Post Stroke FatigueNCT03034590
How to Identify Fatigue in Stroke Patients
An observational study of Post Stroke Fatigue and Stroke, run by Herlev Hospital at 1 site in Denmark.
Trial summary
This study will translate an English case definition of poststroke fatigue and validate it against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke Fatigue, Stroke
- What is being tested?
- questionnaire
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Mar 2015
- 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: stroke patients with a new stroke within 120 days
Who may be able to join
- Patients with a clinical stroke within the last 6 months as judged by a senior doctor or by the research assistant.
- Patients that have given written informed consent
- -
Who cannot join
- Patients with aphasia, dementia or cognitive deficits so severe that they are unable to understand the purpose of the interview and the questionnaire. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How to Identify Fatigue in Stroke Patients: Validity of the Post-stroke Fatigue Case Definition
This study will translate an English case definition of poststroke fatigue and validate it against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale
- Conditions
- Post Stroke Fatigue, Stroke
- Being tested
- questionnaire
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean MFI-20 score for case positive patients
Describes validity of the case definition with regards to the MFI-20 questionnaire
Measured: at inclusion in the trial
Mean FSS-7 score for case positive patients
Describes validity of the case definition with regards to the FSS-7 questionnaire
Measured: At inclusion in the trial
Secondary outcomes (2)
inter rater variability of the case definition
Reinterview by a second interviewer
Measured: within a week
Optimal cut off score for case positiveness on MFI-20 and FSS
decide the optimal cut-off score on the two questionnaires to define case positiveness
Measured: at inclusion in the trial (which is the time the values used are measured)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke FatigueStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karsten Overgaard, Herlev Hospital
- Investigators
- Karsten Overgaard, MD, Principal investigator, Department of Neurology, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034590
- Sponsor's protocol ID
- ID 3-3013-583/1/
- Status last verified
- Jan 2017
- First submitted
- 12 Oct 2016
- Last updated
- 27 Jan 2017
- 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 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Identify Fatigue in Stroke Patients: Validity of the Post-stroke Fatigue Case Definition
- ClinicalTrials.gov ID
- NCT03034590
- Acronym / sponsor ID
- ID 3-3013-583/1/
- Conditions
- Post Stroke Fatigue, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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 will translate an English case definition of poststroke fatigue and validate it against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients with a new stroke within 120 days
Key inclusion criteria (3 listed)
- Patients with a clinical stroke within the last 6 months as judged by a senior doctor or by the research assistant.
- Patients that have given written informed consent
- -
Key exclusion criteria (1 listed)
- Patients with aphasia, dementia or cognitive deficits so severe that they are unable to understand the purpose of the interview and the questionnaire. -
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 |
|---|---|---|
| questionnaire | Other | – |
Primary outcome
Mean MFI-20 score for case positive patients
Time frame: at inclusion in the trial
Describes validity of the case definition with regards to the MFI-20 questionnaire
Mean FSS-7 score for case positive patients
Time frame: At inclusion in the trial
Describes validity of the case definition with regards to the FSS-7 questionnaire
2 secondary outcomes
inter rater variability of the case definition
Time frame: within a week
Optimal cut off score for case positiveness on MFI-20 and FSS
Time frame: at inclusion in the trial (which is the time the values used are measured)
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 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Post Stroke Fatigue
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue
Stroke
Recruiting
Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia
Aphasia Following Cerebral Infarction, Stroke Ischemic
Recruiting
Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
Stroke
RecruitingPhase 2
Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue
Stroke, Stroke, Chronic
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.
Karsten Overgaard, MD principal investigator
Department of Neurology, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Stroke Fatigue and Stroke, run by Herlev Hospital 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 3 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 Jan 2017. 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?
Mean MFI-20 score for case positive patients (time frame: at inclusion in the trial). The study lists 2 primary outcomes in all. 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 Jan 2017.