Abstract
Background
There is increasing interest in non-pharmacological approaches to address the needs of patients with Alzheimer's disease and other dementia. However, previous research highlighted the need to adapt interventions to the healthcare system.
Objective
To evaluate the effectiveness for community-dwelling patients with mild-to-moderate dementia in France, of maintaining occupational therapy (OT) over a longer period compared with standard OT.
Methods
We used a pragmatic, single-blinded randomized controlled trial (RCT) design (ClinicalTrials.gov NCT03435705). A total of 238 community-dwelling adults with dementia were recruited from OT services and randomly assigned to receive either standard OT (12–15 home-based sessions over a 3–4-month period) or OT maintained for an additional 4 months. The primary outcome was behavioral symptoms measured with the Neuropsychiatric Inventory (NPI) at 8 months. The secondary outcomes included participants’ functional performance, depressive symptoms, quality of life, institutionalization, caregivers’ burden and sense of competence. Primary analysis followed intention-to-treat. Linear model was used to compare changes in NPI scores between groups at 8 months, with imputation for missing values.
Results
In total, 211 participants (88.6%) were assessed for the primary outcome at 8 months. Participants benefiting from OT maintenance showed no significant improvement in behavioral symptoms compared to controls (adjusted mean difference = −3.8, 95% confidence interval: −10.3; 2.7). Maintenance of OT had no effect on secondary outcomes.
Conclusions
Our pragmatic RCT did not support changing the current policy regarding the coverage of the French model of OT. Nevertheless, the non-significant improvement in behavioral symptoms calls for further long-term trials.
Keywords
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