Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04239664 |
| Other study ID # |
19019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2019 |
| Est. completion date |
March 20, 2020 |
Study information
| Verified date |
January 2020 |
| Source |
University of Nottingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
What is the purpose of the study?
People with Multiple Sclerosis often say that they feel less support is available after they
are diagnosed with Secondary Progressive Multiple Sclerosis, compared to before they received
this diagnosis. People sometimes experience a lessening of support, despite their physical
symptoms becoming more severe from both professionals and those in their personal lives. The
purpose of this study is to see whether providing some telephone support to those who have
recently received a diagnosis of Secondary Progressive Multiple Sclerosis is experienced as
helpful and is possible to do practically. This study will help the investigators understand
which type of support may be helpful for patients in the future and may pave the way for
larger studies and changes to NHS provision.
Who is it for?
Participants will be those who have transitioned recently (within the last year) to Secondary
Progressive Multiple Sclerosis. The investigators are inviting 40 participants to take part.
What will happen to participants if they take part?
Participants will be asked by their Neurologist or MS Nurse to take part in the study and
will provide written consent to be contacted, which will be stored by the research team.
Their details will be passed to the study team at the University of Nottingham, who will
telephone the participant within a week to tell them a bit more about the study and ensure
they are suitable for the study by asking them some questions. Following this, the
participant will be sent some paper or online questionnaires to complete and return. After
this, the researcher will visit the participant face to face to introduce themselves and
answer any questions they may have. They will also tell the participants what "group" they
have been randomly put into. There are two groups.
Those in the first group would be asked to commit to receiving a 30 minute support phonecall
each week for five weeks in addition to any usual care, and the second group will receive
their usual NHS care. The support phonecalls will draw from techniques used in a type of
psychological therapy (acceptance and commitment therapy). All the phonecalls can be done
whilst the participant is at home or in a quiet place of their choosing. After this, both
groups will fill in some more paper questionnaires eight and twelve weeks after the start of
the study. The investigators expect that participants will be involved in the study for
around 4 months.
After the study, participants will also have the opportunity to feedback how they experienced
being a participant in the study. Their responses will help the researchers understand their
experience, and help them use this to think about how to adapt similar studies in the future.
Description:
Brief Summary
Introduction
People with Multiple Sclerosis often say that they feel less support is available after they
are diagnosed with Secondary Progressive Multiple Sclerosis, compared to before they received
this diagnosis. People sometimes experience a lessening of support, despite their physical
symptoms becoming more severe from both professionals and those in their personal lives. The
purpose of this study is to see whether providing some telephone support to those who have
recently received a diagnosis of Secondary Progressive Multiple Sclerosis is experienced as
helpful and is possible to do practically. This study will help the investigators understand
which type of support may be helpful for patients in the future and may pave the way for
larger studies and changes to NHS provision.
Objectives
To assess the feasibility of providing a low-resource acceptance-based telephone support
intervention around the time of transition to Secondary Progressive Multiple Sclerosis
Trial Configuration
A single centre, mixed-methods feasibility randomised controlled trial (RCT), comparing two
groups: (1) Acceptance Based Support + usual care; (2) usual care.
Setting Secondary care. Single centre: Nottingham Hospital and community
Sample size estimate N maximum: 40 people with Secondary Progressive Multiple Sclerosis
(SPMS) (20 participants per group)
In addition to this, the investigators aim to recruit 12 of the participants for the nested
qualitative study.
Number of participants
The proposed number of participants for the study will be: 40 The proposed number of
participants for the interviews will be: 12
Description of interventions
Acceptance Based Telephone Support (ABS+UC): One face-to-face session to be informed of the
group they have been randomised into and Acceptance Based Support, followed by five 30-minute
telephone sessions of Acceptance Based Support. Usual care continues as normal.
Usual Care (Control Group) (UC): One face to face session to be informed of the group they
have been randomised into and encouraged to ask any questions, and will be informed they will
be contacted again in 8 weeks. Usual care continues as normal.
Duration of study
The study will take place over an 8-month period from September 2019 - April 2020.
Participation in the study will take each participant 4 months.
