Adapted Cognitive Stimulation Therapy (CST) for Pre-frail Stroke Survivors: A Non-randomised, Acceptability and Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework
研究概览
简要总结
Frailty is described as a type of vulnerability where one can struggle to recover fully from things that can put stress on one's body, e.g., cold weather or bronchitis. This can lead to negative health outcomes and is linked with early death, particularly if the person has had a stroke. Frailty was first operationalised by Fried et al. (2001) as the presence of at least three out of the following five clinical indicators: unintentional weight loss, exhaustion, weakness, slow walking speed and low level of physical activity. They also defined 'intermediate frailty status', now referred to as 'pre-frailty', as the occurrence of one or two of the five criteria.
An alternative perspective on frailty was proposed by Mitnitski et al. (2001), suggesting it refers to the number of health deficits an individual has accumulated. Individuals assessed as pre-frail have an increased risk of becoming frail in the following few years, and those assessed as frail are more likely to die (Gill et al., 2006). However, frailty is potentially reversible at the pre-frail stage, making pre-frailty an important target for intervention (Gill et al., 2006).
A promising approach to the reversal of pre-frailty is multicomponent interventions consisting of a physical exercise intervention combined with nutritional, cognitive, social and/or other interventions, which have been shown to reduce frailty ratings in pre-frail older adults (aged 65 or above) (Apóstolo et al., 2018; Dedeyne et al., 2017; Tam et al., 2022).
Interestingly, cognitive training interventions alone can also have a positive impact on frailty ratings (Ng et al., 2015), indicating a potential role for psychologically informed interventions in frailty management. If multicomponent interventions reverse frailty in pre-frail older adult populations, it is possible they may also reverse frailty in pre-frail stroke populations and help to reduce the risk of associated adverse outcomes.
There is limited consistency across the existing literature of multicomponent interventions regarding the mode of delivery, content, and duration of the cognitive component (e.g. Apóstolo et al., 2019; Chen et al., 2020; Murukesu et al., 2020; Ng et al., 2015). However, some formats of the cognitive interventions used share similarities with Cognitive Stimulation Therapy (CST; Spector et al., 2003). CST is an intervention for individuals with mild to moderate dementia and is recommended by the National Institute of Health and Care Excellence [NICE] (2018); it has been researched globally and found to improve cognition, quality of life, well-being, mood and activities of daily living (Aguirre et al., 2013; Lobbia et al., 2019).
CST might, therefore, provide a good basis for the cognitive training component of a multicomponent frailty intervention, including within stroke populations. However, there is currently no research applying CST in a population where stroke is the primary diagnosis. We therefore want to find out if an adapted version of CST will be a feasible and acceptable intervention for stroke survivors and their informal carers, who have been found to spend over 30 hours per week supporting the stroke survivor (Deloitte Access Economics, 2020).
The thoughts of the stroke survivors (who will have attended the pilot group intervention) and their carers (who will have not attended the intervention but will have supported the stroke survivor to attend and complete between session activities) will be gathered from focus groups. We will explore their thoughts on the feasibility and acceptability of the intervention (fore example, whether it can be reasonably carried out and is felt to be appropriate).
This study is part of a larger research project on Frailty and its Effects on Stroke Treatments and Outcomes (FIESTO) and the findings will inform the neuropsychological component used in a feasibility randomised control trial investigating a multicomponent intervention for pre-frail stroke survivors.
详细描述
Purpose and Design Frailty is a state of vulnerability characterised by multi-system decline in physiological reserves needed to maintain homeostasis following a stressor e.g., cold weather or bronchitis (Morley et al., 2013; Fried et al., 2001; Campbell & Buchner, 1997). Fried et al (2001) operationalise frailty as the presence of three or more indicators in terms of shrinking (unintentional weight loss of 10 lbs or more in the last year), self-reported exhaustion, weakness of grip strength, slowness of walking speed, or low physical activity. Poorer functional outcomes such as higher rates of institutionalisation, and increased rates of mortality and illness are common (Wallis et al., 2015; Fried et al., 2001). Pre-frailty is the presence of one or two indicators and is associated with elevated risk of adverse outcomes and of declining into frailty (Fried et al., 2001). Gill et al. (2006) found people who were pre-frail were likely to transition to frailty, and people who were frail were three to five times more likely to die over the course of their 54-month study.
