Burroughs Heather, Bartlam Bernadette, Ray Mo, Kingstone Tom, Shepherd Tom, Ogollah Reuben, Proctor Janine, Waheed Waquas, Bower Peter, Bullock Peter, Lovell Karina, Gilbody Simon, Bailey Della, Butler-Whalley Stephanie, Chew-Graham Carolyn
Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.
Department School of Health and Social Care, Lincoln University, Lincoln, UK.
Trials. 2018 Mar 7;19(1):172. doi: 10.1186/s13063-018-2550-6.
Anxiety and depression are common among older people, with up to 20% reporting such symptoms, and the prevalence increases with co-morbid chronic physical health problems. Access to treatment for anxiety and depression in this population is poor due to a combination of factors at the level of patient, practitioner and healthcare system. There is evidence to suggest that older people with anxiety and/or depression may benefit both from one-to-one interventions and group social or educational activities, which reduce loneliness, are participatory and offer some activity. Non-traditional providers (support workers) working within third-sector (voluntary) organisations are a valuable source of expertise within the community but are under-utilised by primary care practitioners. Such a resource could increase access to care, and be less stigmatising and more acceptable for older people.
The study is in three phases and this paper describes the protocol for phase III, which will evaluate the feasibility of recruiting general practices and patients into the study, and determine whether support workers can deliver the intervention to older people with sufficient fidelity and whether this approach is acceptable to patients, general practitioners and the third-sector providers. Phase III of the NOTEPAD study is a randomised controlled trial (RCT) that is individually randomised. It recruited participants from approximately six general practices in the UK. In total, 100 participants aged 65 years and over who score 10 or more on PHQ9 or GAD7 for anxiety or depression will be recruited and randomised to the intervention or usual general practice care. A mixed methods approach will be used and follow-up will be conducted 12 weeks post-randomisation.
This study will inform the design and methods of a future full-scale RCT.
ISRCTN, ID: ISRCTN16318986 . Registered 10 November 2016. The ISRCTN registration is in line with the World Health Organization Trial Registration Data Set. The present paper represents the original version of the protocol. Any changes to the protocol will be communicated to ISRCTN.
焦虑和抑郁在老年人中很常见，高达20%的老年人报告有此类症状，且患病率会随着慢性身体健康问题的合并症而增加。由于患者、从业者和医疗保健系统层面的多种因素，该人群中焦虑和抑郁的治疗可及性较差。有证据表明，患有焦虑和/或抑郁的老年人可能会从一对一干预以及团体社交或教育活动中受益，这些活动可以减少孤独感，具有参与性并提供一些活动。在第三部门（志愿）组织工作的非传统提供者（支持工作者）是社区内宝贵的专业知识来源，但初级保健从业者对其利用不足。这样一种资源可以增加获得护理的机会，对老年人来说耻辱感更低且更容易接受。
该研究分为三个阶段，本文描述了第三阶段的方案，该阶段将评估招募全科医疗和患者参与研究的可行性，并确定支持工作者是否能够以足够的保真度向老年人提供干预措施，以及这种方法是否为患者、全科医生和第三部门提供者所接受。NOTEPAD研究的第三阶段是一项个体随机化的随机对照试验（RCT）。它从英国大约六个全科医疗中招募参与者。总共将招募100名年龄在65岁及以上、在PHQ9或GAD7焦虑或抑郁量表上得分10分或更高的参与者，并将其随机分配到干预组或常规全科医疗护理组。将采用混合方法，并在随机化后12周进行随访。
本研究将为未来全面RCT的设计和方法提供信息。
ISRCTN，编号：ISRCTN16318986。于2016年11月10日注册。ISRCTN注册符合世界卫生组织试验注册数据集。本文代表该方案的原始版本。对该方案的任何更改都将通知ISRCTN。