Data Collection: September 2019-February 2020 Analysis: February 2020-April 2020
Randomisation and blinding
Once the decision to include a person with MS is made, they will be randomised to one of two
groups in a ratio of 1:1: (1) ABS+UC or (2) UC. Block randomisation of 2, 4, 6 and 8 will be
used to ensure parity between groups, and randomly selected block sizes will be used.
Randomisation will be conducted using an online sealed envelope service
(www.sealedenvelope.com), to generate a priori the random allocation sequence. Due to the
nature of the intervention, the pwMS and CM delivering the treatment cannot be blinded to
group allocation, but outcome assessors will be blinded. Analysis will also be undertaken
blinded to group allocation.
Statistical methods
Quantitative analysis: As a feasibility trial, the main analysis will be descriptive and
focus on confidence interval estimation and not formal hypothesis testing. Descriptive
statistics will be used to describe outcomes and to inform power and sample size calculations
for a future trial. Rates of consent, recruitment and follow-up by randomised groups will be
reported. Based on the characteristics of the data, appropriate parametric and non-parametric
statistics will be used to describe trends.
Qualitative analysis: Framework approach
Extended Summary
INTRODUCTION
Multiple Sclerosis (MS) is the most common neurological condition affecting young adults. For
the majority people with MS (pwMS), it presents initially as a series of relapses, each
followed by a period of recovery. When there is a lack of disease progression between these
relapses; this is referred to as Relapsing-Remitting MS (RRMS). For many of those with RRMS,
this develops into a progressive disorder with an absence of relapse then recovery, but more
typically a gradual decline in function. This is called Secondary Progressive Multiple
Sclerosis (SPMS), and is defined by progressive accumulation of disability after an initial
RRMS course; which may or may not contain sharp episodes of decline during progression. This
progression from RRMS to SPMS happens within 15 years of initial diagnosis in 50% of cases
and takes a median of 20 years.
There is a significant clinical challenge for health professionals in objectively identifying
the transition from RRMS to SPMS in individuals due to subtle changes in symptoms, and
receiving a new diagnosis can take an average of almost three years after onset of
progressive symptoms. From a psychosocial perspective, the transition from RRMS to SPMS is a
very difficult time for pwMS fraught with uncertainty. Clinicians describe the impact on pwMS
as receiving an SPMS diagnosis as having a similar effect of receiving the initial diagnosis.
Some of the challenges faced during this period are an adjustment towards unremitting
symptoms, a withdrawal of previous disease-modifying treatments, and ever greater activity
limitations.
It has been argued that transition to SPMS is a 'fear-point' of the disease, a crucial and
vulnerable time where ineffective support and insufficient communication can lead to patients
feeling 'devastated and demoralised', but where well placed 'supportive, encouraging and
compassionate' communications can be effective in addressing the attitudinal and
psychological aspects of the patient, and act as a 'buffer' for the emotional morbidity
associated with MS. In this vulnerable time, communication with pwMS ought to be considered
foundational to effective MS care, and that 'doing something rather than nothing can be
extremely important'. Loss of social support has been shown to be associated with depression,
in a population which is already susceptible to mood disorders due to being a neurological
and chronic condition.
The most consistent finding of a systematic review of the psychological factors that affect
adjustment in pwMS found that perceived stress and certain emotion focussed coping strategies
were related to worse adjustment. A strong predictor of health status in MS is self-efficacy,
which may represent an important source of coping with the burdens of MS.
Exploring the way in which pwMS regulate and cope with emotion therefore is a key
consideration. CBT states that modifying dysfunctional cognitions that contribute to
psychological distress is a cornerstone of the therapy process, and a central mediator of
therapeutic outcome. In contrast, ACT states that facilitating acceptance of emotional and
cognitive content is a central part of the therapeutic process. These differences can be
summarised as cognitive "reappraisal" in CBT or "acceptance" in ACT ways of regulating
emotion. These ways of regulating emotion have been compared in a study into the effects of
anxious arousal, which found that both cognitive reappraisal and acceptance strategies were
more effective than suppression for moderating physiological sensations, with the cognitive
reappraisal generally the most adaptive strategy in terms of reducing anxiety response.
