FrailtyFOCUS-WMUNCT03194412
FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input
A study testing Diet /nutritional, Physical activity and Comprehensive therapy in people with Frailty, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
This intervention study is a part of the FOCUS (Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input) project which purpose is to critically reduce the burden of frailty in Europe by assisting those partners within the European Innovation Partnership for Active Healthy… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Diet /nutritional, Physical activity and Comprehensive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePoland
- Study dates
- 19 May 2017to Dec 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients:
- age ≥ 60 years old
- recognition of the pre-frail and frail (based on the scale of the Cardiovascular Health Study)
- consent to participate in the study
- the patients who could speaking Polish language
- caregivers:
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- to be formal or informal caregivers of person aged ≥ 60 years old
- consent to participate in the study
- caregivers who could speaking Polish language
Who cannot join
- patients:
- age < 60 years old
- lack of recognition of the pre-frail and frail (based on the scale of the Cardiovascular Health Study)
- somatic state which precludes complete examination performance according to selected scales (eg. Vision disorders)
- severe mental disorders or difficulties that prevent active participation in the study
- the patients who could not speaking Polish language
Show all 11Show fewer
- lack of consent to participate in the study
- caregivers:
- not to be formal or informal caregivers of person aged ≥ 60 years old
- lack of consent to participate in the study
- the caregivers who could not speaking Polish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)
This intervention study is a part of the FOCUS (Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input) project which purpose is to critically reduce the burden of frailty in Europe by assisting those partners within the European Innovation Partnership for Active Healthy Ageing (EIPAHA) with commitments focusing on early diagnosis/ screening and/or management of frailty to achieve scalability.
FOCUS aims to critically reduce the burden of frailty in Europe by developing methodologies and tools to assist entities focusing on early diagnosis, screening and management of frailty to achieve scalability. Frailty is a common clinical syndrome in older adults that brings an increased risk for poor health outcomes including falls, incident disability, hospitalization and mortality.
Read more
The FOCUS Consortium brings together a multidisciplinary team of specialists from 10 organizations in 6 countries - Italy, Poland, Portugal, Spain, Netherlands, United Kingdom - that will work on developing, piloting and disseminating methodologies and tools to assist entities focusing on early diagnosis, screening and management of frailty to achieve scalability.
Wroclaw Medical University actively participates in all projects for the advances in science, entrepreneurship, technological innovation, both with public authorities, local governments, and enterprises. In FOCUS project, WMU is responsible for Evaluation of the project and collaborates with the others partners in Coordination of the project, Dissemination of the project, Synthesis of learning and realities of practice, Analysis and guidelines development, Creation of Network and Platform for knowledge exchange, Test of guidelines in a set of commitments (Work Package 7 - WP7).
The outcomes of this proposal will offer significant potential improvements for innovative, coordinated and comprehensive community based prevention with regard to the optimisation of functional capacity tools to address pre-frailty, and for improving the management of frailty.
The registered study has its own protocol developed by Wroclaw Medical University research team and will be implemented within WP7 of the FOCUS project.
Read the detailed description
This is a prospective intervention study. The study is expected screening about 320 participants - persons aged more than 60 years old recruited from Universities of the Third Age, day care centers, primary care centers, geriatrics out-patient clinics and from nursing homes. We are expected to enroll 270 potential participants (at least 135 participants) to 5 groups: 4 intervention groups and 1 control group without any intervention.
Patient qualification is based on criteria developed by Fried et al 2001.
