Study design, setting, and participants
A pre-post prospective study was conducted. This study adheres to the CONSORT guidelines. Participants were consecutively recruited in November 2016. They were recruited from a community in Fukuoka, the 5th largest city of Japan. The inclusion criteria were being a primary family caregiver for a patient clinically diagnosed with dementia and residing with the patient. The monthly 2-hour training programme was held three times in Fukuoka from December 2016 to Feb 2017. After each training session, the participants received weekly postcards over three months containing information about the methodology, for a total of 12 postcards.
Prior to the training, the participants completed the Japanese short version of the Zarit Burden Interview (J-ZBI) to assess caregiver burden [16, 17]. They also completed the Behavioral Pathology in Alzheimer’s Disease (Behave-AD) to evaluate behavioural and psychological symptoms in the people with dementia for whom they provided care [18, 19]. A monthly 2-hour multimodal comprehensive care methodology training programme was provided three times, which was followed by weekly delivery of information via a total of 12 postcards. One month and three months after the training, secondary surveys were conducted to obtain the post-intervention J-ZBI scores of the participants and the post-intervention Behave-AD scores of the people with dementia (Figure 1).
The ZBI is one of the most widely used measures of caregiver burden and assesses the impact of caregiving on caregivers, including physical, mental, social and economic aspects . In this study, the short version of the J-ZBI, which has been linguistically validated, was used . This questionnaire is an 8-item instrument that has been widely used and validated among caregivers. It uses a 5-point Likert scale anchored by “strongly disagree” and “strongly agree” (range: 0-32). The participants completed the J-ZBI. The scale was administered before the training (pre-training), one month later, and three months later (post-training).
The Behave-AD is the most widely used instrument for the evaluation of dementia-related behavioural changes based on informant interviews . The questionnaire is a 26-item instrument that has been widely used and validated among caregivers and uses a 4-point scale. It addresses delusions, hallucinations, activity disturbances, aggressiveness, diurnal rhythm disturbances, affective disturbances, anxieties and phobias. The people with dementia were assessed using the Japanese version of the Behave-AD, which has been linguistically validated . The assessor of each patient was his or her participating family caregiver; the Behave-AD was completed prior to the study and one month and three months after the intervention.
The primary outcome was the difference in the J-ZBI scores from before the training (pre-training) to three months later (post-training). The secondary outcome was the difference in the Behave-AD scores between pre-training and post-training.
Multimodal comprehensive care methodology training programme
As the intervention, we implemented a French multimodal comprehensive care methodology training programme. In 1979, Gineste and Marescotti developed a multimodal comprehensive care methodology called the HumanitudeTM [14, 15]. HumanitudeTM refers to the set of particularities that allow us to feel that we are members of the human species and to recognize other human beings as members of the same species. They defined this recognition as established by using what they called the 4 pillars: gaze, talk, touch, and vertical body. They developed this care methodology based on the considerations of dignity, freedom and autonomy in the daily care provided to dependent and vulnerable persons. The methodology focuses on 4 elements of communication with patients: gaze, talk, touch, and assistance with standing up. Additionally, all care is provided in a sequence consisting of 5 stages: 1) Notification (Pre-preliminaries), 2) Preparation (Preliminaries), 3) Integration of communication (Sensory circle), 4) Emotional consolidation (Emotional consolidation), and 5) Next appointment (Appointment). The aim of Notification (Stage 1) is to announce the presence of the caregiver, avoid surprise approaches and respect the patient’s privacy and autonomy. Preparation (Stage 2) represents the initial establishment of a relationship through the relationship pillars (gaze, speech and touch), and it allows the caregiver to obtain consent for the relationship from the person receiving the care. Integration of communication (Stage 3) includes the provision of care with a consistent positive emotional environment between the caregiver and the patient. At the end of the care, Emotional consolidation (Stage 4) is a stage of cognitive and mental stimulation that leaves a positive impression of the relationship and care in the emotional memory of the person receiving it, facilitating consent to the relationship and the acceptance of future care. Next appointment (Stage 5) is the final moment of the relationship, in which commitment to future care is affirmed because the emotional memory is functioning even if they have advanced dementia. At this stage, goodbyes are said, and a new meeting is scheduled, which prevents a feeling of abandonment . The programme administered in the current study consisted of training participants in skills that could be used at home using this multimodal comprehensive care methodology. The training was performed by a certified instructor. The instructor provided lectures, demonstrations and role-play workshops to teach the participants how to adapt the methodology to people with dementia. After each monthly training programme, we sent weekly postcards with information about the methodology as “a goal for this week” to the participants for three months.
The normality of all data was verified by the Shapiro-Wilk test. A Wilcoxon signed rank test was used to test for significant differences between the pre-training and post-training J-ZBI scores and Behave-AD scores. The paired-samples t-test was used to test for significant differences in the categories of the J-ZBI scores. The baseline characteristics of the people with dementia were compared using the Fisher’s exact test for categorical variables and the Mann-Whitney U test for continuous variables. These analyses were performed using R statistical software (version 3.5.3). Statistical significance was defined when P < 0.05.