Condition category
Mental and Behavioural Disorders
Date applied
11/04/2013
Date assigned
05/07/2013
Last edited
25/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with severe mental illnesses (SMI) often have a small social network, lack of resources and a small amount of social roles. Although they do have the same goals in life as other people, it is more difficult for them to realize those goals. Rehabilitation methods support people to choose, achieve and maintain desirable social roles. A well-known and often applied rehabilitation method in The Netherlands is the Comprehensive Approach to Rehabilitation (CARe) methodology. The CARe methodology aims to establish a personal-professional relationship in which the care provider joins the needs and desires of the client. The overall goal of the CARe methodology is to improve the client's quality of life. This is done by helping fulfill the wishes of the client, supporting the client and improving the quality of the social environment. This study aims to investigate the effectiveness of the CARe methodology and assess if support of clients by use of the CARe methodology leads to more recovery compared to clients who receive care as usual.

Who can participate?
The study will be executed in three Regional Institutes for Residential Care (RIRCs; Dutch acronym RIBWs). These institutes provide housing services, as supported housing and supported independent living, to people with long-term severe mental diseases. A minimum of 320 clients (120 per group) will be included in this study.

What does the study involve?
The teams in the intervention group will receive the CARe methodology training, schooling and implementation support to care for their clients. The teams in the control group maintain their usual practice.

What are the possible benefits and risks of participating?
Regarding the guidance of the workers (the intervention) there are no risks, the method has been used for several years. Regarding participating in the study, the only strain is filling in the questionnaires (three times, taking about 1.5 hours).

Where is the study run from?
Tilburg University, Tranzo Scientific Center for Care and Welfare

When is the study starting and how long is it expected to run for?
The study started in May 2012. Inclusion of participants started in November 2012. Data gathering will end February 2015. The study will run until the beginning of 2016.

Who is funding the study?
Funding has been provided by five RIRCs using the CARe methodology: Kwintes, RIBW KA/M, RIBW Gooi- en Vechtstreek, RIBW Arnhem en Veluwevallei and RIBW Fonteynenburg and Storm Rehabilitation.

Who is the main contact?
Neis Bitter MSc (PhD student)
n.a.bitter@uvt.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jaap Van Weeghel

ORCID ID

Contact details

Warandelaan 2
Tilburg
5000 LE
Netherlands
-
jweeghel@kcphrenos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OND1351138

Study information

Scientific title

Effectiveness of the Comprehensive Approach to Rehabilitation (CARe) methodology: a randomized controlled trial

Acronym

CAREER

Study hypothesis

Support of clients by use of the CARe methodology leads to more recovery compared to clients who receive care as usual.

Ethics approval

The Medical Research Ethics Committee of Elisabeth Hospital in Tilburg, 11/10/2012, ref: NL41169.008.12

Study design

Two-armed cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Severe and persistant mental illness

Intervention

Intervention group: CARe methodology
Teams in the intervention group receive the CARe methodology training. The aims of this training are: training workers in the principles of rehabilitative and recovery-supportive care and to support clients' rehabilitation process in a methodical way. The central principles are: creating a personal-professional relationship with a client aiming to build a cooperative relationship (presence perspective); to map the strengths of a client and his/her environment; determining goals for the future; and to draw up a personal plan and a supporting plan. The training consists of seven meetings (three theoretical and four methodical work support) and is taught by trainers from a specialized training institute (website RINO groep). To enlarge the implementation level team leaders will also take part in the training. Besides that there will be given special attention to the process of implementation and securing of this.
In practice working with the CARe methodology consists of the following 6 steps: (1) building and maintaining a constructive relationship; (2) collecting information and making a personal profile with the client; (3) helping the client with formulating wishes, making choices and setting goals; (4) helping the client making a Personal Plan; (5) helping the client execute the plan and (6) following the process, learn, evaluate and adjust.
After the training program the workers will be supported in working according to the CARe methodology by means of CARe coaching meetings (once every 4-6 weeks) in which practical cases can be discussed. These coaching meetings are guided by a trained CARe coach from the particular organization independent of the team the workers are working in.

