777777
Patient Focus Issue
Vol. 2, Issue 9, Oct 2015.
R&D Newsletter
VICKY DUFFY: ACT-MOVE
ACT-MOVE is an open-label, phase III study evaluating the efficacy and safety of a new treatment for
patients who experience severe rheumatoid arthritis
(RA). The treatment being tested in ACT-MOVE
has been available as an intravenous infusion since
2010, but this can incur high amounts of drug wastage and significant hospital stays; the trial is
therefore investigating the viability and effectiveness
of a subcutaneous injection.
At 45, Vicky Duffy is one of the younger patients
taking part in the trial. She has been experiencing
severe RA for five years, and the condition affects
her ability to climb stairs, walk to the shops, and
other basic daily tasks. She has been experiencing regular and acute flare-ups constantly for some
time, and to this end was asked to take part in ACTMOVE by the trial’s principal investigator, Dr Sophia
Khan.
“Since being on the study,” Vicky says, “I’ve
experienced at most two flare-ups a month rather
than one every other day. And the CRP levels in my
bloods are low, too; they’ve really come down.”
When she was asked to take part in ACT-MOVE,
Vicky had never heard of clinical trials, and had little
idea of what one was. She was given a lot of
information, and given a whole month to consider
her decision (due to the nature of its inclusion
criteria, ACT-Move recruitment requires a lot of
forward-planning).
“In all honesty, I agreed in desperation, really - I was
so keen to find another treatment.” That said, Vicky
is now a convert to the clinical trial process, and
would definitely take part in another like ACT-MOVE
- provided, of course, she received the usual
support to understand the “ins and outs”.
Since the trial began with weekly consultations at
hospital - reducing over time to fortnightly and then
monthly meetings - a large part of Vicky’s enthusiasm comes down to how well she’s got on with the
trial’s research team.
“They’re so friendly,” Vicky says of them. “They
explain everything and make me feel informed and
comfortable. I’m very lucky.”
The importance of good communication between
research nurses and trial participants is clear - but
ACT-MOVE is just as lucky to have a patient as
diligent as Vicky taking part.
THE ROLE OF THE RESEARCH NURSE:
Jane Rudge
Florence Burford, 79, has been experiencing heart
problems and diabetes for some time. On one
of her visits to hospital for a check-up, she was
provided with a form to register for a research trial
– and thought that it sounded like a good way to
give something back. Florence was enrolled on
the Reveal trial, which is focused on assessing
the effectiveness of the drug Anacetrapib in
combating the effects high cholesterol.
Florence’s relationship with her research nurse,
Leena Andrews, has been important to her
experience of taking part in research. “She is
absolutely brilliant!” Florence enthuses. “In fact,
one time I went to see her I was complaining
about pains in my chest – I thought it was just my
usual angina playing up. But Leena thought
differently, wheeled me straight over to A&E …
and twelve days later I had a quadruple by-pass!”
That’s a conclusion also reached by another
research trial participant at HEFT, Susan Ford: “I
had a funny turn after my first injection,” she says.
“Leena was with me the whole time, and, although
I kept telling her I was fine, she was there when
even I had to admit I wasn’t feeling right!” Leena
immediately booked Susan into a bed; she
eventually spent a night in the resuscitation ward.
Susan’s lipoprotein-A levels are in the 300s,
and she is currently prescribed a 250mg dose
of Pravastatin to be taken every night. She has
a consultation with Dr Alan Jones every three
to six months, and in the autumn of last year he
suggested to her that she might like to consider
volunteering for the ISIS trial.
Within a few days, Susan had received “lots” of
information from Leena, and decided that after
reviewing all that material if her involvement could
help others, then it was worth taking part. The ISIS
drug is injected subcutaneously every
other week. Between her first session and May
2015, Susan had injections in her stomach, on both
left and right, and in her left and right arms. It was
her final session, which involved an injection in one
of her legs that led to her ‘funny turn’.
Other participants have had much greater success,
of course. Jane Rudge has been a Critical Care
sister for twenty-six years, so had an understanding
of research and its role in healthcare well before
she every enrolled on her own first trial. But two
years ago that’s exactly what she did, when invited
to take part in the Focus study by Dr Alan Jones.
Jane has a hereditary high blood cholesterol
condition. It has been largely symptomless – she
only found out about it through routine health
checks – but in recent years has developed
heart disease, resulting in her having stents fitted at
the unusually early age of 56.
“That’s why Dr Jones was so keen for me to enrol
on Focus,” Jane explains. “I have been on statins
for many, many years, but they have never really
brought my cholesterol levels down to anything like
a safe or normal level. The drug being tested by
RECRUITMENT, REASSURANCE AND CARE
Focus, however, had hopes of being much more effective.”
Focus was a twelve-month trial, and the treatment it
trialled brought Jane’s cholesterol down to an almost
acceptable level – reducing it by thirty per cent. For
the last six months following the close of Focus, then,
Jane has been taking part in an open label stage of
the research, knowingly continuing to take the drug
because of these beneficial effects on her condition.