In an NHS currently plagued by understaffed services, a sufficiently effective, low resource
psychological telephone support, which seeks to improve self-efficacy and techniques of
emotional coping is needed for those with SPMS. This study will assess the feasibility of
such an intervention, which is likely to appeal to pwMS, overworked healthcare staff, and
funders if it leads to a reduction in SPMS patients use of other services. The content of
this telephone support may benefit from a more acceptance-based regulation of emotion
considering the client group: in secondary progressive multiple sclerosis, negative illness
beliefs and distress may be entirely logical due to the debilitating nature of their
condition which may make CBT "reappraisal" unrealistic. For this reason, several previous
authors have argued ACT has utility over existing therapeutic models in long term conditions
and due to its growing evidence base and strong face validity, is being widely adopted by
health professionals working with long term conditions.
PURPOSE
As the AT-SPMS intervention is a 'complex intervention' (based on Medical Research Council
[MRC] definition); the investigators aim to evaluate the key feasibility parameters before
proceeding to a randomised controlled trial (RCT) to evaluate the clinical and
cost-effectiveness of the intervention in improving outcomes for pwMS during transition to
SPMS.
PRIMARY OBJECTIVE
The primary objective is to assess the acceptability and credibility of an acceptance-based
telephone support intervention provided during the transition to SPMS through a feasibility
RCT aimed at increasing physical activity and improving social relationships. This follows
NICE guidance towards recommendations for increasing activity in MS and research evidence
highlighting the importance of maintaining the psychological wellbeing of patients during
transition to SPMS and the importance of social relationships within this.
SECONDARY OBJECTIVES
The secondary objectives are to demonstrate proof of principle of the intervention by
gathering information about the process of change between the two treatment arms on
self-efficacy, emotional coping, and mood, and to gather feedback, through nested interviews,
on the intervention and study procedures.
TRIAL / STUDY DESIGN
TRIAL / STUDY CONFIGURATION
A single centre mixed methods feasibility randomised control trial (fRCT) is to be conducted
to assess the feasibility and optimal delivery of the acceptance based support intervention
with people recently diagnosed with SPMS. The fRCT will have two groups: (1) Acceptance Based
Support + Usual Care (ABS+UC) and (2) Usual Care (UC). Participants will be assessed at
Baseline, and then again at 8 and 12 weeks post-randomisation, with participation in the
study taking an estimated 4 months. A selection of the participants will then be invited to
complete feedback interviews. UC refers to the typical contact made to those recently
diagnosed with SPMS by the Neurology service.
Primary endpoint
The primary endpoints in this study relate to the feasibility of proceeding to a future RCT.
1. Acceptability and feasibility of trial procedures
2. Appropriateness of eligibility criteria, baseline and outcome measures, audio recording
of sessions and randomisation protocol
3. Success of recruitment strategy
4. Recruitment and retention rates
5. Estimation of sample size needed for a future RCT
6. Completion rates of outcome measures
Secondary endpoint
The secondary endpoints are to demonstrate proof of principle of the intervention by
gathering information about the process of change between the two treatment arms on
self-efficacy, emotional coping, and mood, and to gather feedback, through nested
interviews, on the intervention and study procedures.
RANDOMIZATION AND BLINDING
Once the decision to include a pwMS is made, they will be randomised to one of two
groups in a ratio of 1:1: (1) ABS+UC or (2) UC. Block randomisation of 2, 4, 6 and 8
will be used to ensure parity between groups, and randomly selected block sizes will be
used to avoid selection bias. Randomisation will be conducted using an online sealed
envelope service (www.sealedenvelope.com), to generate a priori the random allocation
sequence. Trial researchers will access the allocation for each participant by logging
in to this remote, secure internet-based randomisation system. Once a participant has
consented to the study and completed the baseline measures, the researcher will log into
the randomisation system and enter basic demographic information to receive the
allocation for that participant. The sequence of treatment allocations will be concealed
until interventions have all been assigned and recruitment, data collection, and all the
other assessments are complete.
TRIAL/STUDY MANAGEMENT
The University of Nottingham (UoN) will act as the Sponsor for the trial. UoN's Standard
Operating Procedures (SOPs) will be used to govern the conduct of all aspects of the
study. The Sponsor will ensure the trial is run in accordance with our University's
SOPs. The trial will be managed and co-ordinated from the Division of Psychiatry and
Applied Psychology, School of Medicine, University of Nottingham by the Trial Management
Group (TMG), consisting of all of the authors. The trial is funded by the Health
Education East Midlands.