Care as usual
The teams in the intervention group do not receive the CARe methodology basis training. The workers in those teams will maintain to work according to the (narrowly implemented) outdated CARe methodology. Teams in the control group will be asked not to implement new recovery/rehabilitation oriented practices as long as they participate in the study.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Recovery: will be measured by use of the Mental Health Recovery Measure (MHRM). The MRHM is a self-report instrument with 30 items. All items are rated using a five-point Likert scale that ranges from 'strongly disagree' to 'strongly agree'.
2. Social Functioning: the Social Functioning Scale (Birchwood) will be used to measure social functioning. The scale consists of 19 items (with different scales) and 4 checklists with activities.
3. Quality of life: will be assessed by the Manchester Short Appraisal (MANSA). The MANSA consists of 12 items with a seven-point Likert scale ('could not be worse' to 'could not be better').
4. Empowerment: for the measurement of empowerment the Dutch Empowerment Scale will be used. This scale consists of 40 items on a five-point Likert scale ranges from 'strongly disagree' to 'strongly agree'.
5. Hope: will be assessed by the Herth Hope Index, consisting of 12 four-point Likert scale items ranging from 'strongly disagree' to 'strongly agree'.
6. Confidence: the Mental Health Confidence Scale (MHCS) will be used to measure confidence . This scale has 16 items with a six-point Likert scale ('totally no confidence' to 'full confidence').
7. Need for care will be measured by use of The Camberwell Assessment of Needs (CANSAS) consisting of 22 items.
8. Goal achievement: the goals of the participating clients will be registered.

All primary outcome measures will be measured at baseline (T0), after 10 months (T1) and 20 months (T2).

Secondary outcome measures

1. Psychiatric symptoms: will be measured by use of the Brief Symptom Index (BSI), 52 items with a five-point scale from 'not at all' to 'very much'.
2. Relationship between client and worker: the Recovery Promoting Relationship Scale (RPRS) will be used to measure the way the client experiences the relationship with his or her key worker. This measure has 24 items on a four-point Likert scale ranging from 'disagree' to 'agree'
The key workers of the participating clients will be asked to answer questions regarding the diagnosis and care consumption, psychiatric diagnosis (DSM IV) of the client and the amount of contact they have with the client. Besides that, care consumption in general and use of work/recreation facilities will be questioned.
3. Workers' knowledge of recovery will be measured by use of the Recovery Knowledge Inventory (RKI) consisting of 20 items on a five-point Likert scale ranging from 'strongly disagree' to 'strongly agree'.

All secondary outcome measures will be measured at baseline (T0), after 10 months (T1) and 20 months (T2).

Overall trial start date

01/05/2012

Overall trial end date

01/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

All mature clients of the participating organizations who are able to fill in the questionnaires (with help if necessary)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

320

Participant exclusion criteria

1. Age below 18 years
2. No personal/key worker
3. Too little knowledge of the Dutch language to fill in the questionnaire
4. An IQ below 50

Recruitment start date

01/11/2012

Recruitment end date

01/02/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Warandelaan 2
Tilburg
5000 LE
Netherlands

Sponsor information

Organisation

Kwintes (Netherlands)

Sponsor details

PO Box 31
Laan van Vollenhove 3213
Zeist
3700 AA
Netherlands

Sponsor type

Other

Website

http://www.kwintes.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Five Regional Institutes for Residential Care (RIRC): Kwintes, RIBW Fonteynenburg, RIBW KA/M, RIBW Gooi- en Vechtstreek, RIBW Arnhem en Veluwevallie (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Storm Rehabilitation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26198855
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27881159

Publication citations

Additional files

Editorial Notes

25/11/2016: Publication reference added.