Dimensions:
Weight loss Exhaustion Physical Activity Walk Time Grip Strength
INTERPRETATION:
Robust: 0 points Pre-frail: 1-2 points Frail: 3 or more points
Method: diagnostic survey Technique: the 'surveys combined with direct measurements of patients investigated within 0, after 3 and 6 months
Tools:
Study questionnaires:
- Standardized questionnaires: Center for Epidemiologic Studies Depression Scale Minnesota Leisure Time Physical Activity Questionnaire Vulnerable Elders - 13 Survey Mini Nutritional Assessment Health Behaviour Inventory Montreal Cognitive Assessment Geriatric Depression Scale World Health Organization Quality of Life (short version) questionnaire Camberwell Assessment of Need Short Appraisal Schedule Barthel Scale Activities of Daily Living Instrumental Activities of Daily Living Camberwell Assessment of Need Short Appraisal Schedule Timed up and go test Beck Depression Inventory
- The questionnaire on: socio-demographic data - age, gender, marital status, living in relationship/ without relationship, level of education, place of residence, economic status; the number of hospitalizations in the last 3 years (including kind of ward); the number and kind of chronic diseases (ICD-10); the number of permanent medications; employment situation; number of traveling in the last year; having pets; number of languages the participants can speak; number of falls
- Rating of patients' difficulties in the implementation of the intervention (Did the patients perform the interventions? How often? Was it difficult to the patients?)
- Observations sheet: height, weight, BMI, hand grip strength, circumference of arm muscle, circumference of calf
- The results of laboratory tests: sodium , albumins, lymphocytes, LDL cholesterol, C reactive proteins, glomerular filtration rate, fasting glucose, thyroid hormones
- Conditions
- Frailty
- Being tested
- Diet /nutritional, Physical activity, Comprehensive therapy, Caregivers of elderly
- Keywords
- Frail Elderly, Geriatric Assessment, Humans, Aged
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet /nutritionalDietary supplement
- Duration:
- the first stage - 3 months: 12 weeks
- second stage - 3 months: 12 weeks
Each patient collect a detailed menu of the last two days before making the description. Then the menu is analyzed by a nutrition consultant. The role of nutrition consultant is:
- make a diet modification to include the products recommended in frailty
- modifying eating habits
The diet modification is mainly focused on adequate supply:
- vitamin D (according to Central Europe guidelines -2013 for seniors)
- protein (according to European Society for Clinical Nutrition and Metabolism (ESPEN recommendations)
Physical activityBehavioural
Also called regular physical activity in everyday life of the elderly
- Duration:
- the first stage - 3 months: 12 weeks
- second stage - 3 months: 12 weeks
- Frequency: twice a week
- Duration of each session: 60 minutes
Worksheets for the elderly with frailty syndrome have been developed:
- resistance exercises and strength training, which aim to improve muscle strength in the limbs
- exercises aimed at improving motor coordination, flexibility and speed
- stretching exercises.
Comprehensive therapyCombination product
Also called diet/nutritional and physical activity training
Combination of special diet for elderly (as in Group 1) and regular physical activity into everyday life of the elderly (as in Group 2)
Duration:
- the first stage - 3 months- 12 weeks
- the second stage - 3 months- 12 weeks Frequency of physical activity: twice a week Duration of each session: 60 minutes
Caregivers of elderlyBehavioural
Group: formal and informal caregivers of elderly with frailty syndrome Materials and Tools: multimedia presentation about frailty prevention and treatment (nutrition, physical activity, dietary supplement diet).
Duration:
- the first stage - 3 months: 12 weeks
- the second stage - 3 months: 12 weeks
Frequency: 1 (at the beginning of stage 0, 1 and 2) Duration: 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Diet /nutritional | Experimental | Special diet for elderly. It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients. Receives: Dietary Supplement: Diet /nutritional |
| Physical activity | Experimental | Regular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises. Receives: Behavioral: Physical activity |
| Comprehensive therapy | Experimental | Special diet for elderly (appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients) and regular physical activity in everyday life of the elderly (exercises to improve coordination and balance, stretching exercises, strength exercises) Receives: Combination Product: Comprehensive therapy |
| Caregivers of elderly | Experimental | Education about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet). Receives: Behavioral: Caregivers of elderly |
| Control group | No intervention | Without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status change
People who improved/worsened functional status according to standardized measures
Measured: 6 months
Secondary outcomes (4)
Falls change
People who had at least one fall during the period of the intervention
Measured: 6 months
Mood change
People who improved/worsened mood status according to standardized measures
Measured: 6 months
Nutritional status change
People who improved /worsened nutritional status according to standardized measures
Measured: 6 months
Cognitive status change
People who improved /worsened cognitive status according to standardized measures
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start19 May 2017
- Primary completion30 Sep 2017
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- The group of participants involved to the study: * n=60 ( at least 30) to diet /nutritional - intervention group 1 * n=60 ( at least 30) to physical activity - intervention group 2 * n=60 ( at least 30) to comprehensive therapy (diet/nutritional+physical activity training) - intervention group 3 * n=30 (at least 15) formal and informal caregivers of elderly - intervention group 4 * n=60 ( at least 30) to control group without intervention - group 5 Evaluation process: * Screening Evaluation (stage 1)- investigated within 0 * Baseline Evaluation (stage 2) - after 3 months from 0 * Final Evaluation (stage 3) - after 6 months from 0 Professionals involved in the interventions: physicians, general practitioners, physiotherapists, rehabilitation professionals, educators, nurses, volunteers, nutrition consultant.
