Evaluation of the Effectiveness of the World Health Organization QualityRights Training in Italy
NCT Number: NCT06484205
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caregiver Burden
Interventions: OTHER: WHO QualityRights e-training|OTHER: Emotional intelligence e-training
Sponsor: University of Cagliari
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-26
Completion Date: 2025-12-06
Locations: Azienda Ospedaliero Universitaria Cagliari, Cagliari, 09100, Italy

Summary:
The research aims to promote human rights of people with psychosocial disabilities. The design will be a randomized controlled trial (RCT) with two groups. The intervention will consist of participation in an online training, with a central focus on the human rights of people with psychosocial disabilities. The measured outcomes will be knowledge of human rights, caregivers' attitudes towards people with psychosocial disabilities as rights holders, caregiver burden, depressive symptoms, and quality of life.

Primary Outcome Measures: Improving the knowledge about human rights and the attitudes of caregivers towards people with psychosocial disabilities, To evaluate it will be used: the World Health Organization's Knowledge about the Rights of persons with psychosocial disabilities questionnaire (16 items). It was developed by World Health Organization (WHO) to assess knowledge about the rights included in the United Nations Convention on the Rights of Persons with Disabilities (UN CRPD), and The World Health Organization's questionnaire on the attitudes towards people with psychosocial disabilities as rights-holders (17 items). It was developed by WHO and includes three sub-scales: attitudes towards institutionalization and living independently in the community; attitudes toward mandatory treatment and coercion; attitudes toward people with psychosocial disabilities as decision-makers., T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)
Secondary Outcome Measures: Change from Baseline to post intervention and to follow-ups of The Short Form Health Survey (Quality of life), To evaluate it will be used: The Short Form Health Survey (SF-12), a brief version of SF-36 questionnaire, made up of twelve questions, values range from 12 to 47, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health assessed on a monthly basis . Higher scores recorded a greeting and better Quality of life, T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)|Change from Baseline to post intervention and to follow-ups of Patient Health Questionnaire-9 (Depressive symptoms), To evaluate it will be used: Patient Health Questionnaire-9 (PHQ-9) a short self-administered tool, values range from 0 to 27, used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to Diagnostic and statistical manual of mental disorders (DSM-IV) on last two weeks. Higher scores identify a greater presence of depressive symptoms., T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)|Change from Baseline to post intervention and to follow-ups of Zarit Burden interview, To evaluate it will be used: The Zarit Burden interview, a questionnaire for assessing the consequences that the care burden of a family member with chronic disabilities has on the caregiver. It is a self-assessment tool made up of 22 items with responses rated on a 5-point Likert scale: from 0 (never) to 4 (almost always) based on the degree of agreement with the individual items. The items investigate how the patient's disability impacts the caregiver's quality of life, psychological suffering, sense of guilt, financial difficulties, shame and social and family difficulties., T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)