Importantly, however, they found frailty can be reversed with interventions delivered at the pre-frail stage (Fried et al., 2001; Ng et al., 2015; Gill et al., 2006).
Promising approaches to the reversal of pre-frailty and associated negative outcomes are multicomponent interventions that consist of a physical exercise intervention combined with nutritional, cognitive, social and/or other interventions. These have been shown to reduce frailty ratings in pre-frail older adults (aged 65 or above) (Apóstolo et al., 2018; Dedeyne et al., 2017; Tam et al., 2022). Interestingly, cognitive training interventions alone can also have a positive impact on frailty ratings (Ng et al., 2015), indicating a potential role for psychologically informed interventions in frailty management. Given multicomponent interventions can reverse frailty in pre-frail older adult populations, it is possible they may also reverse frailty in pre-frail stroke populations and help to reduce the risk of associated adverse outcomes.
Dr Nicholas Evans, Honorary Consultant in Stroke Medicine at Addenbrooke's Hospital and Senior Clinical Lecturer at the University of Cambridge, is leading the 'Frailty and Its Effects on Stroke Treatments and Outcomes' (FIESTO) project, supported by the Stroke Association. This will include a feasibility Randomised Controlled Trial (RCT) of a multicomponent intervention consisting of physical, cognitive and nutritional components for pre-frail stroke survivors in preparation for a full-scale RCT. However, initial work is required to develop each individual component of the overall multicomponent intervention.
There is limited consistency across the existing literature of multicomponent interventions regarding the mode of delivery, content, and duration of the cognitive training component (e.g. Apóstolo et al., 2019; Chen et al., 2020; Murukesu et al., 2020; Ng et al., 2015). However, some formats of cognitive training used in these interventions share similarities with Cognitive Stimulation Therapy (CST; Spector et al., 2003). CST is an intervention for individuals with mild to moderate dementia and is recommended by the National Institute of Health and Care Excellence [NICE] (2018); it has been researched globally and found to improve cognition, quality of life, well-being, mood and activities of daily living (Aguirre et al., 2013; Lobbia et al., 2019). CST might, therefore, provide a good basis for the cognitive training component of a multicomponent frailty intervention, including within stroke populations. However, there is currently no research applying CST in a population where stroke is the primary diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stroke Survivors Inclusion Criteria:
- •18+ years old
- •Had a stroke 12 months ago, or less
- •Due to be discharged back home before the adapted CST group starts
- •Experiencing a loss of physical resilience as a result of your stroke
- •Experiencing some difficulty with your memory or thinking as a result of your stroke
- •Have a family member or friend who regularly supports you and is willing to take part in a connected research study
- •Have the ability to speak and read the English language to participate fully in the adapted CST group and online interview
- •Stroke Survivors
排除标准
- •Have significant difficulties with language, memory or thinking that would take taking part too difficult
- •Are not able to independently make the decision about whether you would like to take part
- •Have a diagnosis of dementia
- •Do not have access to a computer, laptop or tablet from which you can access an online interview
- •Carers Inclusion Criteria
- •Are 18+ years old
- •Regularly support someone who has survived a stroke
- •Have the ability to speak and read the English language to engage fully in the CST take-home activities and online interview
- •Are able to independently make the decision about whether you would like to take part in the study
- •Carers Exclusion Criteria
- •Do not have access to a computer, laptop or tablet from which you can access an online interview
- •Are a professional carer for the person you support
- •Are being investigated by the safeguarding team
结局指标
主要结局
Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework
时间窗: 4 weeks
Semi-structured interviews were carried out using a topic guide based on the Theoretical Framework of Acceptability (TFA; Sekhon et al., 2017). The resulting data were analysed using Framework Analysis, using the TFA as the guiding framework. The transcripts were coded both deductively and inductively. Deductive codes were based on the definitions of the 7 constructs of the TFA outlined by Sekhon et al. (2017). Any meaningful data relating to acceptability that did not fit within these definitions were inductively coded. Because the data for stroke survivors was analysed completely separately from that for carers for the purposes of the researchers producing two independent doctoral theses, the only data that can be compared is that which resulted from the deductive coding. Therefore, the data reported below reports the number of participants who provided meaningful data relating to each of the 7 constructs of the TFA.
次要结局
未报告次要终点
