Trial Outcomes & Findings for Pilot of Cognitive Stimulation Therapy for Pre-frail Stroke Survivors (NCT NCT06733103)

Last Updated: 2025-12-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Stroke Survivors Stroke Survivors	Carers Carers
Overall Study STARTED	5	5
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot of Cognitive Stimulation Therapy for Pre-frail Stroke Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stroke Survivors n=5 Participants Stroke Survivors	Carers n=5 Participants Carers	Total n=10 Participants Total of all reporting groups
Sex/Gender, Customized Female	4 Participants n=3 Participants	1 Participants n=3 Participants	5 Participants n=6 Participants
Sex/Gender, Customized Male	1 Participants n=3 Participants	4 Participants n=3 Participants	5 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=3 Participants	5 Participants n=3 Participants	10 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Educational Level O-Level/GCSE	0 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=6 Participants
Educational Level Higher Education	2 Participants n=3 Participants	2 Participants n=3 Participants	4 Participants n=6 Participants
Educational Level No qualifications	2 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=6 Participants
Educational Level Not disclosed	1 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=6 Participants
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=6 Participants
Age, Categorical >=65 years	4 Participants n=3 Participants	4 Participants n=3 Participants	8 Participants n=6 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 1 stroke survivor dropped out of intervention mid way through. Both this stroke survivor and their carer were lost to follow-up and did not take part in interviews

Outcome measures

Outcome measures
Measure	Stroke Survivors n=4 Participants Stroke Survivors	Carers n=4 Participants Carers
Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework Affective Attitude - How an individual feels about the intervention	4 Participants	4 Participants
Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework Burden - The perceived amount of effort that is required to participate in the intervention	4 Participants	4 Participants
Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework Ethicality - The extent to which the intervention had a good fit with an individual's value system	4 Participants	4 Participants
Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework Intervention Coherence - The extent to which they understand the intervention and how it works	4 Participants	4 Participants
Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework Opportunity Costs - The extent to which benefits or values must be given up for the intervention	3 Participants	4 Participants
Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework Perceived Effectiveness - The extent to which the int. is perceived as likely to achieve its purpose	4 Participants	4 Participants
Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework Self-Efficacy - The participant's confidence in their ability to participate in the intervention	4 Participants	4 Participants

Adverse Events

Stroke Survivors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carers

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stroke Survivors n=5 participants at risk Stroke Survivors	Carers n=5 participants at risk Carers
Musculoskeletal and connective tissue disorders Hip pain	0.00% 0/5 • From enrollment until end of interviews, up to 13 weeks	20.0% 1/5 • From enrollment until end of interviews, up to 13 weeks

Other adverse events

Adverse event data not reported

Additional Information

Sophie Livsey

University of East Anglia

Phone: 07947272186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place