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. 2023 Jun 29;2023(6):CD013388. doi: 10.1002/14651858.CD013388.pub2

Clarkson 2022.

Study characteristics
Methods Multicentre, pragmatic, single‐blind randomised controlled trial comparing the effects of introducing memory aids and guidance by dementia support practitioners against treatment as usual
Participants 469 people with mild‐to‐moderate dementia and their informal carers
Interventions DESCANT intervention: a manualised 4‐week intervention aiming to improve the abilities, functioning, and independence. A trained dementia support practitioner offered up to 6 hours of guidance and support in using memory aids.
Treatment as usual: usual care from memory clinics that involved post‐diagnostic counselling and advice from the clinical team, with specialist follow‐up if needed
Outcomes Outcomes were evaluated at 3 and 6 months after randomisation
The primary outcome was the carer‐rated *Bristol Activities of Daily Living Scale (BADLS) at 6 months
Secondary outcomes listed in the protocol for the person with dementia were: quality of life (self‐rated Control, Autonomy, Self‐realisation and Pleasure 19‐item, CASP‐19; either self‐rated or care partner Dementia Quality of Life, DEMQOL*; self‐rated Investigating Choice Experiments for the Capability of Older people, ICECAP‐O**), social engagement (self‐rated Lubben Social Network Scale‐Revised, LSNS‐R; self‐rated Practitioner Assessment of Network Type, PANT**), activities of daily living (care partner‐rated Revised Interview for Deterioration in Daily Living Activities in Dementia, R‐IDDD), cognition (Standardised Mini‐Mental State Examination, S‐MMSE; Clinical Dementia Rating scale, CDR)
Outcomes completed by care partners listed in the protocol were: mental health status (self‐rated General Health Questionnaire, GHQ‐12), quality of life (self‐rated ICECAP‐O** and CASP‐19), and sense of competence in caring (self‐rated *Short Sense of Competence Questionnaire, SSCQ)
The study included also economic measures
There were no statistically significant differences detected between the groups at the end of therapy and follow‐up time points. Process evaluation sub‐study indicated appropriate fidelity of the intervention provision.
*Included into the meta‐analysis; **Measure not reported in the main outcome paper or process evaluation paper
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Authors used a computerised system that was managed by a Clinical Trial Unit. Quote: "Allocation between groups used dynamic software to randomise participants in real time, thus preventing subversion while ensuring (stochastic) balance between groups."
Allocation concealment (selection bias) Low risk Quote: "Trial managers coordinated recruitment and forwarded participants’ details to the trials unit’s email‐based randomisation service. After baseline interviews, the unmasked trial data manager oversaw randomisation, which allocated participants in equal proportions between intervention and comparator groups, stratified by Trust or Health Board (1 of 10); time since first attendance at memory clinic (more or less than 90 days); gender (male or female); age (more or less than 75 years); and living with primary carer or not."
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and therapists were not blinded. There was a scope for potential bias in the self‐reported subjective outcomes.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Assessors were blinded. They were also asked to indicate which group they believed the participants was allocated to, at the end of each assessment. Quote: "Including masking status in covariate adjustment did not alter the treatment effect."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Descriptive data for outcome measures were not published in the main outcome paper and were not provided as supplementary data. Data were provided by the authors on request for most measures. Attrition was at 26% level, similar in both groups, and only slightly higher than anticipated.
Selective reporting (reporting bias) High risk Several measures that were included in the protocol and referenced in the trial findings paper did not have any data reported: ICECAP‐O, Practitioner Assessment of Network Type, Resource Utilisation in Dementia; Client Service Receipt Inventory data reported in supplementary materials.
Other bias Low risk There was no evidence for other significant sources of bias.
Training of those delivering the intervention Unclear risk No details provided regarding training for practitioners in relation to intervention provision. Online training was provided with regard to completing outcome measures.  
Intervention manual Low risk A manual for practitioners has been developed and is available online.