StrokeNCT04564820
Strengthening the Interdisciplinary and Inter Sectoral Collaboration in Stroke Rehabilitation Through Application of FIM
An observational study of Stroke and Rehabilitation, run by Neurorehabilitering - Kbh, City of Copenhagen at 2 sites in Denmark.
Trial summary
This study seeks to explore ways to strengthening the interdisciplinary and inter sectoral collaboration in stroke rehabilitation through the application of Functional Independence Measure® (FIM) and common interdisciplinary patient related tasks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Rehabilitation
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 25 Jan 2021to 15 Jan 2022
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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
Study population: Patients with a postal code in the Municipality of Copenhagen, hospitalized with stoke in Bispebjerg Hospital.
Who may be able to join
- Diagnosed with stroke (i61 and i63).
- Hospitalized for stroke rehabilitation in Bispebjerg Hospital.
- Hospitalized in Regional Beds (given to patients with a brain damage of moderate to severe character who receives intensive rehabilitation) within 1 week of arrival at the hospital.
- Living in the Municipality of Copenhagen.
- Consenting to participate.
- Interdisciplinary staff at Bispebjerg Hospital Neurological Rehabilitation Department and Neurorehabilitering Copenhagen.
Show all 12Show fewer
- Participant in the project group experimenting with the FIM
- Consenting to participate.
- Participant observation:
- Interdisciplinary staff at Bispebjerg Hospital Neurological Rehabilitation Department and Neurorehabilitering Copenhagen.
- Participant in FIM team meetings.
- Consenting to participate.
Who cannot join
- Discharged to other facility than Neurorehabilitering Copenhagen.
- Unable to participate in neuro-rehabilitation in more than one week continuously due to e.g. infection.
- Qualitative study participants:
- Interview Study Participants:
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Neurorehabilitering Copenhagen
Copenhagen, Hellerup, 2900
Bispebjerg Hospital
Copenhagen, København NV, 2400
About this study
Official title: Application of the Functional Independence Measure® (FIM) With the Aim of Strengthening the Interdisciplinary and Inter Sectoral Collaboration in Stroke Rehabilitation - a Mixed Methods Multicenter Study
This study seeks to explore ways to strengthening the interdisciplinary and inter sectoral collaboration in stroke rehabilitation through the application of Functional Independence Measure® (FIM) and common interdisciplinary patient related tasks. The study will be evaluated through interviews with staff, participant observation and quantitative patient data.
Read the detailed description
Bispebjerg Hospital is considering implementing the FIM instrument in the Neurological Department. Before decisions making a more thorough examination is needed to see if the extra resources used to apply the FIM measurement is offset by improvement in the clinic. At Neurorehabilitering Copenhagen FIM measurement has recently been implemented in a trial period of 2 years hence an exploration of the application of FIM is needed.
The study seeks to explore experiences with application of the FIM instrument combined with structured interdisciplinary tasks related to the patient's everyday routines.
Aims:
- To explore behavior, reaction and experiences in multidisciplinary staff members when applying the FIM instrument combined with interdisciplinary collaboration related to common patient tasks. Including:
- the exploration of practical settings.
- the staffs experiences both pros and cons with the application of the FIM instrument.
- the staffs experiences of the interdisciplinary and inter sectoral collaboration.
- To nuance the findings in the qualitative part of the study with quantitative data from the FIM including data on change in FIM score on the short term (2-3 weeks) and long term (approx. 4 months).
- To evaluate on practicalities when applying the FIM instrument including the feasibility of scoring within 72 hours within admittance to and before discharge from the departments and the change in score between the 2 sectors.
- To compare FIM to baseline characteristics such as National Institutes of Health Stroke Scale (NIHSS), Functional oral intake Scale (FOIS), and Pre-Stroke Modified Rankin Score.
