Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05070286 |
| Other study ID # |
F.02.2019.13 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2022 |
| Source |
Oxford Brookes University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 team's
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 families/carers 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 modifiable/non-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 parents/carers.
- 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 HCP's 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:
•N=12 (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 inclusion/exclusion 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
https://cloudsecurityalliance.org/star/registry/realtimeboard-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 logistics/focus, 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 hospital(s) 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 MS/NMOSD 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 parent/guardian. 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 Chief/Principal 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 consent/assent 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 participant's convenience wherever possible. If an appointment is missed
the investigators will try to rearrange this on one more occasions.
