Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05070286
Status:
UNKNOWN
Last Update Posted:
2022-01-21
First Post:
2021-05-11
Brief Title:
Lifestyle Weight Management Program Interviews and Stakeholder Meetings
Sponsor:
Oxford Brookes University
Organization:
Oxford Brookes University
Study Overview
Official Title:
A Lifestyle Weight Management Program for Paediatric Patients With Demyelinating Conditions Interviews and Stakeholder Meetings
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background An assessment by paediatric neurologists specializing in demyelinating conditions brought attention to the rapid weight change seen among patients recently diagnosed with and receiving therapy for neuromyelitis optica spectrum disorder NMOSD and multiple sclerosis MS An overview of the current literature pinpointed weight change as a concern and identified fatigue and fear as limiting factors for participation in physical activity with BMI trajectories in this population significantly higher compared to healthy peers A look at current patient data highlighted extreme NMOSD cases where some patients weight doubled in two years There is currently no available research that addresses weight change and management in paediatric MS or NMOSD patients but there is research to highlight the importance of maintaining health behaviours The aim of this research is to co-develop a comprehensive lifestyle weight management program for this cohort
Methods Unpinned by the Medical Research Council guidance for developing complex interventions this research will involve a fourfold approach It will build on a previously completed systematic review and a secondary data analysis of current clinical data regarding weight changes in these populations Semi-structured interviews will be conducted with patients parents and clinicians in order to obtain qualitative data regarding the collective perspectives of nutrition weight change and overall health A list of factors will be identified and presented in a logic model A program will then be designed informed by previously gathered information and will be reviewed by a group of stakeholders via stakeholder meetings This will output a program design implementation and evaluation plan which will then be evaluated for feasibility Recruitment participation implementation and adherence to the program will be tested A patient public involvement PPI approach will be taken with a PPI panel of experts overseeing and guiding the project for its duration
Results The results of this research will output a primary version of the lifestyle weight management program for paediatric patients with demyelinating conditions ready for a feasibility trial
Methods Unpinned by the Medical Research Council guidance for developing complex interventions this research will involve a fourfold approach It will build on a previously completed systematic review and a secondary data analysis of current clinical data regarding weight changes in these populations Semi-structured interviews will be conducted with patients parents and clinicians in order to obtain qualitative data regarding the collective perspectives of nutrition weight change and overall health A list of factors will be identified and presented in a logic model A program will then be designed informed by previously gathered information and will be reviewed by a group of stakeholders via stakeholder meetings This will output a program design implementation and evaluation plan which will then be evaluated for feasibility Recruitment participation implementation and adherence to the program will be tested A patient public involvement PPI approach will be taken with a PPI panel of experts overseeing and guiding the project for its duration
Results The results of this research will output a primary version of the lifestyle weight management program for paediatric patients with demyelinating conditions ready for a feasibility trial
Detailed Description:
RESEARCH QUESTIONS AND AIMS
Aim
To co-develop a comprehensive lifestyle weight management program catered specifically for paediatric patients with demyelinating conditions such as multiple sclerosis MS and neuromyelitis optica spectrum disorder NMOSD
Objectives
1 To explore perspectives and perceptions regarding weight change health and quality of life through semi-structured interviews of young people with MS and NMOSD their parents and clinicians
2 To establish a list of factors that contribute to weight change in the paediatric MS and NMOSD patients following steroid treatment mapped out in a logic model
3 To co-design a lifestyle weight management program for paediatric MS and NMOSD patients through the compilation of information and data obtained and the input from stakeholder meetings
Outcome
The final outcome of this study will be a lifestyle weight management program that is ready for a feasibility trial It will output a set of end-user requirements as well as a fully formed underpinning logic model
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS
Method overview
Building on a previously completed scoping review and an audit of the research teams pre-existing patient data and information from the collaborating institutions this stage of the research involves three distinct phases
Phase 1 Foundational co-development- Interviews
Phase 2 Logic model of factors
Phase 3 Program design and implementation plan- Stakeholder Meetings
Phase 1 Interviews Young people with MS or NMOSD their familiescarers and health care professionals HCPs will participate in interviews to gain perspectives and perceptions with regards to weight change in order to develop a suitable intervention for implementation in the care pathway
Design
Participatory design with semi-structured interviews
Objectives
Describe the factors affecting the management of these conditions with regards to quality of life health and wellbeing
