Impact of an educational programme on Alzheimer’s disease patients’ quality of life: results of the randomized controlled trial THERAD

BACKGROUND: Although educational interventions are recommended in Alzheimer’s disease (AD), studies assessing the impact of interventions such as “therapeutic patient education” are scarce. Indeed, the intrinsic nature of the disease is considered a barrier to patients’ involvement in such approaches. We aimed to evaluate an intervention by using a “dyadic” approach (patient and caregiver) in both intervention and assessment. METHODS: THERAD is a monocentric, randomized, controlled trial assessing the effects of a 2-month educational programme in mild to moderately severe AD patients among 98 dyads (caregiver/patient) on caregiver-reported patient quality of life (QOL) at 2 months. Community-dwelling patients and their caregivers were recruited in ambulatory units of the French Toulouse University Hospital. Self-reported patient QOL, autonomy, behavioural and psychological symptoms and caregiver QOL and burden were collected at 2, 6 and 12 months. Linear mixed models were used in modified intention-to-treat populations. We also performed sensitivity analysis. RESULTS: A total of 196 dyads were included, 98 in each group. The mean age of the patients was 82 years, 67.7% were women, diagnosed with AD (+/- cerebrovascular component) (mean MMSE =17.6), and 56.9% lived with a partner. The mean age of the caregivers was 65.7 years, and 64.6% were women (52.3% offspring/42.6% spouses), with a moderate burden (mean Zarit score = 30.9). The mean caregiver-reported patient QOL was lower than the self-reported QOL (28.61 vs. 33.96). We did not identify any significant difference in caregiver-reported patients’ QOL (p = 0.297) at 2 months, but there was a significant difference in self-reported patients’ QOL at 2 months (p = 0.0483) or 6 months (p = 0.0154). No significant difference was found for the secondary outcomes. The results were stable in the sensitivity analyses. CONCLUSIONS: This randomized controlled trial assessing an educational intervention in 196 dyads (Alzheimer’s disease affected patient/caregiver) highlights the need to better consider the patient’s point of view, since only the self-reported QOL was improved. Additional studies using this dyadic approach are necessary in targeted subpopulations of caregivers (spouse vs. child, gender) and of patients (severity of cognitive impairment or behavioural disturbances) TRIAL REGISTRATION: THERAD study NCT01796314. Registered on February 19, 2013.