SchizophreniaNCT02366117
Rehabilitation and Quality of Life in Residential Units for People With Longer Term Mental Health Problems
A study testing Training in people with Schizophrenia and Mental Disease, run by Universidade Nova de Lisboa at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Mental Disease
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePortugal
- Study dates
- Apr 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mental Health Problems
Who cannot join
- Refusal to enter the study
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Ciências Médicas
Lisbon, Lisbon District, 1169-056
About this study
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.
Read more
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).
Read the 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.
- Conditions
- Schizophrenia, Mental Disease
- Being tested
- Training
- Keywords
- Quirc, Quality Indiciator in Rehabilitative Care
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Adapted training on the patients active participation, rehabilitation, independence, rights and wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | 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. Receives: Behavioral: Training |
| No Training | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startApr 2012
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Direção Geral de Saúde
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366117
- Sponsor's protocol ID
- 02/2012/CEFCM
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cardoso G, Papoila A, Tome G, Killaspy H, King M, Caldas-de-Almeida JM. A cluster randomised controlled trial of a staff-training intervention in residential units for people with long-term mental illness in Portugal: the PromQual trial. Soc Psychiatry Psychiatr Epidemiol. 2017 Nov;52(11):1435-1445. doi: 10.1007/s00127-017-1416-7. Epub 2017 Jun 30.
PubMed 28667486
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation and Quality of Life in Residential Units for People With Longer Term Mental Health Problems
- ClinicalTrials.gov ID
- NCT02366117
- Acronym / sponsor ID
- 02/2012/CEFCM
- Conditions
- Schizophrenia, Mental Disease
- Keywords
- Quirc, Quality Indiciator in Rehabilitative Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Direção Geral de Saúde
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: TrainingData 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. |
| No Training | No intervention | –Facilities representing half the sample size will not be trained as in the Experimental Arm and continue their standard of care for these patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mental Health Problems
Key exclusion criteria (1 listed)
- Refusal to enter the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingAdapted training on the patients active participation, rehabilitation, independence, rights and wellbeing. | Behavioural | Training |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Derived from this study: PubMed 28667486Cardoso G, Papoila A, Tome G, Killaspy H, King M, Caldas-de-Almeida JM. A cluster randomised controlled trial of a staff-training intervention in residential units for people with long-term mental illness in Portugal: the PromQual trial. Soc Psychiatry Psychiatr Epidemiol. 2017 Nov;52(11):1435-1445. doi: 10.1007/s00127-017-1416-7. Epub 2017 Jun 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Schizophrenia and Mental Disease, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time spent in any activity during a week by patients (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02366117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.