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia, Roessingh Research and Development, Aston Research Centre for Healthy Ageing (ARCHA), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Di Ricerche Farmacologiche Mario Negri, Nursing School of Coimbra (ESEnfC), Aveiro University, EVERIS, Advanced Software Studies And Maintenance Of Technology
- Responsible party
- Principal investigator, Donata Kurpas, Wroclaw Medical University
- Investigators
- Aneta Soll, MSc, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194412
- Sponsor's protocol ID
- 664367/FOCUS
- Other IDs
- 664367/FOCUS
- Acronym
- FOCUS-WMU
- Status last verified
- Oct 2017
- First submitted
- 17 Jun 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antonio Cano, Donata Kurpas, Maria Magdalena Bujnowska-Fedak, Silvina Santana, Carol Holland, Maura Marcucci, Ana Gonzalez- Segura, Miriam Vollenbroek-Hutten, Barbara D'Avanzo, Alessandro Nobili, João Luís Al ves Apostolo, Elżbieta Bobrowicz-Campos, Ana M. Martínez-Arroyo. FOCUS: Frailty Management Optimisation through EIPAHA Commitments and Utilisation of Stakeholders' Input - an innovative European Project in elderly care. Family Medicine & Primary Care Review 2016; 18, 3: 373-376 DOI: https://doi.org/10.5114/fmpcr/63234
Piotrowicz J, Soll A, Kielar U, Zwiefka A, Guligowska A, Pigłowska M, Kostka T, Kurpas D. ICT and environmental support for patients with frailty syndrome: CareWell Project, Focus Project and SUNFRAIL Project. Medical Science Pulse 2017; 11, 1: 37-43.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOCUS- Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input (WP7-WMU)
- ClinicalTrials.gov ID
- NCT03194412
- Acronym / sponsor ID
- FOCUS-WMU / 664367/FOCUS
- Conditions
- Frailty
- Keywords
- Frail Elderly, Geriatric Assessment, Humans, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- University of Valencia, Roessingh Research and Development, Aston Research Centre for Healthy Ageing (ARCHA), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Di Ricerche Farmacologiche Mario Negri, Nursing School of Coimbra (ESEnfC), Aveiro University, EVERIS, Advanced Software Studies And Maintenance Of Technology
- Study start
- 19 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Jun 2017 (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 intervention study is a part of the FOCUS (Frailty Management Optimization Through EIP AHA Commitments and Utilization of Stakeholders Input) project which purpose is to critically reduce the burden of frailty in Europe by assisting those partners within the European Innovation Partnership for Active Healthy Ageing (EIPAHA) with commitments focusing on early diagnosis/ screening and/or management of frailty to achieve scalability.
FOCUS aims to critically reduce the burden of frailty in Europe by developing methodologies and tools to assist entities focusing on early diagnosis, screening and management of frailty to achieve scalability. Frailty is a common clinical syndrome in older adults that brings an increased risk for poor health outcomes including falls, incident disability, hospitalization and mortality.
The FOCUS Consortium brings together a multidisciplinary team of specialists from 10 organizations in 6 countries - Italy, Poland, Portugal, Spain, Netherlands, United Kingdom - that will work on developing, piloting and disseminating methodologies and tools to assist entities focusing on early diagnosis, screening and management of frailty to achieve scalability.
