StrokeINFRANCT02856009
Role of Nutrition in Patients Over 75 Years of Age With Stroke
A study testing completion of a quality of life questionnaire in people with Stroke, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis. Patients older than 75 years also show excess mortality. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- completion of a quality of life questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Dec 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with symptomatic stroke defined according to WHO criteria (including cerebral infarction and intracerebral haemorrhage) managed at the stroke ICU, Neurology 1, Neurology 2, Internal Medicine 2 or Geriatrics at Dijon CHU during the period from 1st November 2015 to 30th September 2016.
- Patients aged 75 years and older.
- Patients who have provided informed consent to take part in the study.
Who cannot join
- Patients with meningeal haemorrhage or TIA.
- Patients who refuse to take part in the study.
- Patients with hypo-albuminemia not related to malnutrition: chronic infectious or inflammatory syndrome, nephrotic syndrome, exudative enteropathy, hydration disorders.
- Subjects in custody.
- Patients (or person of trust) who cannot be contacted by telephone during the follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Nutritional Status and Frailty on the Prognosis of Patients Over 75 Years Old Who Suffered a Stroke
Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis. Patients older than 75 years also show excess mortality. One of the hypotheses to explain this situation is the high level of frailty in this population. Many tools to measure the concept of frailty have been developed. One important dimension of these tools is the nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent situation, is also a complex phenomenon.
The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects older than 75 years hospitalized in Dijon CHU.
- Conditions
- Stroke
- Being tested
- completion of a quality of life questionnaire
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of a quality of life questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | Not described Receives: Other: completion of a quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2016
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.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856009
- Sponsor's protocol ID
- Béjot 2015
- Acronym
- INFRA
- Status last verified
- Jul 2016
- First submitted
- 2 Aug 2016
- Last updated
- 10 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Status and Frailty on the Prognosis of Patients Over 75 Years Old Who Suffered a Stroke
- ClinicalTrials.gov ID
- NCT02856009
- Acronym / sponsor ID
- INFRA / Béjot 2015
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Aug 2016 (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.
Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis. Patients older than 75 years also show excess mortality. One of the hypotheses to explain this situation is the high level of frailty in this population. Many tools to measure the concept of frailty have been developed. One important dimension of these tools is the nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent situation, is also a complex phenomenon.
The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects older than 75 years hospitalized in Dijon CHU.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Other: completion of a quality of life questionnaire |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients with symptomatic stroke defined according to WHO criteria (including cerebral infarction and intracerebral haemorrhage) managed at the stroke ICU, Neurology 1, Neurology 2, Internal Medicine 2 or Geriatrics at Dijon CHU during the period from 1st November 2015 to 30th September 2016.
- Patients aged 75 years and older.
- Patients who have provided informed consent to take part in the study.
Key exclusion criteria (5 listed)
- Patients with meningeal haemorrhage or TIA.
- Patients who refuse to take part in the study.
- Patients with hypo-albuminemia not related to malnutrition: chronic infectious or inflammatory syndrome, nephrotic syndrome, exudative enteropathy, hydration disorders.
- Subjects in custody.
- Patients (or person of trust) who cannot be contacted by telephone during the follow-up.
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 |
|---|---|---|
| completion of a quality of life questionnaire | Other | patient |
Primary outcome
Mortality rate
Time frame: Day 28
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 10 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing completion of a quality of life questionnaire in people with Stroke, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 5 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 10 Oct 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 France. 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?
Mortality rate (time frame: Day 28). 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 10 Oct 2017.