Factors predictive of adherence to a non-pharmacological intervention in nursing home research: a substudy of the LEDEN trial

Abstract

Few older people participate in medical research, especially in the nursing home setting. The lack of evidence in this population may limit our ability to provide evidence-based treatments. This can partly be explained by difficulties in obtaining a satisfactory adherence to research in this population, especially when the practice of a physical activity is needed. In this study data from the LEDEN trial (Effects of a Long-term Exercise Program on Functional Ability in People with Dementia Living in Nursing Homes: A Cluster Randomized Controlled Trial) was used to determine the predictors of adherence to the study protocol. Retrospective cohort study based on the data from the cluster randomized, controlled LEDEN trial. The LEDEN trial aimed to compare the effects of an exercise intervention with a nonphysical intervention on the ability to perform activities of daily living. Predictors of adherence (being present at ≥ 75% of sessions of the LEDEN trial) were identified by multivariable logistic regression. By univariate analysis, the EVIBE scale (EValuation Immédiate du Bien-Être – evaluation of instantaneous well-being) measured at baseline was associated with study adherence, whereby higher scores were associated with higher adherence: 16.7% (1/6), 44.4% (4/9), 56.5% (13/23), 48.1% (13/27) and 75.0% (15/20) respectively for EVIBE scores from 1 to 5 (P = 0.02 for trend). By multi-variable analysis, an EVIBE scale score ≥ 4 did not predict clinical trial adherence (odds ratio [OR] 1.554, 95% confidence interval [CI] 0.619–3.942). Adherence was found to be lower among persons aged ≥ 95 years (OR: 0.121, 95%CI: 0.006–0.982). Older age (≥ 95 years) was associated with lower adherence to the study protocol. Further studies are needed to better understand and anticipate obstacles to adherence in research, while respecting consent procedures and patient autonomy.