整合数据和解决各研究地点背景问题方面的挑战。
