Leroi 2019.
Study characteristics | ||
Methods | RCT | |
Participants | N = 61 Parkinson's disease dementia (PDD); dementia with Lewy bodies (DLB) according to standard clinical diagnostic criteria Median age (whole sample) 75 (range 55‐90) Community |
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Interventions | Individual cognitive stimulation adapted for Parkinson's disease (delivered by informal carers) (CST‐PD) (N = 31) Treatment‐as‐usual controls (N = 30) |
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Outcomes | Cognition: ACE‐III; Dementia Cognitive Fluctuation Scale Quality of Life: EQ‐5D; Parkinson's Disease Questionnaire‐39 Quality of relationship: Relationship Satisfaction Scale Mood: Hospital Anxiety & Depression Scale; Lille Apathy Rating Scale; Brief Resilience Scale ADL: The Pill Questionnaire (specific ADL task) Interpersonal Reactivity Index Behaviour problems: NPI Caregiver outcomes: Hospital Anxiety & Depression Scales; EQ‐5D; Short Form‐12 Health Survey (SF‐12); Relationship Satisfaction Scale; Dyadic Relationship Scale; Zarit Burden Interview; Relatives Stress Scale; Family Caregiving Role Scale; Brief Resilience Scale |
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Notes | 30 minutes, 2‐3 times a week for 12 weeks Study also included mild cognitive impairment in Parkinson's disease (PD‐MCI); study authors have provided data for PDD and DLB separately for this review. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "an independent arbiter, applied a single‐stratum, blocked randomization to CST‐PD or TAU at a 1:1 level by participant–dyad". |
Allocation concealment (selection bias) | Low risk | Independent process: "A tamper proof process of single‐strata, blocked randomisation will be applied and communicated via telephone and confirmatory email by an independent arbiter" (trial protocol). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Clearly blinded:"'Procedures were in place to conceal the allocation from the independent, blinded outcome raters". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | In the additional data provided by the study authors for e.g. the main cognition outcome (ACE‐III), 10/28 were missing at post‐treatment (cf. 3/28 for the control group). Analyses were for complete case only, so unclear what effect this might have |
Selective reporting (reporting bias) | Low risk | Results for all outcomes were reported. |
Other bias ‐ training and supervision | Low risk | Care partners received training and support to deliver the intervention. |
Other bias ‐ treatment manual | Low risk | Manual developed (from iCST manual, Yates 2014) for the study |