Identify potential modifiablenon-modifiable factors that contribute to weight change in this population
Highlight and extract important concerns and themes and explore the barriers and facilitators to implementing a lifestyle management system for this population within the care pathway
Participants
15 young people aged 10-25 with MS or NMOSD Including MOG
15 parentscarers
15 health care practitioners from medical nursing and AHP backgrounds with at least two years experience in NMOSD and MS
N 45
Method
Semi-structured interviews underpinned by a thematic analysis with patients parents and clinicians The questions will be focused around predetermined themes and factors extracted from the previously performed scoping review and data audit and involving nutrition weight changes overall health and quality of life The team psychologist will co-develop questions related to behaviour and The nutritionist and exercise specialist will co-develop in their respective fields The PPI members will co-develop all interview formats and methods There will be three different versions of the questions one for patients one for parents and one for clinicians The interview questions will remain consistent throughout the study
Procedure
Interviews with parents patients and HCPs will be performed virtually via video call using the secured Google Hangouts platform Invitations to join the link will be sent via email and events will be made private
The participants will have the option to participate while at home or at one of the three research sites during one of their clinical appointment days It is foreseen that patients and their parents will participate virtually from their home however should they need assistance or accommodation this will be provided by one of our three research sites In this case the clinical nurse will assist with the virtual interview when the patient is present at one of the hospitals for their bi-yearly day of clinical appointments Clinicians will also be given the option to either participate virtually from home or from one of the research sites The interviewer will perform the interview from a private room at Oxford Brookes University Parents will be interviewed on their own whereas patients will be interviewed with their parent present- if under 16 Patients aged 16 years may have their parents present should they wish but the parent will be asked not to contribute The estimated interview time is 45- 60 mins subject to change during the development process There will be a brief post interview questionnaire where the participants will be given the opportunity to mention anything they might not have been able to discuss in the interview It will also allow for the research team to collect data with regards to the execution of the research and to consequently assess the chosen methods
Analysis
Interviews will be recorded using a secured Google Hangouts platform to provide accurate accounts of participant discussions and then transcribed verbatim and checked for accuracy Only the audio component of the interview will be recorded not the video component in order to protect the privacy of participants The design conduct and dissemination of this research will be guided by the COREQ Checklist Semi-structured interviews will be guided with an interview schedule and topic guide Recordings will be transcribed by the third party transcription company Rapid Transcriptions The investigators will take a subtle realist position to allow the inclusion of a-priori knowledge and use an inductive thematic analysis To report themes and patterns within the data NVivo 12 for Windows will be used to assist with the organisation and retrieval of data The design conduct and dissemination will be guided by the COREQ Checklist The transcripts will be read by two of the team
Considerations
The investigators will use young people friendly age applicable materials and tools to facilitate conversations such as TALKING- MATs a system in which the participant can use pictures or actions and answers in order to help facilitate their communication A pre-interview questionnaire will be performed to inform the interviewer of patient status prior to starting A traffic light system will also be introduced to allow the patient to express their desire to stop the interview if they feel the need to
Phase 2 Logic model of factors
Objectives
To establish a list of factors that contribute to weight change in paediatric MS and NMOSD patients
To create a logic model of the problem and contributing factors
Methods
The research team will integrate the findings from the first three stages of the program of work including background foundation work review and audit and the Phase 1 interviews perspectives of patients families and clinicians A list of factors that contribute to weight changes in this population will be identified based on the extraction of data form the previously completed scoping review data audit and the interviews completed in the previous stage In keeping with the Intervention Mapping methodology structuring this research project a logic model will be created These factors will be in the domains of environment behaviour clinical features and treatment
Phase 3 Stakeholder Meetings
Objectives
Obtain input from a stakeholder panel to decide measures factors and outcomes
Finalise the content and delivery protocols of the intervention
Co-design the program and context of use including delivery systems and content to sit within the care pathway
Participants
N12 4 clinicians 4 parent 4 young people with MS or NMOSD
Participants from Phase 1 and the research team will be invited to participate considering the same inclusionexclusion criterion Four parent and patients members will attend the meetings with our research team in person while four our consulting clinicians will attend the meeting via video call through the Google Hangouts platform
