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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05357625
Other study ID # SFI 2808
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date September 12, 2016

Study information

Verified date July 2016
Source VIVE - The Danish Center for Social Science Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Feedback Informed Treatment (FIT) is a systematic feedback method. FIT is based on two simple questionnaires and aims to assess and improve the effectiveness of therapeutic treatment. Treatment outcomes are assessed with the Outcome Rating Scale (ORS), a four-item self-report instrument measuring client functioning in the area of quality of life. Therapeutic alliance is assessed using the four-item Session Rating Scale (SRS). In FIT the feedback from the client is used to continuous adjustment and improvement of therapy. SFI will study the effect of using feedback in social work with floated support in the municipality of Copenhagen. Floating Support is a service that provides housing related support to vulnerable citizens to enable them to maintain their independence in their own home. The project is based on three different types of floating support. The aim of floating support is to improve the citizen's mental, physical and social well-being and thereby makes it more likely that the citizen can live independently at home. The study is a randomized controlled trial in which half of the caseworkers are allocated to be trained in the use of FIT, while the other half serves as a control group and will continue to work as usual. SFI is studying whether FIT can help to improve the impact of the floating support service on the citizen's mental, physical and social well-being and the citizens' likelihood of living in their own homes.


Description:

The study was designed as a cluster randomized controlled trial, where the investigators randomized 65 support workers to a treatment group (that used FIT) or a control group (that did not use FIT) at the beginning of the experiment. The investigators used block randomization within each unit to ensure that the number of support workers was evenly distributed between the treatment and control groups within each organizational unit. The investigators generated the random sequence using SAS. When a support worker resigned during the experiment, another support worker with the same allocation took over the resigned worker's clients. If a new support worker was employed during the experiment in a unit with an even number of workers, the support worker was randomized to either the treatment group or the control group by simple randomization. If the unit had an uneven number of support workers, the new support worker was allocated to a group that ensured the unit kept the same uneven number of treatment and control workers. The study included clients who had already begun in the support service before the experiment started and clients that started in the support service during the experiment. If a support worker only had one or two contacts with a new client, the client was not included in the study. The study period was 16 months and ended when FIT was implemented in the control group.


Recruitment information / eligibility

Status Completed
Enrollment 1162
Est. completion date September 12, 2016
Est. primary completion date September 12, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Citizens who will receive floating support at the municipality of Copenhagen Exclusion Criteria: - Citizens who refuses to get the support. If the caseworkers do not think the citizen will need further support.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Feedback Informed Treatment
FIT is based on two simple questionnaires and aims to assess and improve the effectiveness of therapeutic treatment. Treatment outcomes are assessed with the Outcome Rating Scale (ORS), a four-item self-report instrument measuring client functioning in the area of quality of life. Therapeutic alliance is assessed using the four-item Session Rating Scale (SRS). In FIT the feedback from the client is used to continuous adjustment and improvement of therapy

Locations

Country Name City State
Denmark SFI the Danish National Centre for Social Research Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
VIVE - The Danish Center for Social Science Research Copenhagen Municipality, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary WHO5 wellbeing scale The investigators measured the participants wellbeing using the WHO5 wellbeing scale 1-15 month after baseline
Secondary Drop outs Number of Drop outs from the floating service 1-15 month after baseline
Secondary Length of floating support service The investigators measured treatment duration as the length of the floating support service in the experiment period 1-15 month after baseline
Secondary Successful support It floating support service has been successful. Service stopped by caseworker because goal for service reached. 1-15 month after baseline
Secondary Number of eviction cases As a measure of possible eviction, the investigators used the mandatory notification sent to the municipality when a citizen living in the public housing sector is subject to an eviction case sent to the Danish bailiff's court. 1-15 month after baseline
Secondary General health To measure general health, the investigators used a single global item, that has been used in the SF-36 questionnaire 1-15 month after baseline
Secondary Social relations Social relations measured by items from WHO100 1-15 month after baseline
Secondary Physical wellbeing Physical wellbeing measured with items from WHO100 1-15 month after baseline
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