Wroclaw Medical University actively participates in all projects for the advances in science, entrepreneurship, technological innovation, both with public authorities, local governments, and enterprises. In FOCUS project, WMU is responsible for Evaluation of the project and collaborates with the others partners in Coordination of the project, Dissemination of the project, Synthesis of learning and realities of practice, Analysis and guidelines development, Creation of Network and Platform for knowledge exchange, Test of guidelines in a set of commitments (Work Package 7 - WP7).
The outcomes of this proposal will offer significant potential improvements for innovative, coordinated and comprehensive community based prevention with regard to the optimisation of functional capacity tools to address pre-frailty, and for improving the management of frailty.
The registered study has its own protocol developed by Wroclaw Medical University research team and will be implemented within WP7 of the FOCUS project.
Detailed description
This is a prospective intervention study. The study is expected screening about 320 participants - persons aged more than 60 years old recruited from Universities of the Third Age, day care centers, primary care centers, geriatrics out-patient clinics and from nursing homes. We are expected to enroll 270 potential participants (at least 135 participants) to 5 groups: 4 intervention groups and 1 control group without any intervention.
Patient qualification is based on criteria developed by Fried et al 2001.
Dimensions:
Weight loss Exhaustion Physical Activity Walk Time Grip Strength
INTERPRETATION:
Robust: 0 points Pre-frail: 1-2 points Frail: 3 or more points
Method: diagnostic survey Technique: the 'surveys combined with direct measurements of patients investigated within 0, after 3 and 6 months
Tools:
Study questionnaires:
- Standardized questionnaires: Center for Epidemiologic Studies Depression Scale Minnesota Leisure Time Physical Activity Questionnaire Vulnerable Elders - 13 Survey Mini Nutritional Assessment Health Behaviour Inventory Montreal Cognitive Assessment Geriatric Depression Scale World Health Organization Quality of Life (short version) questionnaire Camberwell Assessment of Need Short Appraisal Schedule Barthel Scale Activities of Daily Living Instrumental Activities of Daily Living Camberwell Assessment of Need Short Appraisal Schedule Timed up and go test Beck Depression Inventory
- The questionnaire on: socio-demographic data - age, gender, marital status, living in relationship/ without relationship, level of education, place of residence, economic status; the number of hospitalizations in the last 3 years (including kind of ward); the number and kind of chronic diseases (ICD-10); the number of permanent medications; employment situation; number of traveling in the last year; having pets; number of languages the participants can speak; number of falls
- Rating of patients' difficulties in the implementation of the intervention (Did the patients perform the interventions? How often? Was it difficult to the patients?)
- Observations sheet: height, weight, BMI, hand grip strength, circumference of arm muscle, circumference of calf
- The results of laboratory tests: sodium , albumins, lymphocytes, LDL cholesterol, C reactive proteins, glomerular filtration rate, fasting glucose, thyroid hormones
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The group of participants involved to the study: * n=60 ( at least 30) to diet /nutritional - intervention group 1 * n=60 ( at least 30) to physical activity - intervention group 2 * n=60 ( at least 30) to comprehensive therapy (diet/nutritional+physical activity training) - intervention group 3 * n=30 (at least 15) formal and informal caregivers of elderly - intervention group 4 * n=60 ( at least 30) to control group without intervention - group 5 Evaluation process: * Screening Evaluation (stage 1)- investigated within 0 * Baseline Evaluation (stage 2) - after 3 months from 0 * Final Evaluation (stage 3) - after 6 months from 0 Professionals involved in the interventions: physicians, general practitioners, physiotherapists, rehabilitation professionals, educators, nurses, volunteers, nutrition consultant.