Methods
The logic model created in Phase 2 which outlines all the identifiable factors that contribute to weight change will be presented to the panel of key stakeholders in co-production workshops There will be two workshops in the form of meetings These will be run on a virtual platform via Google Hangouts and ideas recorded using a virtual whiteboard No audio or video recordings will be taken Real-time Board inc Miro is compliant with GDPR and is registered and certified with the Cloud security alliance httpscloudsecurityallianceorgstarregistryrealtimeboard-inc for meeting industry standards
Meeting 1 development This meeting will review and identify outcomes in order to finalize content by bringing together evidence from the literature clinical data and the perspectives of patients families and clinicians The investigators will use a modified nominal group approach following the steps preparation of logisticsfocus silent idea generation round-robin recording of ideas serial discussion of ideas preliminary consensus formation discussion and final agreement of logic model and intervention and evaluation plan and intervention Provisional program outcomes and objectives will be established and a logic model of change The research team will then co-design the lifestyle weight management program by generating program themes components and delivery protocols
Meeting 2 consensus The program and its themes components and protocols will then be presented to the panel during the second meeting The same nominal group methodology will be used as in the first session Feedback will be obtained regarding recruitment participation implementation and adherence in order to put forth the most appealing program for patients parents clinicians and researchers Following the second meeting adjustments to the program will be made so that it is ready for the feasibility stage
STUDY SETTING Phase 1 Interviews
This is a multi-centre study and will involve virtually interviewing patients parents and clinicians at their homes or at one of our three sites listed below
John Radcliffe Hospital Oxford UK Great Ormond Street Hospital London UK Evelina Hospital London UK The decision to conduct interviews through these sites was made with the patient in mind as the data collection will be integrated into the patients bi-annual clinic in which they travel to the hospitals for the completion of several appointments The interview will last approximately 45-60 minutes and will be in-cooperated into their appointment schedule for that day Furthermore as the patients regularly attend these hospitals the research site will be familiar to them The interviewee will be set up in a room located on one of the three aforementioned study sites or at their home This option has been added in order to accommodate for any participants that might not deem it safe enough to visit one of the three research sites during the current status of the COVID global pandemic The decision to perform the interviews virtually was made following current COVID guidelines in order to protect both interviewer and interviewee through the limitation of contact and consequently lowering of risk The interviewer will be located in a private room at Oxford Brookes University Recruitment will also occur at these three sites and will be performed by the clinical nurse associated to the appropriate MSNMOSD team at each site prior to the scheduled interview days
Phase 3 Stakeholder Meetings This phase of the research will occur virtually via the same Google Hangouts platform as Phase 1 Participants will be asked to attend two stakeholder meetings occurring on two different days
Sample identification and recruitment Phase 1 Interviews Potential eligible participants young people and their parents will be identified by the clinical nurse located at each of our three research sites JR in Oxford GOSH and Evelina in London from their current list of patients The role of the nurse will involve participant identification and eligibility checks Once potential participants have been identified the clinical nurse will mail out a patient information package containing research team contact information alongside their bi-annual appointment reminder The potential participants will then have the option to opt into the study Potential health care practitioners will be identified by our lead clinicians and clinical nurses and will be contacted by the research nurse via email
Phase 3 Stakeholder Meetings Participants young people and parents for phase 3 will be existing participants recruited from those who participated in Phase 1 During the consent procedure for phase 1 the participants will have the option to consent to being contacted by the research team regarding future research those who consent will be recruited for phase 3 Health care professionals that are currently members of our advisory team will be included No further recruitment will be necessary
Consent Informed Consent The participant must sign and date the latest approved version of the Informed Consent form before any study specific procedures occur
Written and verbal versions of the Participant Information and Informed Consent will be presented to the participants detailing no less than the exact nature of the trial what it will involve for the participant the implications and constraints of the protocol the known side effects and any risks involved in taking part It will be clearly stated that the participant is free to withdraw from the trial at any time for any reason without prejudice to future care without affecting their legal rights and with no obligation to give the reason for withdrawal
