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

February 11, 2015 updated by: Universidade Nova de Lisboa

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1169-056
        • Faculdade de Ciências Médicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mental Health Problems

Exclusion Criteria:

  • Refusal to enter the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training

Data collected during the first pahse of the study will be presented and discussed in a specialist focus group, which will work with the study team as advisors and trainers, to decide on the type of training to be developed.

This training intervention will be applied to the facilities presenting half the patient sample size.
Behavioral: Training
Adapted training on the patients active participation, rehabilitation, independence, rights and wellbeing.
No Intervention: No Training
Facilities representing half the sample size will not be trained as in the Experimental Arm and continue their standard of care for these patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time spent in any activity during a week by patients
Time Frame: Four months
The percentage of time spent will be measured by the "Time Use Diary" instrument.
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Collaborators

Direção Geral de Saúde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/2012/CEFCM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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