Study protocol: a cluster randomized controlled trial to assess the effectiveness of a therapeutic educational...

Schizophrenia is a severe mental disorder that affects 1 % of the world's population, including 600,000 people in France. Persons with schizophrenia (PWS) have excess mortality (their life expectancy is reduced by 20 %) and excess morbidity. In addition, such persons may have a large number of missing or decayed teeth. Dental caries and periodontal measurement indexes are often twice as high as the level found in the general population. Poor oral health can also affect quality of life and oral health is inseparable from general health. The management of oral health problems needs a multidisciplinary approach. According to the World Health Organization, the aim of therapeutic education (TE) is to help patients take care of themselves and to improve empowerment and recovery. In this educational approach, it is important to take into account the patient's personal experience. Though rarely investigated, the personal experience of PWS in oral health quality of life (OHRQoL) must be used to build a therapeutic educational programme in oral health (TEPOH) in a multidisciplinary approach, and the effectiveness of this program must be evaluated.

We report the protocol of a randomized controlled cluster study. This study will be conducted in twelve hospitals in France. We hypothesized that a decrease of 20 % in the proportion of patients with CPI ≥ 3 would establish the effectiveness of TEPOH. Therefore, 12 hospitals will be randomly allocated to either TEPOH or no TEPOH. Altogether, they will have to recruit 230 PWS, who will be randomly allocated with a ratio of 1:1 to one of two conditions: control without intervention versus the group benefitting from TEPOH.

If successful, the study will generate methodologically sound results that provide knowledge on the effectiveness of a TEP in oral health for PWS. The results can be used to promote OHRQoL in a global health approach and develop appropriate strategies to encourage and facilitate financial support for healthcare, the multidisciplinary treatment of dental disorders, and the development of training in oral and mental health for caregivers. Trial registration Clinical Trials Gov NCT02512367. Date registered 19 July, 2015.