The participant will be allowed as much time as wished to consider the information and the opportunity to question the Investigator their GP or other independent parties to decide whether they will participate in the trial Written Informed Consent will then be obtained by means of participant dated signature and dated signature of the person who presented and obtained the Informed Consent Informed assent will be sought from any participant aged 10-15 as well as informed consent from their parentguardian There will be child friendly Participant Information Sheets catered for those aged 10-15 so as to assure their assent is well informed The person who obtained the consent must be suitably qualified and experienced and have been authorised to do so by the ChiefPrincipal Investigator A copy of the signed Informed Consent will be given to the participant The original signed form will be retained at the trial site Outcomes will be analysed after recruitment of the last participant in the trial Phase 1 of the study will close once the final participant has completed their interview Informed consent for Phase 3 will commence after the completion of Phase 1 and the informed consent procedure will remain the same
Withdrawal and loss to follow-up Parents guardians of participants and the participants have the right to withdraw consentassent for participation in any aspect of this trial at any time Routine medical care will not be affected at any time by declining to participate or withdrawing from the trial The investigators will make every effort to reduce loss to follow-up One primary contact within each centre will contact all participants and act as liaison with the assessor and therapy team The primary contact person will obtain information about the participants preferred method of contact text telephone email and letter and trial researchers will contact them using this preferred method when possible Contact details will be updated if applicable at each assessment All appointments will be made at the research participants convenience wherever possible If an appointment is missed the investigators will try to rearrange this on one more occasions
Aim
To co-develop a comprehensive lifestyle weight management program catered specifically for paediatric patients with demyelinating conditions such as multiple sclerosis MS and neuromyelitis optica spectrum disorder NMOSD
Objectives
1 To explore perspectives and perceptions regarding weight change health and quality of life through semi-structured interviews of young people with MS and NMOSD their parents and clinicians
2 To establish a list of factors that contribute to weight change in the paediatric MS and NMOSD patients following steroid treatment mapped out in a logic model
3 To co-design a lifestyle weight management program for paediatric MS and NMOSD patients through the compilation of information and data obtained and the input from stakeholder meetings
Outcome
The final outcome of this study will be a lifestyle weight management program that is ready for a feasibility trial It will output a set of end-user requirements as well as a fully formed underpinning logic model
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS
Method overview
Building on a previously completed scoping review and an audit of the research teams pre-existing patient data and information from the collaborating institutions this stage of the research involves three distinct phases
Phase 1 Foundational co-development- Interviews
Phase 2 Logic model of factors
Phase 3 Program design and implementation plan- Stakeholder Meetings
Phase 1 Interviews Young people with MS or NMOSD their familiescarers and health care professionals HCPs will participate in interviews to gain perspectives and perceptions with regards to weight change in order to develop a suitable intervention for implementation in the care pathway
Design
Participatory design with semi-structured interviews
Objectives
Describe the factors affecting the management of these conditions with regards to quality of life health and wellbeing
Identify potential modifiablenon-modifiable factors that contribute to weight change in this population
Highlight and extract important concerns and themes and explore the barriers and facilitators to implementing a lifestyle management system for this population within the care pathway
Participants
15 young people aged 10-25 with MS or NMOSD Including MOG
15 parentscarers
15 health care practitioners from medical nursing and AHP backgrounds with at least two years experience in NMOSD and MS
N 45
Method
Semi-structured interviews underpinned by a thematic analysis with patients parents and clinicians The questions will be focused around predetermined themes and factors extracted from the previously performed scoping review and data audit and involving nutrition weight changes overall health and quality of life The team psychologist will co-develop questions related to behaviour and The nutritionist and exercise specialist will co-develop in their respective fields The PPI members will co-develop all interview formats and methods There will be three different versions of the questions one for patients one for parents and one for clinicians The interview questions will remain consistent throughout the study
Procedure
Interviews with parents patients and HCPs will be performed virtually via video call using the secured Google Hangouts platform Invitations to join the link will be sent via email and events will be made private