“The initial stage of the trial was double-blind, of
course,” Jane adds, “but due to some reactions I had
to the treatment, I more or less knew I was on the
drug rather than the placebo. Hopefully, it will soon be
licensed – we’re hoping within twelve months – and
I’ll be able to take it full-time.”
For Florence, too, taking part in a trial had a positive
impact on her health – if in her case indirectly.
Despite her bad experience with the increased levels
of statins, the trial has had some positive impacts
upon her health regime after all.
“It if doesn’t help me, it’ll help someone else,” she
says, echoing a common sentiment amongst patients
who volunteer for trials. All patients on Reveal are
given Atorvastatin to ensure good control of ‘bad’
cholesterol; they will also receive either a daily dose
of Anacetrapib or a placebo. “I was already on statins,
so while on the trial my dose doubled from 40mg to
80mg.”
In the event, something about this increase caused
Florence serious trouble with her arthritis, so six
months after commencing the trial she asked her
research nurse, Leena Andrews, whether the drugs
could be discontinued.
“After I left Reveal, my GP even put me down further
to 20mg because the effects had been so bad!”
Florence says. She has since had further bloods, and
her cholesterol is now very low.
Jane, meanwhile, will return to regular statins, but
in full knowledge that her participation in a trial has
helped advance not just treatment in general – but
her own in particular. “I would definitely take part in
other trials in the future. The support from Dr Jones
and the Leena has simply been exceptional.”
Susan, meanwhile, is still receiving care from Leena,
who’s still taking my bloods to maintain safety; and
Florence speaks for each of them when she suggests
that their research nurse’s professionalism and great
rapport with patients is key to the success of any trial
– for patients, it makes all the difference.
Susan Ford
ALZHEIMERS: SUSAN AND MALCOLM PRICE
Susan Price was diagnosed with Alzheimer’s in July
2013. “She’s in denial,” says her husband, Malcolm,
“and that’s for the best: she nursed her father through
the disease, and knows how bad it can get.”
The Prices are aware that at present there is no cure
for this dreadful illness, and that research is the only
way to fight a disease that runs in Susan’s family. At
70, Susan’s diagnosis is still in its earliest stages and the ELAD trial, with Professor George Tadros as
its head, offers her the hope of a new and effective
treatment. For them, it is indeed the only light at the
end of a dark tunnel.
Liraglutide, a drug most commonly used in patients
with diabetes, is the focus of the trial: delivered via
self-administered injections, the drug is known to
have some effects on the levels of amyloid plaques
in the brain. There is already promising data on its
effectiveness from mice trials.
Half of the trial’s cohort is receiving Liraglutide, the
other half a placebo; as a double-blind trial, neither
Professor Tadros nor the Prices know which
treatment Susan is receiving. “Even if we’re getting
the placebo,” says Malcolm, “at least we’re helping to
hopefully find a cure.”
Susan and Malcolm live in South Yorkshire, but when
they learned about ELAD they were happy to make
trips to Birmingham and London. At first, Susan
was screened by Professor Tadros using a range of
memory tests; when she passed these, the Prices
were sent to London - all expenses paid - and Susan
underwent three hours’ of brain scans.
Throughout the term of the trial, Malcolm now administers daily injections to Susan, and she has bloods
taken once a month in Birmingham. They are
currently four months into the trial, and at six months
Susan will undertake another memory test. She will
take another such test at the end of the twelve-month
trial - and return to Imperial College in London for a
second batch of brain scans.
Malcolm hopes that the results will be positive for
Susan, but also for the treatment as a whole: even
if Susan is currently on the placebo, he hopes that a
successful Liraglutide therapy will be able to help his
wife in the future.
Indeed, the Prices’ commitment to the trial has seen
Malcolm putting up recruitment posters in clinics and
support groups in their hometown of Barnsley, in the
hope that it will encourage other suitable patients to
get involved. “We need to find a cure for this
disease,” he says, “together. It’s that simple.”
EXPERIENCING RESEARCH: JULIE & MARTIN
SIROCCO:
JULIE SHELDON
“I’m doing well at the moment,” Julie says, almost as soon
as our conversation begins. “Whether that’s the trial or
not, I don’t know!”
The trial to which Julie refers is Sirocco, which is
investigating the effectiveness of Benralizumad added
to high-dose corticosteroid in patients with uncontrolled
asthma. Julie has now completed most of the course of
injections - ten of a projected twelve - and is showing
good improvement.
“I have experienced really severe bouts of asthma for a
long time,” she says. “I’m easily allergic to pollens,
airborne mould, and so on - and especially around
September and February times my breathing goes downhill very rapidly from around 6.30pm in the evening.”
Julie has been part of trials before, and currently utilises
a breathing machine she first began to use as part of a
study. During one of her prolonged attacks, which she has
experienced since the age of eleven and have become
worse since the birth of her second son, an inhaler simply
has no effect.
Based in Derby, Julie was referred to Heartlands
Hospital’s Dr Mansur, an expert in the field. One trial to
which he referred her - which introduced extra antihistamines to her regimes - had a huge impact, but Julie
was still having time off work or at times unable even to
read to her children.
