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Orgeta V, Leung P, Yates L, et al. Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Southampton (UK): NIHR Journals Library; 2015 Aug. (Health Technology Assessment, No. 19.64.)

Cover of Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial

Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial.

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Chapter 3Final intervention tested in the main trial

The iCST intervention was developed primarily as a home-based programme of structured iCST for people with dementia to be delivered by carers. Dyads completed up to 3 30-minute sessions per week over 25 weeks. The programme consisted of a total of 75 themed activity sessions, including being creative, number games and art discussion (Box 1), which were intended to provide opportunities for general cognitive stimulation via a choice of specific activities. In order to accommodate personal interests, dyads were encouraged to adapt the materials provided and to take a flexible approach in relation to choosing sessions, such as omitting any activities not suited to their interests, or revisiting activities that were particularly enjoyable. Each iCST session followed a consistent structure, where the first few minutes involved engaging in discussions of orientation information prompted by family carers (i.e. day, date, weather, time, location), followed by discussion of current events (i.e. a news story, a community event or family occasion) and the main iCST activity (15–20 minutes).

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BOX 1

Themes of iCST sessions My life.

We used recent guidelines23 aimed at improving the description of interventions evaluated in RCTs consistent with the Consolidated Standards of Reporting Trials (CONSORT) 2010 and Standard Protocol Items: Recommendations for Interventional Trials statements, which enables replication of the specific intervention tested. An overview of the iCST intervention using the Template for Intervention Description and Replication checklist and guide is presented in Table 1.

TABLE 1

TABLE 1

Template for Intervention Description and Replication checklist describing the iCST intervention

Contents of individual cognitive stimulation therapy

Dyads were provided with the iCST manual, the iCST activity workbook, two carer diaries and the iCST toolkit. The iCST manual provides guidance on how to run the iCST sessions, the key principles of iCST (Box 2) and guidance on activities. This manual was disseminated at the ninth UK Dementia Congress and has been published.24 The iCST activity workbook contains paper-based resources for activities suggested in the manual, such as word puzzles and images to stimulate discussion.

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BOX 2

Individual cognitive stimulation therapy key principles iCST should:

Carer training

Carers were trained in their home by an unblinded researcher. A standardised training package was developed with interactive features, including a role-play exercise and the opportunity to see clips of group CST activities. The first part of the training session introduces the dyad to the iCST materials (manual, activity workbook, toolkit and carer diaries) and explains the session structure and key principles. Carers were encouraged to take part in a role-play exercise with the researcher, developed to demonstrate ‘good’ and ‘bad’ practice in iCST. In the final part of iCST training, family carers were invited to deliver their first iCST session with support from the unblinded researcher, who provided feedback afterwards. Where multiple family carers were involved in delivering the programme, the researcher invited them to be trained with the main carer.

Individual cognitive stimulation therapy support for carers

An unblinded researcher provided dyads with telephone support throughout their participation, providing weekly, fortnightly or monthly telephone support depending on carer needs and preference. Additional monitoring visits took place at 12 weeks and 25 weeks, which were aimed at collecting the iCST carer diaries, providing further support if necessary and completing measures of compliance. There were a total of 21 unblinded researchers supporting carers, of whom 81% were qualified professionals working in the local NHS trusts. Among qualified professionals, the majority were nurses (n = 13) or clinical psychologists (n = 3), with one member of staff being a qualified occupational therapist. The remaining staff were clinical studies officers (n = 2) or research assistants (n = 2). All unblinded researchers supporting carers received training in iCST.

Individual cognitive stimulation therapy fidelity

To ensure that psychosocial interventions can be replicated, and to ensure that the treatment delivered was indeed the treatment intended (known as ‘treatment integrity’),25 iCST components were described in detail in a treatment protocol. This protocol formed the basis of training of all unblinded researchers supporting and training family carers in delivering iCST. iCST diaries provided a method of tracking compliance to the programme, whereby in each theme, carers were required to record whether or not the session had been completed, the date of completion and their relative’s interest, enjoyment and communication. Space was provided for dyads to provide any additional comments related to the sessions. The progress of dyads and compliance to the programme was also measured during support activities via treatment questionnaires during both the telephone support and visits. A telephone support questionnaire was used to gather data on the average number of sessions completed per week, average duration of sessions, average time spent preparing and any difficulties encountered. Carers completed a self-report measure of confidence and knowledge in the delivery of iCST, level of engagement of the person with dementia, use of iCST principles and satisfaction with the support provided in treatment visits.

Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Orgeta et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK311131

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