The participants will have the option to participate while at home or at one of the three research sites during one of their clinical appointment days It is foreseen that patients and their parents will participate virtually from their home however should they need assistance or accommodation this will be provided by one of our three research sites In this case the clinical nurse will assist with the virtual interview when the patient is present at one of the hospitals for their bi-yearly day of clinical appointments Clinicians will also be given the option to either participate virtually from home or from one of the research sites The interviewer will perform the interview from a private room at Oxford Brookes University Parents will be interviewed on their own whereas patients will be interviewed with their parent present- if under 16 Patients aged 16 years may have their parents present should they wish but the parent will be asked not to contribute The estimated interview time is 45- 60 mins subject to change during the development process There will be a brief post interview questionnaire where the participants will be given the opportunity to mention anything they might not have been able to discuss in the interview It will also allow for the research team to collect data with regards to the execution of the research and to consequently assess the chosen methods
Analysis
Interviews will be recorded using a secured Google Hangouts platform to provide accurate accounts of participant discussions and then transcribed verbatim and checked for accuracy Only the audio component of the interview will be recorded not the video component in order to protect the privacy of participants The design conduct and dissemination of this research will be guided by the COREQ Checklist Semi-structured interviews will be guided with an interview schedule and topic guide Recordings will be transcribed by the third party transcription company Rapid Transcriptions The investigators will take a subtle realist position to allow the inclusion of a-priori knowledge and use an inductive thematic analysis To report themes and patterns within the data NVivo 12 for Windows will be used to assist with the organisation and retrieval of data The design conduct and dissemination will be guided by the COREQ Checklist The transcripts will be read by two of the team
Considerations
The investigators will use young people friendly age applicable materials and tools to facilitate conversations such as TALKING- MATs a system in which the participant can use pictures or actions and answers in order to help facilitate their communication A pre-interview questionnaire will be performed to inform the interviewer of patient status prior to starting A traffic light system will also be introduced to allow the patient to express their desire to stop the interview if they feel the need to
Phase 2 Logic model of factors
Objectives
To establish a list of factors that contribute to weight change in paediatric MS and NMOSD patients
To create a logic model of the problem and contributing factors
Methods
The research team will integrate the findings from the first three stages of the program of work including background foundation work review and audit and the Phase 1 interviews perspectives of patients families and clinicians A list of factors that contribute to weight changes in this population will be identified based on the extraction of data form the previously completed scoping review data audit and the interviews completed in the previous stage In keeping with the Intervention Mapping methodology structuring this research project a logic model will be created These factors will be in the domains of environment behaviour clinical features and treatment
Phase 3 Stakeholder Meetings
Objectives
Obtain input from a stakeholder panel to decide measures factors and outcomes
Finalise the content and delivery protocols of the intervention
Co-design the program and context of use including delivery systems and content to sit within the care pathway
Participants
N12 4 clinicians 4 parent 4 young people with MS or NMOSD
Participants from Phase 1 and the research team will be invited to participate considering the same inclusionexclusion criterion Four parent and patients members will attend the meetings with our research team in person while four our consulting clinicians will attend the meeting via video call through the Google Hangouts platform
Methods
The logic model created in Phase 2 which outlines all the identifiable factors that contribute to weight change will be presented to the panel of key stakeholders in co-production workshops There will be two workshops in the form of meetings These will be run on a virtual platform via Google Hangouts and ideas recorded using a virtual whiteboard No audio or video recordings will be taken Real-time Board inc Miro is compliant with GDPR and is registered and certified with the Cloud security alliance httpscloudsecurityallianceorgstarregistryrealtimeboard-inc for meeting industry standards
Meeting 1 development This meeting will review and identify outcomes in order to finalize content by bringing together evidence from the literature clinical data and the perspectives of patients families and clinicians The investigators will use a modified nominal group approach following the steps preparation of logisticsfocus silent idea generation round-robin recording of ideas serial discussion of ideas preliminary consensus formation discussion and final agreement of logic model and intervention and evaluation plan and intervention Provisional program outcomes and objectives will be established and a logic model of change The research team will then co-design the lifestyle weight management program by generating program themes components and delivery protocols
Meeting 2 consensus The program and its themes components and protocols will then be presented to the panel during the second meeting The same nominal group methodology will be used as in the first session Feedback will be obtained regarding recruitment participation implementation and adherence in order to put forth the most appealing program for patients parents clinicians and researchers Following the second meeting adjustments to the program will be made so that it is ready for the feasibility stage
STUDY SETTING Phase 1 Interviews
This is a multi-centre study and will involve virtually interviewing patients parents and clinicians at their homes or at one of our three sites listed below
