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

Abstract

BackgroundGroup cognitive stimulation therapy programmes can benefit cognition and quality of life for people with dementia. Evidence for home-based, carer-led cognitive stimulation interventions is limited.ObjectivesTo evaluate the clinical effectiveness and cost-effectiveness of carer-delivered individual cognitive stimulation therapy (iCST) for people with dementia and their family carers, compared with treatment as usual (TAU).DesignA multicentre, single-blind, randomised controlled trial assessing clinical effectiveness and cost-effectiveness. Assessments were at baseline, 13 weeks and 26 weeks (primary end point).SettingParticipants were recruited through Memory Clinics and Community Mental Health Teams for older people.ParticipantsA total of 356 caregiving dyads were recruited and 273 completed the trial.InterventioniCST consisted of structured cognitive stimulation sessions for people with dementia, completed up to three times weekly over 25 weeks. Family carers were supported to deliver the sessions at home.Main outcome measuresPrimary outcomes for the person with dementia were cognition and quality of life. Secondary outcomes included behavioural and psychological symptoms, activities of daily living, depressive symptoms and relationship quality. The primary outcome for the family carers was mental/physical health (Short Form questionnaire-12 items). Health-related quality of life (European Quality of Life-5 Dimensions), mood symptoms, resilience and relationship quality comprised the secondary outcomes. Costs were estimated from health and social care and societal perspectives.ResultsThere were no differences in any of the primary outcomes for people with dementia between intervention and TAU [cognition: mean difference –0.55, 95% confidence interval (CI) –2.00 to 0.90;p-value = 0.45; self-reported quality of life: mean difference –0.02, 95% CI –1.22 to 0.82;p-value = 0.97 at the 6-month follow-up]. iCST did not improve mental/physical health for carers. People with dementia in the iCST group experienced better relationship quality with their carer, but there was no evidence that iCST improved their activities of daily living, depression or behavioural and psychological symptoms. iCST seemed to improve health-related quality of life for carers but did not benefit carers’ resilience or their relationship quality with their relative. Carers conducting more sessions had fewer depressive symptoms. Qualitative data suggested that people with dementia and their carers experienced better communication owing to iCST. Adjusted mean costs were not significantly different between the groups. From the societal perspective, both health gains and cost savings were observed.ConclusionsiCST did not improve cognition or quality of life for people with dementia, or carers’ physical and mental health. Costs of the intervention were offset by some reductions in social care and other services. Although there was some evidence of improvement in terms of the caregiving relationship and carers’ health-related quality of life, iCST does not appear to deliver clinical benefits for cognition and quality of life for people with dementia. Most people received fewer than the recommended number of iCST sessions. Further research is needed to ascertain the clinical effectiveness of carer-led cognitive stimulation interventions for people with dementia.Trial registrationCurrent Controlled Trials ISRCTN65945963.FundingThis project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 64. See the NIHR Journals Library website for further information.

Communication training interventions for family and professional carers of people living with dementia: a systematic review of effectiveness, acceptability and conceptual basis

“…Overall methodological quality was variable across all quantitative studies and only four studies had low bias ratings in three or more domains (Chenoweth et al, 2014;De Rotrou et al, 2011;Livingston et al, 2013;Orgeta et al, 2015). See Table 2 for the overall assessment of risk of bias.…”

“…Performance bias was present in all of the quantitative studies due to the impossibility of blinding patients and trainers to the intervention being delivered. However, most studies were also subject to detection bias; only seven studies used comprehensive assessor blinding (Ballard et al, 2016;Broughton et al, 2011;Chenoweth et al, 2014;De Rotrou et al, 2011;Gitlin, Winter, & Dennis, 2010;Livingston et al, 2013;Orgeta et al, 2015).…”

“…Eight studies reported adequate randomisation processes and allocation procedures, and therefore reduced selection bias (Ballard et al, 2016;Chenoweth et al, 2014;De Rotrou et al, 2011;Gitlin et al, 2010;Livingston et al, 2013;Orgeta et al, 2015;Prick, De Lange, Twisk, & Pot, 2015;van der Ploeg et al, 2013). However, attrition levels were often high and rarely reported for each treatment group.…”

“…However, attrition levels were often high and rarely reported for each treatment group. Only four studies provided sufficient information to conclude that attrition was sufficiently equal across groups (Cristancho-Lacroix et al, 2015;De Rotrou et al, 2011;Orgeta et al, 2015;Prick et al, 2015) (in addition, one small scale dissertation reported no attrition) (Gentry, 2011). Four studies were clearly protocol driven and provided enough information to conclude a low risk of reporting bias (Chenoweth et al, 2014;CristanchoLacroix et al, 2015;Livingston et al, 2013;Orgeta et al, 2015).…”

“…Only four studies provided sufficient information to conclude that attrition was sufficiently equal across groups (Cristancho-Lacroix et al, 2015;De Rotrou et al, 2011;Orgeta et al, 2015;Prick et al, 2015) (in addition, one small scale dissertation reported no attrition) (Gentry, 2011). Four studies were clearly protocol driven and provided enough information to conclude a low risk of reporting bias (Chenoweth et al, 2014;CristanchoLacroix et al, 2015;Livingston et al, 2013;Orgeta et al, 2015). Ten studies reported small sample sizes (Alnes, Kirkevold, & Skovdahl, 2011;Beer, Hutchinson, & Skala-Cordes, 2012;Cristancho-Lacroix et al, 2015;Cruz, Marques, Barbosa, Figueiredo, & Sousa, 2011;Gentry, 2011;Haberstroh et al, 2011;Liddle et al, 2012;Prick et al, 2015;Raglio et al, 2016;van der Ploeg et al, 2013).…”