The Trial Management Group (TMG) will meet bi-monthly to ensure milestones are achieved
as planned, and will be responsible for the day to day management of the trial. This
includes reviewing recruitment, randomisation, retention, data management, adherence to
protocol, patient safety, delivery and fidelity of the intervention, data quality and
timescales. The TMG will consist of all authors; the Chief Investigator (RdN), Trial
Manager (CM), Research Clinical Psychologist (NM), Research Fellow (GT), and Field
Supervisor (NE). The Trial Manager (referred to from here as TM) will contact other
co-authors for support should issues arise between TMG meetings.
The CI has overall responsibility for the study and shall oversee all study management.
The data custodian will be the CI.
Recruitment
Participants will be identified within 6 months of receiving a diagnosis of SPMS at the
Neurology Clinic at Queens Medical Centre (QMC, Nottingham) and will be told about the
study by their treating Neurologist or MS Nurse Specialist. If the potential participant
is interested in finding out more about the study, the treating clinician will gain
their written consent to contact which will be held in the study files, and their
contact details will be passed to the TM. The TM will make telephone contact within one
week to confirm their willingness to participate. If they are not interested, the pwMS
will be thanked for their time and excluded from the study. No further contact will be
made by the TM and their details will be permanently deleted.
Should the pwMS be interested in participating, the TM will send them an 'Information
for Participant' sheet and a copy of the consent form in the post or by email (based on
participant preference), and they will be informed that the TM will contact them over
the telephone in one week, which should give the material time to arrive and be read.
This call will enable the TM to enquire whether they have received the information,
allow them to explain the study in more detail, and answer any questions the interested
participant has about the study. If they are no longer interested, the person will be
thanked for their time and excluded from the study.
If the participant is still interested in participating, then a pack of outcome measures
will be posted to them, and they will be asked to complete these once they arrive. The
participant will be instructed to sign and return the consent form, and outcome measures
using the pre-paid envelope provided. Completing the consent forms and outcome measures
can also be done online, based on participant preference, which may help those
participants who are less readily able to travel. Once the consent form, and outcome
measures have been returned and the inclusion criteria have been determined to be met,
the person will be included in the study.
Twelve participants, six from each study arm, will be invited to take part in
qualitative interviews by the TM following their involvement in the study. These
participants will be telephoned to enquire about their interest, and if they would be
interested, will be posted or emailed (depending on preference) a Participant
Information Sheet (PIS) and a consent form.
It will be explained to the potential participant that entry into the trial is entirely
voluntary and that their treatment and care will not be affected by their decision. It
will also be explained that they can withdraw at any time but attempts will be made to
avoid this occurrence. In the event of their withdrawal it will be explained that their
data collected so far cannot be erased and the investigators will seek consent to use
the data in the final analyses where appropriate.
Removal of participants from therapy or assessments/Participant Withdrawal
Participants will be informed through the PIS and consent form that they are free to
withdraw from the study at any time without it affecting their normal care or legal
rights. The TM will attempt to replace those who withdraw from the study before
randomisation however since this is a feasibility study, participants who withdraw from
the study after randomization will not be replaced, but withdrawal rates and reasons
will be recorded (if the participants choose to give them). If a participant indicates a
wish to withdraw from the intervention, the investigators will enquire whether they will
consider completing the follow-up assessments.
Participants may be withdrawn from the trial either at their own request or at the
discretion of the TMG after discussion. If the participant requests to withdraw, efforts
will be made to contact the participant over the telephone or other preferred method to
understand and respond to their concerns. If participants continue to express they want
to withdraw, or do not respond, then they will be considered to have withdrawn. The
participants will be made aware that this will not affect their future care.
Participants will be made aware (via the PIS and consent form) that should they withdraw
the data collected to date cannot be erased and may still be used in the final analysis.
The TMG may remove a participant from the study where significant disease progression
makes aspects of the study impossible. e.g. loss of communication.
Withdrawal from the Acceptance Based Support programme is not considered a safety issue
for participants.
Informed consent
All participants will provide written informed consent. The Consent Form will be signed
and dated by the participant before they enter the trial. The TM will explain the
details of the trial and provide a PIS, ensuring that the participant has enough time to
consider participating or not. The TM will answer any questions that the participant has
concerning study participation. Informed consent will be collected from each
participant: one copy of this will be kept by the participant, one will be kept by the
TM. Informed consent will be gathered through one of the following routes before they
undergo any interventions, this includes postal or online consent.
