- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357625
The Impact of Feedback Informed Treatment in Floating Support Service (FIT)
The Impact of Feedback Informed Treatment in Floating Support Service - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, DK-1052
- SFI the Danish National Centre for Social Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment group
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.
|
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
|
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WHO5 wellbeing scale
Time Frame: 1-15 month after baseline
|
The investigators measured the participants wellbeing using the WHO5 wellbeing scale
|
1-15 month after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drop outs
Time Frame: 1-15 month after baseline
|
Number of Drop outs from the floating service
|
1-15 month after baseline
|
|
Successful support
Time Frame: 1-15 month after baseline
|
It floating support service has been successful.
Service stopped by caseworker because goal for service reached.
|
1-15 month after baseline
|
|
Social relations
Time Frame: 1-15 month after baseline
|
Social relations measured by items from WHO100
|
1-15 month after baseline
|
|
Physical wellbeing
Time Frame: 1-15 month after baseline
|
Physical wellbeing measured with items from WHO100
|
1-15 month after baseline
|
|
Length of floating support service
Time Frame: 1-15 month after baseline
|
The investigators measured treatment duration as the length of the floating support service in the experiment period
|
1-15 month after baseline
|
|
Number of eviction cases
Time Frame: 1-15 month after baseline
|
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
|
|
General health
Time Frame: 1-15 month after baseline
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Kræn B Jensen, PhD, VIVE - The Danish Center for Social Science Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SFI 2808
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Quality of Life
-
Ziekenhuis Oost-LimburgRecruitingQuality of Life | Postoperative Quality of Recovery | Health-Related Quality-of-LifeBelgium
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Istituto Ortopedico RizzoliUniversity of BolognaCompletedImprove Quality of LifeItaly
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway
Clinical Trials on Feedback Informed Treatment
-
University of DundeeUniversity of Strathclyde; Chief Scientist Office of the Scottish Government; Information Services Division, NHS ScotlandCompletedComplications of Surgical and Medical Care: General TermsUnited Kingdom
-
Karolinska InstitutetRecruitingChild Behavior Problem | Substance Use Disorders | Domestic Violence | Family Conflict | Criminal Behavior | Everyday Activities | Housing | Family Communication | Social CareSweden
-
Sara GorczynskiUniversity of Pittsburgh; United States Naval Medical Center, San Diego; Walter... and other collaboratorsActive, not recruiting
-
Baylor College of MedicineU.S. Army Medical Research and Development CommandCompletedBreast NeoplasmsUnited States
-
University of BergamoUniversity of Palermo; University of Sheffield; University of Ottawa; Leiden University and other collaboratorsRecruitingFeedback, PsychologicalItaly
-
Modum BadEnrolling by invitation
-
Second Affiliated Hospital of Wenzhou Medical UniversityNorthwestern UniversityRecruitingUrinary Incontinence, UrgeChina
-
University of MiamiNational Institute on Minority Health and Health Disparities (NIMHD)CompletedDepression | ADHD | Conduct Disorder | Family Dysfunction
-
Norwegian University of Science and TechnologyThe Research Council of Norway; Norwegian Foundation for Health and RehabilitationCompleted
-
University of Notre DameNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingAlcohol Use | Opioid Use Disorder | Alcohol Use Disorder | Opioid UseUnited States