StrokeNCT03635476
Survey of Lifelong Food and Nutrition Assistance (LIFANA) in Stroke Patients and Caregivers
An observational study of Stroke and Relatives, run by Cereneo AG at 1 site in Switzerland.
Trial summary
Many elderly suffer from nutritional problems that can cause (or can be caused by) a number of complications such as weakened immune systems and chronic health conditions (diabetes type 2, high blood pressure, cardiovascular diseases or even osteoporosis). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke, Relatives, Diet Modification
- What is being tested?
- Qualitative interview study
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2018to 1 Mar 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: stroke patients undergoing rehabilitation
Who may be able to join
- stroke patients undergoing rehabilitation
- caregivers of stroke patients
Who cannot join
- Severe aphasia
- Severe cognitive deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey of Lifelong Food and Nutrition Assistance (LIFANA) in Stroke Patients and Caregivers - Cereneo Schweiz AG (Center for Neurology and Rehabilitation)
Many elderly suffer from nutritional problems that can cause (or can be caused by) a number of complications such as weakened immune systems and chronic health conditions (diabetes type 2, high blood pressure, cardiovascular diseases or even osteoporosis).
Through appropriate adjustments in the diets, on the basis of nutritional advice, the burden of established diseases as well as the risks of developing further conditions can be diminished. The goal of our proposed project LIFANA is to develop and evaluate the LIFANA Nutrition Solution to support healthy nutrition.. This may include general preferences, such as culture, taste, and budget, but more importantly automated and personalised nutritional recommendations based on advice provided by professional nutritionists and allergists. This is a national project co-funded by the European Union.
One of the activities of the project is to collect information through a survey with patients. These questions will contribute to creating solutions that can explore the perspectives of patients.
Read the detailed description
Patients will be approached in the clinic by a neurologist and health care professionals. The questionnaire will take place at cereneo. The group will consist of 25 participants and last between 1h. The Survey will be conducted by a clinician who will take notes. Semi-structured discussion guide will be used. With regard to the communication, the moderator will identify factors that will influence communication in a positive or negative way.
The health professionals will perform content analyses on the transcripts; the schema of categories will be oriented towards the research questions, using open questions, directly addressing quiet participants, and handling the discussion guide in a flexible way.
- Conditions
- Stroke, Relatives, Diet Modification
- Being tested
- Qualitative interview study
- Keywords
- Stroke Rehabilitation, Personalized Nutrition, Mobile-Health, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interview studyOther
Also called Survey
The group in question is part of a research program aimed at developing and evaluating the LIFANA Nutrition Solution, a meal planning recommended system, which suggests meals based on the user's personal profile. This may include general preferences, such as culture, taste, and budget, but more importantly automated and personalised nutritional recommendations based on advice provided by professional nutritionists and allergists.
What is being measured
The primary outcome is the main question the study is designed to answer.
User Needs
The primary endpoint of this study is to explore the perspectives of patients through appropriate adjustments of focus group questions on user needs for managing nutritional status
Measured: 1 day/session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Aug 2018
- Primary completion20 Oct 2018
- Study completion1 Mar 2020
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
- Other
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cereneo AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- cereneo Institute for Interdsciplinary Research (cefir)
- Responsible party
- Principal investigator, Krizia Ferrini, Cereneo AG
- Investigators
- Krizia Ferrini, PhD, Principal investigator, cereneo Schweiz AG | center for neurology & rehabilitationDoris Mösinger, MSc, Study chair, cereneo Schweiz AG | center for neurology & rehabilitationLeopold Zizlsperger, MD, Study director, cereneo Schweiz AG | center for neurology & rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635476
- Sponsor's protocol ID
- LIFOCUS
- Status last verified
- Jan 2021
- First submitted
- 14 Aug 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Lifelong Food and Nutrition Assistance (LIFANA) in Stroke Patients and Caregivers - Cereneo Schweiz AG (Center for Neurology and Rehabilitation)
- ClinicalTrials.gov ID
- NCT03635476
- Acronym / sponsor ID
- LIFOCUS
- Conditions
- Stroke, Relatives, Diet Modification
- Keywords
- Stroke Rehabilitation, Personalized Nutrition, Mobile-Health, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cereneo AGIndustry (pharma, biotech, devices)
- Collaborators
- cereneo Institute for Interdsciplinary Research (cefir)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 17 Aug 2018 (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.
Many elderly suffer from nutritional problems that can cause (or can be caused by) a number of complications such as weakened immune systems and chronic health conditions (diabetes type 2, high blood pressure, cardiovascular diseases or even osteoporosis).
Through appropriate adjustments in the diets, on the basis of nutritional advice, the burden of established diseases as well as the risks of developing further conditions can be diminished. The goal of our proposed project LIFANA is to develop and evaluate the LIFANA Nutrition Solution to support healthy nutrition.. This may include general preferences, such as culture, taste, and budget, but more importantly automated and personalised nutritional recommendations based on advice provided by professional nutritionists and allergists. This is a national project co-funded by the European Union.
One of the activities of the project is to collect information through a survey with patients. These questions will contribute to creating solutions that can explore the perspectives of patients.
Detailed description
Patients will be approached in the clinic by a neurologist and health care professionals. The questionnaire will take place at cereneo. The group will consist of 25 participants and last between 1h. The Survey will be conducted by a clinician who will take notes. Semi-structured discussion guide will be used. With regard to the communication, the moderator will identify factors that will influence communication in a positive or negative way.
The health professionals will perform content analyses on the transcripts; the schema of categories will be oriented towards the research questions, using open questions, directly addressing quiet participants, and handling the discussion guide in a flexible way.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- stroke patients undergoing rehabilitation
Key inclusion criteria (2 listed)
- stroke patients undergoing rehabilitation
- caregivers of stroke patients
Key exclusion criteria (2 listed)
- Severe aphasia
- Severe cognitive deficits
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 |
|---|---|---|
| Qualitative interview studyAlso: SurveyThe group in question is part of a research program aimed at developing and evaluating the LIFANA Nutrition Solution, a meal planning recommended system, which suggests meals based on the user's personal profile. This may include general preferences, such as culture, taste, and budget, but more importantly automated and personalised nutritional recommendations based on advice provided by professional nutritionists and allergists. | Other | – |
Primary outcome
User Needs
Time frame: 1 day/session
The primary endpoint of this study is to explore the perspectives of patients through appropriate adjustments of focus group questions on user needs for managing nutritional status
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 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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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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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Krizia Ferrini, PhD principal investigator
cereneo Schweiz AG | center for neurology & rehabilitation
Doris Mösinger, MSc study chair
cereneo Schweiz AG | center for neurology & rehabilitation
Leopold Zizlsperger, MD study director
cereneo Schweiz AG | center for neurology & rehabilitation
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 Stroke and Relatives, run by Cereneo AG at 1 site in Switzerland.
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 2 inclusion and 2 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 2021. 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 Switzerland. 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?
User Needs (time frame: 1 day/session). 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 2021.