Postal: Two copies of the Consent Forms will be posted to participants, who will be
requested to sign and date them. The TM will be available to discuss the information
sheet and consent form over the telephone with the participants. Once participants sign
the Consent Forms and complete the baseline questionnaires, they will return one consent
form and the questionnaires to the investigators using the pre-paid envelope provided.
They will keep one consent form for their personal records.
Online: Online informed consent will be created using online survey tools. The
'mandatory response' function of the online survey tool will be used to ensure obtaining
consent from the participants. In this way, participants must confirm they have read the
information page and each of the ethical statements. Only when they have 'clicked' to
confirm each statement will they be able to move forward to the online baseline
questionnaires. Should they wish to have a copy of the consent form, they will be able
to print the consent page. If they do not have a printing facility, the investigators
will print their consent form and send them a hard copy by post.
For the qualitative interviews, separate informed consent will be collected from the
patient participants before undertaking the interviews following the aforementioned
procedures. A separate PIS and Consent Form specific to the interviews will be provided.
Should there be any subsequent amendment to the final protocol, which might affect a
participant's participation in the trial, continuing consent will be obtained using an
amended Consent Form which will be signed by the participant.
TRIAL / STUDY TREATMENT AND REGIMEN
The investigators will test the feasibility and optimal delivery of the acceptance based
support intervention with people recently diagnosed with SPMS, by comparing two groups:
(1) Acceptance Based Support + Usual Care (ABS+UC) and (2) Usual Care (UC).
Interventions:
Acceptance Based Support + Usual Care (ABS+UC)
The ABS+UC arm will comprise appointments with the TM who will receive training and
supervision from an experienced clinical psychologist (the CI). This will take place
over a maximum of 6 sessions, with the first being a face to face session (60 minutes)
and the remaining delivered over telephone (30 minutes each). The content of the
sessions will be an acceptance based psychological support approach to tackling
maintenance of physical activity, and social avoidance. This will comprise of resources
which teach an Acceptance and Commitment Therapy (ACT) informed approach to wellbeing,
and will be tailored to the specific needs of the participant. A "Patient Workbook",
developed from previously designed self-help formats for ACT will be given to all
patients in the ABS+UC arm of the study. The workbook will be used as a supplement to
assist the guidance and support of the therapist and will not be a standalone self-help
intervention, following the recommendations of a recent systematic review and a
subsequent thesis.
Usual Care
In the UC arm, the participant will meet once with the TM face to face to be informed of
the group they have been randomised into and encouraged to ask any questions, and will
be informed they will be contacted again in 8 and 12 weeks and be asked to complete some
more outcome measures.
An encrypted UoN dictaphone will be used to audiotape a proportion (10%) of the
telephone intervention sessions. Audiotaping will take place in a practical way ensuring
that different time points of the intervention are captured. Fidelity to the ACT
intervention will then be cross-checked through comparing it against existing criteria
to ensure integrity to the model as outlined in an assessment manual.
Baseline and follow-up assessments
Participants will be assessed before randomisation at baseline. They will also be
assessed at 8 and 12 weeks after randomisation for follow up.
Demographic data and illness data will be collected at baseline, along with a number of
outcome measures detailed looking at mood, psychological flexibility, self efficacy etc.
The outcome measures will also be collected at follow up.
Participant Feedback Interviews
After the final participant has been randomised, up to 12 participants, six from the
ABS+UC and six from the UC condition, will be invited to take part in 30-minute,
semi-structured interviews about their experience of the study. A separate information
sheet and consent form will be completed in relation to the interviews. Participants
will be selected for interview through purposive maximum-variation sampling based on
demographic and illness data. An interview schedule will be used and applied flexibly. A
12-participant sample is a manageable number for a study of this size.
The interviews will be conducted by a trainee clinical psychologist researcher (under
supervision from a qualified clinical psychologist with an expertise in qualitative
methods) independent of the trial team who will explore the pwMS's experience of
receiving each condition, (i.e. what they found helpful or unhelpful, the content and
delivery of the intervention). Audio recording will be taken for all interviews and will
be transcribed verbatim. An external person/company will be used for transcribing the
interviews. A confidentiality agreement will be in place before transferring the
interview data to the external company. The transcribed data will be analysed using a
framework approach which is a hierarchical, matrix-based method developed for applied
qualitative research. Using this approach is appropriate as our goals are clearly
defined at the onset (i.e. to support the development of a future definitive trial).
