Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer’s disease patients’ quality of life

INTRODUCTION: Therapeutic education is expanding in the management of Alzheimer’s disease (AD) patients. Several studies have revealed a positive impact of therapeutic educational programmes on the caregiver’s burden and/or quality of life. However, to date, no study has evaluated its impact on the quality of life of the AD patient. METHODS: The THERAD study (THerapeutic Education in Alzheimer’s Disease) is a 12-month randomised controlled trial that started in January 2013. This paper describes the study protocol. THERAD plans to enroll 170 dyads (AD patient and caregiver) on the basis of the following criteria: patient at a mild to moderately severe stage of AD, living at home, receiving support from a family caregiver. The main outcome is the patient’s quality of life assessed by the Logsdon QoL-AD scale at 2 months, reported by the caregiver. The study is being led by geriatricians trained in therapeutic education at Toulouse University Hospital in France. To date, 107 caregiver/patient dyads have been recruited. CONCLUSION: This is the first trial designed to assess the specific impact of a therapeutic educational programme on the AD patient’s quality of life. The final results will be available in 2015. TRIAL REGISTRATION: [ClinicalTrials.gov: NCT01796314] Registered 19 February 2013