Trial ID: ISRCTN16783200
Other - Phase Unknown - No longer available
Background and study aims This trial is called the PRIME Parkinson Randomised Controlled Trial (RCT). Parkinson's disease is a condition in which parts of the brain become progressively damaged over many years leading to shaking, stiffness, and difficulty with walking, balance, and coordination. Current models of care are not optimised for people with Parkinson’s and the wide range of symptoms and different experiences they may encounter. Current care can be slow to react to changes in symptoms, communication between different healthcare providers can be problematic, and including patients in optimal decision-making based on their unique circumstances is challenging. This trial aims to find out whether a new model of care, termed “PRIME Parkinson Care” is helpful for people living with Parkinson’s. We want to ascertain whether this new model can support people to live well with Parkinson’s. This trial compares a new additional model of care operating in tandem with their usual care provided by the UK National Health Service (NHS), against usual care on its own. Who can participate? We are inviting people with Parkinson’s and similar conditions, such as corticobasal degeneration, Lewy Body dementia, and vascular parkinsonism. However, people with drug-induced parkinsonism are ineligible and therefore excluded. In addition to having Parkinson’s, you need to be: · Over the age of 18 years · Willing to take part · Live in the catchment area of the RUH Bath Additionally, they must also be able to provide informed consent, or where unable to do so due to cognitive impairment, have the availability of a close friend or relative to act as a personal consultee. Patients who lack capacity but do not have someone to act as their personal consultee, unfortunately, cannot take part. What does the study involve? People taking part in the trial will be allocated to be in either group A or group B, with an equal chance of being allocated to either. The groups are chosen at random by a computer system, and participants will know which group they are in. In group A, participants will receive exactly the same care as they would if they were not in the trial. The only difference will be that they will be asked to complete some questionnaires and speak to our researchers on a regular basis. The information collected on these questionnaires will help us to find out if the new model of care is effective. ‘Usual care’ will be provided as normal through the NHS and other services. Participants will continue to be followed up in the usual way by their Parkinson’s consultant and nurse specialist. They will be given written information signposting them to ways of accessing help for Parkinson’s disease via their usual team. People in Group B will receive the PRIME Parkinson Care model. The PRIME Parkinson team will help support participants to achieve individually set goals for their treatment depending on which symptoms they find most difficult to manage. The PRIME Parkinson team will aim to personalise their care to their particular needs and priorities, and tailor their support accordingly. If they are allocated to receive PRIME Parkinson Care, they will continue to receive their usual care from their Parkinson’s team but will also be able to access all aspects of PRIME Parkinson Care. We anticipate that the PRIME Parkinson team will be the main source of support throughout the 2-year period, but they will work closely with the participant’s usual Parkinson’s specialist. PRIME Parkinson Care has a number of parts: · A ‘case manager’ to coordinate the care received from the PRIME Parkinson Care team and other healthcare professionals · A telephone number to contact the PRIME Parkinson Care team with any queries during office hours · A Personalised Care Plan booklet which will be completed jointly by the participant and the PRIME Parkinson Care team · Access to support and education to help them manage their Parkinson’s and to achieve their goals Participants in both groups will be asked to complete some questionnaires at home and to come to hospital for some assessments at the start of the trial, after 1 year and again after 2 years. They will also receive a telephone call from a member of the team approximately every 3 months. The questionnaires will be sent out to participant’s addresses for completion at home before attending hospital. What are the possible benefits and risks of participating? This trial is designed to improve the way in which care and support is provided for people living with Parkinson’s and similar conditions. We have designed a new approach to caring for people with Parkinson’s but do not know yet whether this approach is better than our current models of care. Taking part may not benefit every participant directly but it may benefit people with Parkinson’s in the future. We do not expect there to be any additional risks to participants relating to the new type of Parkinson’s care itself. Taking part in the trial will involve some assessments with the team and also answering some questionnaires. Some participants may find some of the questionnaire items to be quite personal (e.g. questions about recent thoughts and feelings), and some questions concern intimate topics (e.g. sexual activity, bladder and bowel function). If filling in the questionnaires raises issues or concerns, participants should discuss these with their specialist. Where is the study run from? Royal United Hospitals Bath (UK) When is the study starting and how long is it expected to run for? January 2021 to June 2025 Who is funding the study? The PRIME Parkinson RCT has been set up and sponsored by the University of Bristol in collaboration with the Royal United Hospital, Bath. The research is being funded by the Gatsby Charitable Foundation (UK) Who is the main contact? Dr Emily Henderson, prime-parkinson@bristol.ac.uk
University of Bristol
Source: https://www.isrctn.com/