STATISTICS
Methods
Qualitative Analysis
The feedback interviews will be transcribed by an external (GDPR compliant, and approved
by University of Nottingham) transcription service, and analysed by the TM using NVivo
data analysis software. A five step Framework Analysis approach will then be taken. This
approach involves use of a thematic framework a priori which helps to guide the content
of the interviews, which is appropriate for this study as the investigators have clearly
defined goals from the outset (i.e. to examine the feasibility of a future RCT trial).
In Framework Analysis, the data will be mapped onto a constructed thematic framework.
After mapping all the data, a matrix will be generated in which the data will be charted
to summarise each main theme. This matrix will then be used in the interpretation of the
data - in addition to the notes made during the coding process. To ensure rigour and
credibility of the findings, the generated matrix will be reviewed by another researcher
and the quotations for their relevance to the themes will be checked. Disagreements will
be resolved by discussion in the TMG.
Quantitative Analysis
As a feasibility trial, the main analysis will be descriptive and focus on confidence
interval estimation and not formal hypothesis testing. Descriptive statistics will be
used to describe outcomes and to inform power and sample size calculations for a future
trial. Rates of consent, recruitment and follow-up by randomised groups will be
reported. Based on the characteristics of the data, appropriate parametric and
non-parametric statistics will be used to describe trends.
SPSS for Windows will be utilised for the analysis of outcome measures, illness and
demographic data, and feasibility measures (e.g. number of missed appointments).
Frequencies and percentages of missed and rescheduled support calls, attrition rates and
adherence to outcome measures will be gathered. In addition, analysis of variance
(ANOVA) will be used to explore outcome data at different time-points, to allow for
calculation of effect sizes to help ascertain sample size predictions for a future RCT.
Regression will be used to help the investigators predict the likelihood of change,
using initial HADS scores, illness, and demographic factors as variables.
Sample size and justification
The recruitment target is to randomise 40 pwMS, based on recommended sample sizes
between 24 and 50 for feasibility RCTs. Recruiting 15 participants or above per study
condition is considered acceptable to obtain a reasonable sample size estimate for pilot
trial studies, and recent similar research of an 8-session telephone study comparing CBT
to supportive listening showed a consistent attrition rate across interventions with
this population of around 15%. Therefore, a slightly larger target (20 per arm) for 6
sessions will help to prepare for the possibility of a 25% attrition rate, whilst still
achieving the 15 participants per arm suggested to evidence a future RCT. An estimation
for the recruitment rate is to recruit five participants each month, between March 2019
and October 2019.
DATA PROTECTION
All trial staff and investigators will endeavour to protect the rights of the trial's
participants to privacy and informed consent, and will adhere to the Data Protection
Act, 2018. The CRF will only collect the minimum required information for the purposes
of the trial. CRFs will be held securely, in a locked room, or locked cupboard or
cabinet. Access to the information will be limited to the trial staff and investigators
and relevant regulatory authorities (see above). Computer held data including the trial
database will be held securely and password protected. All data will be stored on a
secure dedicated web server. Access will be restricted by user identifiers and passwords
(encrypted using a one way encryption method).
For online consent and questionnaires, an online survey tool (e.g. Online Surveys) will
be used, which complies fully with the General Data Protection Regulation. The
investigators will set up an account dedicated for the AT-SPMS study (only the research
team members will have access to this account). All online responses will be collected
over encrypted SSL connections and stored on the password-protected AT-SPMS online
survey account. The account will be checked by the research team on a weekly basis to
export the collected online data to a secure dedicated web server (Access will be
restricted by user identifiers and passwords). Once the online data (i.e. stored on the
online survey account) is exported to this secure dedicated web server, it will be
permanently deleted from the online survey account. Automatic IP collection option would
be turned off to maintain the participants anonymity.
Information about the trial in the participant's medical records / hospital notes will
be treated confidentially in the same way as all other confidential medical information.
Electronic data will be backed up every 24 hours to both local and remote media in
encrypted format.
