Pilot of Cognitive Stimulation Therapy for Pre-frail Stroke Survivors

NCT06733103 | Completed Results

• 1 other identifier: 335493
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Frailty; Carers

Keywords

FIESTO; sCST

Outcome Measures

Primary Outcomes (1)

• Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework

  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.

  4 weeks

Study Arms (1)

sCST Intervention Group

EXPERIMENTAL

There is only one arm of this intervention, it involves stroke survivors attending a cognitive stimulation group designed for post-stroke frailty. This involves strategies and psychoeducation and take-home sheets for stroke survivors and their carers. After the group is finished, stroke survivors will attend interviews and the findings of these interviews will be analysed through the theoretical framework of accepatability. The same will be the case for carers.

Behavioral: Stroke Cognitive Behavioural Therapy

Interventions

Stroke Cognitive Behavioural Therapy BEHAVIORAL

This is the only intervention in this clinical (feasibility) study

sCST Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of East Anglia: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Frailty

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sophie Livsey
• Organization: University of East Anglia

sophie.livsey1@nhs.net

07947272186

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 13, 2024
• Study Start: July 9, 2024
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2024-08

Locations

GB (1)