John Radcliffe Hospital Oxford UK Great Ormond Street Hospital London UK Evelina Hospital London UK The decision to conduct interviews through these sites was made with the patient in mind as the data collection will be integrated into the patients bi-annual clinic in which they travel to the hospitals for the completion of several appointments The interview will last approximately 45-60 minutes and will be in-cooperated into their appointment schedule for that day Furthermore as the patients regularly attend these hospitals the research site will be familiar to them The interviewee will be set up in a room located on one of the three aforementioned study sites or at their home This option has been added in order to accommodate for any participants that might not deem it safe enough to visit one of the three research sites during the current status of the COVID global pandemic The decision to perform the interviews virtually was made following current COVID guidelines in order to protect both interviewer and interviewee through the limitation of contact and consequently lowering of risk The interviewer will be located in a private room at Oxford Brookes University Recruitment will also occur at these three sites and will be performed by the clinical nurse associated to the appropriate MSNMOSD team at each site prior to the scheduled interview days
Phase 3 Stakeholder Meetings This phase of the research will occur virtually via the same Google Hangouts platform as Phase 1 Participants will be asked to attend two stakeholder meetings occurring on two different days
Sample identification and recruitment Phase 1 Interviews Potential eligible participants young people and their parents will be identified by the clinical nurse located at each of our three research sites JR in Oxford GOSH and Evelina in London from their current list of patients The role of the nurse will involve participant identification and eligibility checks Once potential participants have been identified the clinical nurse will mail out a patient information package containing research team contact information alongside their bi-annual appointment reminder The potential participants will then have the option to opt into the study Potential health care practitioners will be identified by our lead clinicians and clinical nurses and will be contacted by the research nurse via email
Phase 3 Stakeholder Meetings Participants young people and parents for phase 3 will be existing participants recruited from those who participated in Phase 1 During the consent procedure for phase 1 the participants will have the option to consent to being contacted by the research team regarding future research those who consent will be recruited for phase 3 Health care professionals that are currently members of our advisory team will be included No further recruitment will be necessary
Consent Informed Consent The participant must sign and date the latest approved version of the Informed Consent form before any study specific procedures occur
Written and verbal versions of the Participant Information and Informed Consent will be presented to the participants detailing no less than the exact nature of the trial what it will involve for the participant the implications and constraints of the protocol the known side effects and any risks involved in taking part It will be clearly stated that the participant is free to withdraw from the trial at any time for any reason without prejudice to future care without affecting their legal rights and with no obligation to give the reason for withdrawal
The participant will be allowed as much time as wished to consider the information and the opportunity to question the Investigator their GP or other independent parties to decide whether they will participate in the trial Written Informed Consent will then be obtained by means of participant dated signature and dated signature of the person who presented and obtained the Informed Consent Informed assent will be sought from any participant aged 10-15 as well as informed consent from their parentguardian There will be child friendly Participant Information Sheets catered for those aged 10-15 so as to assure their assent is well informed The person who obtained the consent must be suitably qualified and experienced and have been authorised to do so by the ChiefPrincipal Investigator A copy of the signed Informed Consent will be given to the participant The original signed form will be retained at the trial site Outcomes will be analysed after recruitment of the last participant in the trial Phase 1 of the study will close once the final participant has completed their interview Informed consent for Phase 3 will commence after the completion of Phase 1 and the informed consent procedure will remain the same
Withdrawal and loss to follow-up Parents guardians of participants and the participants have the right to withdraw consentassent for participation in any aspect of this trial at any time Routine medical care will not be affected at any time by declining to participate or withdrawing from the trial The investigators will make every effort to reduce loss to follow-up One primary contact within each centre will contact all participants and act as liaison with the assessor and therapy team The primary contact person will obtain information about the participants preferred method of contact text telephone email and letter and trial researchers will contact them using this preferred method when possible Contact details will be updated if applicable at each assessment All appointments will be made at the research participants convenience wherever possible If an appointment is missed the investigators will try to rearrange this on one more occasions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None