Taking part in Sirocco, however, has coincided with a
healthier time. “My skin looks better, my usage of
Ventolin has reduced, and my lung capacity has been
quite good,” Julie says. “This could be due to different
weather conditions - only time will tell.”
For Julie, however, research represents “the light at the
end of the tunnel”. She hopes taking part in the trials will
help both her and her family - but also believes that if her
participation helps anyone then it will have been
worthwhile. Her commitment to research is such that,
bumping into a friend recently, she decided to become
involved in a study they were taking part in, giving blood
as part of the research.
“Whatever happens with Sirocco,” she says, “I know the
information we collect will be useful in the next trial - and
maybe the one after that!” So far, so good.
REVEAL:
MARTIN MORGAN
Martin Morgan experienced a heart attack in 2010, subsequently undergoing surgery for the fitting of stents. During
his recovery period, he found himself looking for ways to
stay engaged with healthcare – and keep in touch with
people who had also had cardiac surgery. “I’d have otherwise been on my own,” he says, “and it just seems a better
idea to share experiences, to give and receive support
from others.”
When he was offered a post-operative preview of what
to expect by medical staff, included in the information he
was provided was a leaflet or two about clinical trials and
research. Feeling it was a good way to stay engaged with
care, and to help other people on statins like him, he enrolled on the Reveal trial.
“I started on the trial in late 2011,” he remembers, “so I
have only one or two sessions left at this point.” At each
session, Martin has his blood pressure taken, provides
various samples, and has his cholesterol taken.
He does not know, of course, whether he is on the Reveal
drug or the placebo – but research has helped him join and
build a real community that has supported him in his ongoing treatment and recovery.
“I’ve joined and become a patient co-ordinator for the Solihull Heart Support Group,” he says, referring to the patient
group funded through a donation given twenty years ago
by another individual who had experienced a heart attack.
“We meet every third Wednesday of the month – and I’ve
ensured that some of our guest speakers have been researchers looking to recruit! Hopefully, we can all help and
support each other to improve our own health – but also
that of others.”
PAEDIATRIC RESEARCH: HALIMA
Halima is just sixteen, but speaks about her involvement with a clinical trial studying a new
drug for asthma with a maturity that belies her years. “My symptoms have been quiet severe
for a long time,” she explains. “I have a lot of sleepless nights and constant wheeziness. I’m
allergic to dust, trees – everything, really. It’s been that way since I was two or three.”
Halima has at one point or another tried every inhaler available. Steroids have helped to
manage her condition, but never impacted greatly upon the severity of her symptoms.
Little surprise, then, that she was asked to join a clinical trial investigating potential new
treatments. Initially, she was recruited for a trial other than the one in which she is currently
participating – but allergies meant she was soon switched to her current trial.
“It is a very complicated study with daily diaries and daily Peak Flow tests to be done at home,” says paediatric research
nurse Jacqueline Daglish. “There are also monthly visits to hospital with two injections each time, blood tests, Spirometry
tests, plus more – all of which takes most of the day.”
At first, Halima was put off by all this – joking that it seemed like she was provided with “hundreds” of pages of information.
But she also says that Jacqui and her team were so approachable and helpful that she soon began to change her mind. “If
it can help others, then great – but I also liked the idea that I’d be in more regular contact with the hospital, which helps me
manage my asthma better,” she says.
The trial has also helped Halima get over her fear of injections – and with two injections each month she gets plenty of
practice in getting over her phobia. She is currently in the first year of this regime, during which patients are either given a
placebo or a high or low dose of the drug; in the second year, no placebo is provided and all patients are placed on one of
the two dose regimens.
“Even if I’m not having the drug,” Halima says, “I’m still getting help with my asthma. I’d definitely take part in another trial
if it was appropriate to me – not only is research a good thing in itself, I’ve found it has really helped me understand my
condition, take it more seriously, and manage it more effectively.”
ONLINE HEFT RESEARCH RESOURCES
R&D information and resources are available online via both the internet and intranet.
You can find us on the HEFT internet site, at http://www.heartofengland.nhs.uk/research/
These research web pages can also be accessed from the main HEFT website via the main navigation links.
The pages contain an overview of research - and in the near future will contain information on all the research
which which we are involved at HEFT. Finally, the page also contains information on how we are doing with our
NIHR targets, as detailed in our previous issue.
Those performance statistics can also be reached directly via http://www.heartofengland.nhs.uk/research/nihrperformance-statistics/
On the intranet, we have added a Toolkit page to our Research and Development pages, which contains lots of
useful research templates.
We are trying to encourage people to have a look, make use of the resources, and leave feedback or any
comments – we want to know about anything you’d like changing, or any further resources you’d like to see
added to the pages. So let us know! The pages are here for you.
Finally, the open access HEFT Repository was developed by the HEFT Library Knowledge Services and aims
to list all the publications that members of staff have authored as part of their roles in the Trust since 2008.
It is available through the Intranet, located under the Repository heading. You can search the repository using a
variety of criteria – keywords, author, divisions, and latest additions.
0121 424 0835
www.heartofengland.nhs.uk/research