Trial ID: ISRCTN16483203
Other - Phase Unknown - No longer available
Background and study aims In the UK, the number of people with Parkinson's disease (PD) will reach over 168,000 by 2025. At diagnosis, 19% of people with Parkinson's will have cognitive impairment, with symptoms including memory loss, difficulty concentrating and anxiety. Up to 78% of people with Parkinson's will develop Parkinson's dementia with symptoms such as confusion, hallucinations, and depression. As symptoms of Parkinson’s progress, people with PD require increasing support from an informal (unpaid) care partners to help maintain quality of life. 69% of carers of people with moderate to advanced PD report moderate to severe levels of strain. Lack of adequate support leads to carer breakdown and avoidable NHS and social care costs. Despite their important role, there is a scarcity of support for carers of people with PD with cognitive impairment. Making sure carers maintain their physical and mental health is crucial. The World Health Organization has developed iSupport, a programme for carers of people with dementia that aims to prevent and/or decrease the mental and physical health problems associated with caring and improve quality of life. It is available online, or as a paper booklet, and provides information and training for carers to take care of themselves, provide everyday care and deal with complex behaviour changes. iSupport is a useful resource, but it does not currently meet the specific needs of carers of people with Parkinson's with cognitive impairment. The aims of this study are to: (1) adapt iSupport for carers of people with Parkinson's with cognitive impairment; (2) check the programme is relevant and useful for these carers; and (3) test that the research procedures for a future evaluation are practical and achievable. Who can participate? Adults (aged 18+ years) who self-identify as an unpaid carer (partners, children, friends etc) of a person with Parkinson’s and cognitive impairment, who is not living in a full-time care facility, caring at least weekly for at least 6 months. The care recipient must have symptoms of cognitive impairment (through self-report of the care partner, to reflect the ‘real world’ application of iSupport-PD). What does the study involve? Participants are randomly allocated to either use the iSupport-PD website or usual care. Different modules within the iSupport-PD website provide information, skills training, and support using problem-solving, communications skills, stress management (e.g. relaxation), and cognitive behavioural therapy (e.g. psychoeducation, cognitive reframing, behavioural activation) techniques that care partners can work through independently. What are the possible benefits and risks of participating? There is the potential for participants to experience emotional distress caused by data collection. It is necessary to collect this data, but the researchers will signpost participants to support groups, Parkinson's UK services and GP services. Some participants may find the time to complete questionnaires burdensome, however, the study will only use validated questionnaires agreed upon by the PPI group. It is intended that iSupport PD will enable carers to have the knowledge, skills, and confidence to better manage their own health and well-being; to better support and co-manage the symptoms of the person with PD with cognitive impairment; to feel empowered in their role and become a valuable member of the multidisciplinary team; and to successfully access available support and resources. This could improve quality of life for both carers and people with PD and lead to better utilisation of health and social care resources, reduce hospital admissions and long-term care home placement. Ultimately, iSupport-PD could support the carers of over 10 million people with PD around the world. The distribution of iSupport-PD and the research findings have the potential to raise health and social care professional awareness of carer needs, along with the need to signpost to appropriate information and support and recognise the value of the carer as an integral member of the multidisciplinary team and feel better able to support carers. Where is the study run from? Northumbria University (UK) When is the study starting and how long is it expected to run for? June 2023 to February 2026 Who is funding the study? National Institute for Health and Care Research - Research for Social Care NIHR204259 (Research for Social Care Competition 4) (UK) Who is the main contact? 1. Prof. Annette Hand, a.hand@northumbria.ac.uk 2. Mrs Dilupa Samarakoon, dilupa.samarakoon@northumbria.ac.uk
Northumbria University
Source: https://www.isrctn.com/