Quality of LifeFITNCT05357625
The Impact of Feedback Informed Treatment in Floating Support Service
A study testing Feedback Informed Treatment in people with Quality of Life, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Feedback Informed Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,162 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2015to 12 Sep 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Citizens who will receive floating support at the municipality of Copenhagen
Who cannot join
- Citizens who refuses to get the support. If the caseworkers do not think the citizen will need further support.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
SFI the Danish National Centre for Social Research
Copenhagen, DK-1052
About this study
Official title: The Impact of Feedback Informed Treatment in Floating Support Service - a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Quality of Life
- Being tested
- Feedback Informed Treatment
- Keywords
- Partners for change outcome management system, Feedback-informed treatment, Routine Outcome management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback Informed TreatmentBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Clients in the treatment group received the usual floating support service as described for the control group together with feedback. The support workers received feedback from the clients through the ORS and SRS scales of the feedback tool (Bargmann and Robinson 2011). The support worker evaluated the progress of the outcome for the client and the alliance between the support worker and the client from session to session. Receives: Behavioral: Feedback Informed Treatment |
| Control group | No intervention | Clients in the control group received the usual floating support service without Feedback. Therefore, there was no systematic feedback between clients and support workers in the control group. The service was provided in the clients' homes, and there was no fixed limit of sessions for the support. The support covered any problem, including setting up tenancies, working with clients around practical things, so they could live independently, making sure that clients received all relevant benefits and helping clients with access to physical and mental health services. Some support workers saw their clients on a weekly basis, but there was a large variation in the frequency of meetings. Furthermore, the duration of the support service varied, from a few weeks to several years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO5 wellbeing scale
The investigators measured the participants wellbeing using the WHO5 wellbeing scale
Measured: 1-15 month after baseline
Secondary outcomes (7)
Drop outs
Number of Drop outs from the floating service
Measured: 1-15 month after baseline
Length of floating support service
The investigators measured treatment duration as the length of the floating support service in the experiment period
Measured: 1-15 month after baseline
Successful support
It floating support service has been successful. Service stopped by caseworker because goal for service reached.
Measured: 1-15 month after baseline
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.
Measured: 1-15 month after baseline
General health
To measure general health, the investigators used a single global item, that has been used in the SF-36 questionnaire
Measured: 1-15 month after baseline
Social relations
Social relations measured by items from WHO100
Measured: 1-15 month after baseline
Physical wellbeing
Physical wellbeing measured with items from WHO100
Measured: 1-15 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 May 2015
- Primary completion12 Sep 2016
- Study completion12 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVE - The Danish Center for Social Science Research
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Municipality, Denmark
- Responsible party
- Sponsor
- Investigators
- Kræn B Jensen, PhD, Study director, VIVE - The Danish Center for Social Science Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357625
- Sponsor's protocol ID
- SFI 2808
- Acronym
- FIT
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2016
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Feedback Informed Treatment in Floating Support Service - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05357625
- Acronym / sponsor ID
- FIT / SFI 2808
- Conditions
- Quality of Life
- Keywords
- Partners for change outcome management system, Feedback-informed treatment, Routine Outcome management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,162 participants (actual)
- Lead sponsor
- VIVE - The Danish Center for Social Science ResearchUniversity, hospital or other
- Collaborators
- Copenhagen Municipality, Denmark
- Study start
- 1 May 2015 (actual)
- Primary completion
- 12 Sep 2016 (actual)
- Study completion
- 12 Sep 2016 (actual)
- First posted
- 3 May 2022 (actual)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Feedback Informed TreatmentClients in the treatment group received the usual floating support service as described for the control group together with feedback. The support workers received feedback from the clients through the ORS and SRS scales of the feedback tool (Bargmann and Robinson 2011). The support worker evaluated the progress of the outcome for the client and the alliance between the support worker and the client from session to session. |
| Control group | No intervention | –Clients in the control group received the usual floating support service without Feedback. Therefore, there was no systematic feedback between clients and support workers in the control group. The service was provided in the clients' homes, and there was no fixed limit of sessions for the support. The support covered any problem, including setting up tenancies, working with clients around practical things, so they could live independently, making sure that clients received all relevant benefits and helping clients with access to physical and mental health services. Some support workers saw their clients on a weekly basis, but there was a large variation in the frequency of meetings. Furthermore, the duration of the support service varied, from a few weeks to several years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Citizens who will receive floating support at the municipality of Copenhagen
Key exclusion criteria (1 listed)
- Citizens who refuses to get the support. If the caseworkers do not think the citizen will need further support.
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 |
|---|---|---|
| Feedback Informed TreatmentFIT 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 | Behavioural | Treatment group |
Primary outcome
WHO5 wellbeing scale
Time frame: 1-15 month after baseline
The investigators measured the participants wellbeing using the WHO5 wellbeing scale
7 secondary outcomes
Drop outs
Time frame: 1-15 month after baseline
Length of floating support service
Time frame: 1-15 month after baseline
Successful support
Time frame: 1-15 month after baseline
Number of eviction cases
Time frame: 1-15 month after baseline
General health
Time frame: 1-15 month after baseline
Social relations
Time frame: 1-15 month after baseline
Physical wellbeing
Time frame: 1-15 month after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Kræn B Jensen, PhD study director
VIVE - The Danish Center for Social Science Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback Informed Treatment in people with Quality of Life, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
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: finished, as of the sponsor's last update on 27 Apr 2023. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WHO5 wellbeing scale (time frame: 1-15 month after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.