Rehabilitation and Quality of Life in Residential Units for People With Longer Term Mental Health Problems

Schizophrenia Clinical Trial

Official title:

Rehabilitation and Quality of Life in Residential Units for People With Longer Term Mental Health Problems

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02366117
• Other study ID #: 02/2012/CEFCM
• Status: Active, not recruiting
• Phase: N/A
• First received: February 9, 2015
• Last updated: February 11, 2015
• Start date: April 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Universidade Nova de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IPPortugal: Data Protection Agency
• Study type: Interventional

Clinical Trial Summary

The study design is that of a cluster randomised controlled trial

The aims of the study were: 1) to assess the quality of care of the residential units for people with long-term mental disorders; 2) to design a training intervention for the staff of the units in the intervention group; 3) to assess the effectiveness of the intervention 4 and 8 months after it ended.

The main outcome variable was level of activity of the users. Secondary outcome variables were the QuIRC dimensions.

The selection of the sample was by residential units for people with long-term mental disorders.

The inclusion criteria were all the middle and high-support residential units in Portugal. Units that had only one type of service users (e.g., mental retardation, dementia) were excluded.

The quality of care of the units was assessed with the QuIRC filled on line by the managers of the units and validated with Service Users Interview Schedule, a face-to-face interview with the users (users that could not give informed consent or collaborate in the interview were excluded).

Description:

The development of community services for treating and rehabilitating people with longer term mental disease, including residential units, is a priority throughout Europe. Recent outcome studies have demonstrated encouraging results in rehabilitation program for most people with schizophrenia, event those with high needs.

Recent legislation in Portugal and the approval of the first Mental Health Plan provided a thrust for developing community services for severe mental patients, specially those directed to patients with schizophrenia or schizoaffective disorders.

The recent National Program for Ongoing Care in Mental Health is a unique opportunity to develop even more residential units and highlights the urgent need to evaluate these facilities.

There are no published studies on the quality of these services, nor the impact that teatment and rehabilitation programs may have on the abilities and negative symptoms of their inpatients because, until recently, their were no reliable instruments for this.

The DEMoB.inc (Development of a European Measure of Best Practice for People with Long Term Mental Illness in Institutional Care) study, a multicentric study financed by the European Comission, between 2007-2010, changed this situation. Its primary goal was the development of a a new instrument for evaluating the quality of the care provided and the quality of life in psychiatric residential units and the social sector. Our team was the portuguese partner for the study.

The final version of the instrument now called QuIRC (Quality Indiciator in Rehabilitative Care) is available in portuguese on www.quirc.com. Several articles on this study have been published.

This set of circumstances opens a unique opportunity:

• The creation of more residential units for longer term mental patients.

• The existence of an instrument designed and developed for assessing these facilities.

The urgent need for assessing the quality of care provided in the facilities and the efectivity of their interventions is the primary goal of this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mental Health Problems

Exclusion Criteria:

• Refusal to enter the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mental Disease
• Mental Disorders
• Schizophrenia

Intervention

Behavioral:
• Training
Adapted training on the patients active participation, rehabilitation, independence, rights and wellbeing.

Locations

Country	Name	City	State
Portugal	Faculdade de Ciências Médicas	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Direção Geral de Saúde

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time spent in any activity during a week by patients	The percentage of time spent will be measured by the "Time Use Diary" instrument.	Four months	No