Hypotheses:
- It is expected that the application of the FIM instrument combined with interdisciplinary tasks will contribute to a development of a common language between the interdisciplinary staff members and to stimulate a more holistic goalsetting when engaging with the patient. Hereby it is expected to contribute to the interdisciplinary collaboration. A more multidisciplinary approach is expected to be experienced by the application of FIM hereby probably giving less attention to their professional background and more focus on the patient. It is expected that the staff will experience that FIM contributes to a more united use of language between the sectors and hereby linking the whole process of the patient.
- It is expected that the patients will have a moderate to severe disability measured by FIM and a change in score is expected in both sectors.
- Approx. half of the scores are expected to be within the 72 hours of planned timing.
- A moderate correlation is expected between the FIM score and baseline measurements as National Institutes of Health Stroke Scale (NIHSS), Functional oral intake Scale (FOIS) and weak to moderate with Pre-Stroke Modified Rankin Score.
This Mixed Methods Multicenter Study consists of 5 elements divided into a quantitative and a qualitative part. The quantitative part is an observational cohort study with 15-20 stroke patients consecutively recruited. The qualitative part includes 8 participant observations, 4 focus group interviews, approx. 10 individual interviews and data on goalsetting from hospital charts from the 15-20 patients.
The setting is at the Neurological Ward at Bispebjerg Hospital in the Capital Region of Denmark and at Neurorehabilitering Copenhagen, a center which specializes in neurological rehabilitation in the Municipality of Copenhagen.
In the qualitative study, staff in a project group experimenting with the use of the FIM instrument combined with interdisciplinary tasks will participate in focus group interviews and some of them will participate in individual interviews using strategic sampling with maximal variation on profession, years of experience and sector. Participant observation of the FIM scorings will be performed as videorecordings beeing analysed. All qualitative data will be analysed with both investigator and data triangulation.
- Conditions
- Stroke, Rehabilitation
- Keywords
- Stroke, Rehabilitation, Interdisciplinary, Functional Independence Measure, FIM
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure® (FIM)
FIM® measures disability by the amount of assistance needed during daily activities. FIM consists of 18 items, 13 in the motor and 5 in the cognitive domain. The scale ranges from 18-126.
Measured: Admittance to hospital to discharge from a facility in the municipality, approx. 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start25 Jan 2021
- Primary completion1 Nov 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Neurorehabilitering - Kbh, City of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Copenhagen: The University Hospitals Centre for Health Research
- Responsible party
- Principal investigator, Jon Damsager Lauesen, Neurorehabilitering - Kbh, City of Copenhagen
- Investigators
- Irene Conradsen, Master, Principal investigator, Neurorehabilitering Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564820
- Sponsor's protocol ID
- 20-4000
- Status last verified
- Jan 2022
- First submitted
- 21 Sep 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Functional Independence Measure® (FIM) With the Aim of Strengthening the Interdisciplinary and Inter Sectoral Collaboration in Stroke Rehabilitation - a Mixed Methods Multicenter Study
- ClinicalTrials.gov ID
- NCT04564820
- Acronym / sponsor ID
- 20-4000
- Conditions
- Stroke, Rehabilitation
- Keywords
- Stroke, Rehabilitation, Interdisciplinary, Functional Independence Measure, FIM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Neurorehabilitering - Kbh, City of CopenhagenUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Copenhagen: The University Hospitals Centre for Health Research
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 25 Sep 2020 (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.
This study seeks to explore ways to strengthening the interdisciplinary and inter sectoral collaboration in stroke rehabilitation through the application of Functional Independence Measure® (FIM) and common interdisciplinary patient related tasks. The study will be evaluated through interviews with staff, participant observation and quantitative patient data.
Detailed description
Bispebjerg Hospital is considering implementing the FIM instrument in the Neurological Department. Before decisions making a more thorough examination is needed to see if the extra resources used to apply the FIM measurement is offset by improvement in the clinic. At Neurorehabilitering Copenhagen FIM measurement has recently been implemented in a trial period of 2 years hence an exploration of the application of FIM is needed.
The study seeks to explore experiences with application of the FIM instrument combined with structured interdisciplinary tasks related to the patient's everyday routines.
