medicine virtual imageFour important clinical research projects led by academic clinicians in the School of Medicine, Trinity College Dublin have emerged as winners in the recently announced Definitive Intervention and Feasibility Awards (DIFA) 2023 results. The major awards, funded through the Health Research Board (HRB), supports researchers and research teams to conduct high-quality definitive intervention trials and feasibility studies.

The four awardees will investigate improved care and treatment pathways for significant health challenges including: Multimorbidity (Prof. Susan Smith) Hypertension (Prof Martina Hennessy and Dr. Cormac Kennedy) Work and Cancer (Prof. Deirdre Connolly), Cocaine use disorder (Dr John Kelly).

These awards will advance the School of Medicine’s strategy to grow a dynamic clinical trials ecosystem facilitated by the Clinical Wellcome-HRB Clinical Research Facility at St James's Hospital. More detail on each new award under the 2023 scheme are outlined below.

DIFA 2023 Project details:

1. Title of Research Project  Medicines and SocIal Prescribing to aDdress pAtient priorities in multimorbidity (MIDAS): A multi-arm (definitive) cluster randomized trial in Irish general practice

Name, Title  of Lead PI 
Professor Susan Smith, Professor of General Practice, Discipline of Public Health & Primary Care, TCD

Multimorbidity is recognised as a key challenge facing patients and health systems. There is a need for cost-effective interventions that improve health outcomes in this population. We have conducted two separate pilot trials, one supporting GPs to manage polypharmacy in patients with multimorbidity (MyComrade) and the other providing link workers to deliver social prescribing for patients with multimorbidity (LinkMM). Both interventions have the capacity to be integrated into Ireland’s new Chronic Disease Management (CDM) Programme.

The MIDAS trial aims to evaluate the clinical and cost-effectiveness of two separate multimorbidity interventions to support GPs managing medicines (MyComrade) and to support patients addressing their priorities (LinkMM) in order to improve patients’ health outcomes, experience of care and well-being

Speaking about the award, Professor Smith said: 

This award provides an opportunity to evaluate much needed interventions to support the management of people living with multiple long term conditions in Ireland in order to improve their health outcomes and experience of care”. 

2. Title of Research Project  Semaglutide for people with obesity and resistant hypertension trial (SUPPORT): a pilot randomised, double blind, parallel group, multicentre trial

Name, Title  of Lead PI 
Professor Martina Hennessy, Assoc Professor Consultant, Medical Education, Trinity College Dublin & Director of Wellcome HRB-Clinical Research Facility, St. James’s Hospital
Dr. Cormac Kennedy, Clinical Senior Lecturer, Trinity College Dublin & Associate Director, Wellcome-HRB Clinical Research Facility at St James's Hospital.

Hypertension is the leading risk factor for morbidity and mortality globally, yet its management remains inadequate. Resistant hypertension (RH) refers to patients with uncontrolled blood pressure (BP) on at least three anti-hypertensive agents, including a diuretic. Patients with RH are more likely to have obesity and cardiovascular disease. Treatment of RH is problematic and necessitates new approaches. The Semaglutide Treatment Effect for People with obesity trials provide evidence of the positive effect of semaglutide, a glucagon like peptide-1 receptor agonist (GLP1-RA), on body weight and BP.

The research question is whether a weight-centric approach, using semaglutide, for patients with obesity and RH, but without diabetes, results in a clinically meaningful reduction in BP versus standard care. A pilot randomised, double blind, parallel group, multicentre trial will be performed to inform an international, multicentre definite study.

This initial study will inform how a larger trial can be best planned and run. Ultimately, this work will help us to understand whether weight lowering medicines can be used to improve difficult to control blood pressure, health and well-being.

Speaking about the award, Professor Hennessy said: 

Re-visiting the treatment of resistant hypertension through the lens of obesity marks a new approach to treating this complex chronic disease

3. Title of Research Project 

Investigating the effectiveness of Work and Cancer for women with breast cancer

Name, Title  of Lead PI 
Professor Deirdre Connolly, Discipline of Occupational Therapy, TCD

Over half of women diagnosed with breast cancer in Ireland are below the age of 64 years. Although cancer treatment is very successful, and women are now living longer with cancer, many women have persistent symptoms that interfere with their ability to return to work.

Going back to work is an important milestone in recovery from cancer. However up to 40% of women do not go back to work because of physical and psychological difficulties that interfere with their ability to meet the demands of their work. These include fatigue, ‘chemo-brain’, pain, and distress.

Collaborating with women with breast cancer and healthcare providers, we designed a unique online programme, Work and Cancer, that provides women with breast cancer with strategies to manage post-treatment difficulties and information on their work entitlements and supports.

Women who took part in a pilot study of Work and Cancer told us that it increased their confidence to communicate their work-related needs to their employers and gave them strategies to manage post-treatment symptoms. They said the programme was “powerful”, “invaluable”, “very comprehensive” and “supportive”. One woman told is “there’s a lot written about work and cancer but there’s nothing that pulls it into a one-stop package like this”.

No similar programme is available for cancer survivors nationally or internationally. This is the first programme specifically designed to prepare people with cancer to successfully return to work.

Work is an important part of peoples’ daily routine. It provides financial security, socialisation, a sense of identity and has societal benefits. People with cancer often consider return to work as an important milestone in their recovery from cancer and a sign of returning to ‘normal life’. It is therefore important that services are provided to support cancer survivors to negotiate what is often a very difficult process.

This funding will enable us to test the effectiveness of Work and Cancer with a larger group of women with breast cancer and to evaluate the cost effectiveness of the Work and Cancer programme. If we find that Work and Cancer is effective in supporting women with breast cancer to return to work, we hope it will be available as routine cancer survivorship care in Ireland.

Speaking about the award, Professor Connolly said: 

Returning to work is very important for cancer survivors. This funding allows us to test a unique service that will help them to achieve this goal.

4. Title of Research Project: POSITRON - PsilOcybin with pSychologIcal supporT foR cOcaiNe - A pilot feasibility trial of psilocybin therapy for cocaine use disorder

Name, Title of Lead PI 
Dr John R. Kelly, Consultant Psychiatrist & Clinical Senior Lecturer, School of Medicine

Cocaine use disorder has a detrimental impact on the individual, their families and on society. Psilocybin therapy, a synergistic combination of pharmacology and psychological support is emerging as a multi-modal treatment paradigm that is showing therapeutic benefits for addiction disorders, such as alcohol and tobacco addiction. Psilocybin activates cortical 5-HT2A receptors, induces transient alterations of brain connectivity, and promotes synaptogenesis and neural plasticity. It is not yet known whether psilocybin therapy will play a therapeutic role in cocaine use disorder.

We envisage that this pilot feasibility study will provide the necessary preliminary data to pave the way for a larger clinical trial to assess if psilocybin with psychological support will promote cocaine abstinence, reduce craving, and reduce rates of relapse in treatment seeking adults with cocaine use disorder.

Speaking about the award, Dr Kelly said: 

Cocaine remains the highest presentation for treatment of adults in Ireland. This award provides a much needed opportunity to develop a comprehensive treatment strategy to help people recover