| Arm | Type | Receives |
|---|---|---|
| Diet /nutritional | Experimental | Dietary Supplement: Diet /nutritionalSpecial diet for elderly. It should be rich in the appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients. |
| Physical activity | Experimental | Behavioral: Physical activityRegular physical activity in everyday life of the elderly - exercises to improve coordination and balance, stretching exercises, strength exercises. |
| Comprehensive therapy | Experimental | Combination Product: Comprehensive therapySpecial diet for elderly (appropriately amount of protein, carotenoids, vitamins, minerals, macro and micronutrients) and regular physical activity in everyday life of the elderly (exercises to improve coordination and balance, stretching exercises, strength exercises) |
| Caregivers of elderly | Experimental | Behavioral: Caregivers of elderlyEducation about frailty: prevention and treatment (nutrition, physical activity, dietary supplement diet). |
| Control group | No intervention | –Without intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patients:
- caregivers:
Key exclusion criteria (11 listed)
- patients:
- caregivers:
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 |
|---|---|---|
| Diet /nutritional• Duration: * the first stage - 3 months: 12 weeks * second stage - 3 months: 12 weeks Each patient collect a detailed menu of the last two days before making the description. Then the menu is analyzed by a nutrition consultant. The role of nutrition consultant is: * make a diet modification to include the products recommended in frailty * modifying eating habits The diet modification is mainly focused on adequate supply: * vitamin D (according to Central Europe guidelines -2013 for seniors) * protein (according to European Society for Clinical Nutrition and Metabolism (ESPEN recommendations) | Dietary supplement | Diet /nutritional |
| Physical activityAlso: regular physical activity in everyday life of the elderly* Duration: * the first stage - 3 months: 12 weeks * second stage - 3 months: 12 weeks * Frequency: twice a week * Duration of each session: 60 minutes Worksheets for the elderly with frailty syndrome have been developed: * resistance exercises and strength training, which aim to improve muscle strength in the limbs * exercises aimed at improving motor coordination, flexibility and speed * stretching exercises. | Behavioural | Physical activity |
| Comprehensive therapyAlso: diet/nutritional and physical activity trainingCombination of special diet for elderly (as in Group 1) and regular physical activity into everyday life of the elderly (as in Group 2) Duration: * the first stage - 3 months- 12 weeks * the second stage - 3 months- 12 weeks Frequency of physical activity: twice a week Duration of each session: 60 minutes | Combination product | Comprehensive therapy |
| Caregivers of elderlyGroup: formal and informal caregivers of elderly with frailty syndrome Materials and Tools: multimedia presentation about frailty prevention and treatment (nutrition, physical activity, dietary supplement diet). Duration: * the first stage - 3 months: 12 weeks * the second stage - 3 months: 12 weeks Frequency: 1 (at the beginning of stage 0, 1 and 2) Duration: 60 minutes | Behavioural | Caregivers of elderly |
Primary outcome
Functional status change
Time frame: 6 months
People who improved/worsened functional status according to standardized measures
4 secondary outcomes
Falls change
Time frame: 6 months
Mood change
Time frame: 6 months
Nutritional status change
Time frame: 6 months
Cognitive status change
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- BackgroundAntonio Cano, Donata Kurpas, Maria Magdalena Bujnowska-Fedak, Silvina Santana, Carol Holland, Maura Marcucci, Ana Gonzalez- Segura, Miriam Vollenbroek-Hutten, Barbara D'Avanzo, Alessandro Nobili, João Luís Al ves Apostolo, Elżbieta Bobrowicz-Campos, Ana M. Martínez-Arroyo. FOCUS: Frailty Management Optimisation through EIPAHA Commitments and Utilisation of Stakeholders' Input - an innovative European Project in elderly care. Family Medicine & Primary Care Review 2016; 18, 3: 373-376 DOI: https://doi.org/10.5114/fmpcr/63234
- BackgroundPiotrowicz J, Soll A, Kielar U, Zwiefka A, Guligowska A, Pigłowska M, Kostka T, Kurpas D. ICT and environmental support for patients with frailty syndrome: CareWell Project, Focus Project and SUNFRAIL Project. Medical Science Pulse 2017; 11, 1: 37-43.
- Family Medicine \& Primary Care ReviewLink provided by the sponsor.
- Medical Science PulseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Aneta Soll, MSc principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet /nutritional, Physical activity and Comprehensive therapy in people with Frailty, run by Wroclaw Medical University at 1 site in Poland.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Nov 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 Poland. 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?
Results are not available in the source record.
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 status change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194412, which also lists 2 linked publications.
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 1 Nov 2017.