Aims:
- To explore behavior, reaction and experiences in multidisciplinary staff members when applying the FIM instrument combined with interdisciplinary collaboration related to common patient tasks. Including:
- the exploration of practical settings.
- the staffs experiences both pros and cons with the application of the FIM instrument.
- the staffs experiences of the interdisciplinary and inter sectoral collaboration.
- To nuance the findings in the qualitative part of the study with quantitative data from the FIM including data on change in FIM score on the short term (2-3 weeks) and long term (approx. 4 months).
- To evaluate on practicalities when applying the FIM instrument including the feasibility of scoring within 72 hours within admittance to and before discharge from the departments and the change in score between the 2 sectors.
- To compare FIM to baseline characteristics such as National Institutes of Health Stroke Scale (NIHSS), Functional oral intake Scale (FOIS), and Pre-Stroke Modified Rankin Score.
Hypotheses:
- It is expected that the application of the FIM instrument combined with interdisciplinary tasks will contribute to a development of a common language between the interdisciplinary staff members and to stimulate a more holistic goalsetting when engaging with the patient. Hereby it is expected to contribute to the interdisciplinary collaboration. A more multidisciplinary approach is expected to be experienced by the application of FIM hereby probably giving less attention to their professional background and more focus on the patient. It is expected that the staff will experience that FIM contributes to a more united use of language between the sectors and hereby linking the whole process of the patient.
- It is expected that the patients will have a moderate to severe disability measured by FIM and a change in score is expected in both sectors.
- Approx. half of the scores are expected to be within the 72 hours of planned timing.
- A moderate correlation is expected between the FIM score and baseline measurements as National Institutes of Health Stroke Scale (NIHSS), Functional oral intake Scale (FOIS) and weak to moderate with Pre-Stroke Modified Rankin Score.
This Mixed Methods Multicenter Study consists of 5 elements divided into a quantitative and a qualitative part. The quantitative part is an observational cohort study with 15-20 stroke patients consecutively recruited. The qualitative part includes 8 participant observations, 4 focus group interviews, approx. 10 individual interviews and data on goalsetting from hospital charts from the 15-20 patients.
The setting is at the Neurological Ward at Bispebjerg Hospital in the Capital Region of Denmark and at Neurorehabilitering Copenhagen, a center which specializes in neurological rehabilitation in the Municipality of Copenhagen.
In the qualitative study, staff in a project group experimenting with the use of the FIM instrument combined with interdisciplinary tasks will participate in focus group interviews and some of them will participate in individual interviews using strategic sampling with maximal variation on profession, years of experience and sector. Participant observation of the FIM scorings will be performed as videorecordings beeing analysed. All qualitative data will be analysed with both investigator and data triangulation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a postal code in the Municipality of Copenhagen, hospitalized with stoke in Bispebjerg Hospital.
Key inclusion criteria (12 listed)
- Diagnosed with stroke (i61 and i63).
- Hospitalized for stroke rehabilitation in Bispebjerg Hospital.
- Hospitalized in Regional Beds (given to patients with a brain damage of moderate to severe character who receives intensive rehabilitation) within 1 week of arrival at the hospital.
- Living in the Municipality of Copenhagen.
- Consenting to participate.
Key exclusion criteria (4 listed)
- Discharged to other facility than Neurorehabilitering Copenhagen.
- Unable to participate in neuro-rehabilitation in more than one week continuously due to e.g. infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Independence Measure® (FIM)
Time frame: Admittance to hospital to discharge from a facility in the municipality, approx. 4 months.
FIM® measures disability by the amount of assistance needed during daily activities. FIM consists of 18 items, 13 in the motor and 5 in the cognitive domain. The scale ranges from 18-126.
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 8 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Irene Conradsen, Master principal investigator
Neurorehabilitering Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Rehabilitation, run by Neurorehabilitering - Kbh, City of Copenhagen at 2 sites 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 12 inclusion and 4 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Functional Independence Measure® (FIM) (time frame: Admittance to hospital to discharge from a facility in the municipality, approx. 4 months.). 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 8 Feb 2022.