Randomised controlled trial to assess the clinical- and cost-effectiveness of physiotherapy and occupational therapy in Parkinson’s disease (PD REHAB)

• United Kingdom

Department of Health (DH)

1597757

01-01-2009

60

• Parkinson’s disease

Parkinson Disease, Occupational Therapy, Physical therapy

The aim of PD REHAB is to evaluate the clinical and cost-effectiveness of NHS occupational therapy (OT) and physiotherapy (PT) in patients with Parkinson’s disease (PD) who report limitations in activities of daily living.

The trial is a large, pragmatic, multicentre, randomised, controlled trial of OT and PT versus no therapy in 750 patients with PD and limitations in activities of daily living from approximately 40 elderly care and neurology units throughout the United Kingdom.

PT and OT will be administered in the patient’s home. The framework for the content of the therapy will be agreed in advance by expert groups based on our previous work on standard NHS OT and the PT Evaluation Project. Therapy will be tailored to the individual patient’s requirements. Trial therapists will have a spectrum of experience, so we will provide an initial training day for therapists as they join the trial to ensure uniformity of practice across the country. Therapists providing the intervention will complete intervention record forms, as used in previous complex intervention trials, to allow us to monitor intervention delivery. We have successfully piloted some of these forms in the PD OT trial.

The primary outcome measure will be instrumental activities of daily living (Nottingham Extended Activities of Daily Living scale) as activities of daily living is the target of the intervention. Secondary outcomes will be: health-related quality of life (Parkinson’s Disease Questionnaire 39; EuroQol EQ5D), cost-effectiveness (cost per quality adjusted life year), adverse events and carer quality of life (Short Form 12. Outcomes will be assessed before randomisation and by post at 3, 9 and 15 months.

Physiotherapy (PT) and Occupational Therapy (OT) are thought to help people in different but complementary ways, which vary depending on the severity of the condition and the priorities of the individual patient. In general, physiotherapy treatment focuses on working with the patient, carer and family to improve their understanding of the condition, maintain general fitness and independence in mobility, both inside and outside the home. Occupational therapists support and help people to maintain their independence in daily living activities and to participate in society by identifying their physical, emotional and social needs. The occupational therapist then provides advice and suggests ways of planning activities, changing the environment, learning new strategies to cope with physical and psychological problems and using adaptive equipment effectively.

People with Parkinson’s, their carers and healthcare providers recognise the value of PT and OT. Indeed the National Services Framework (NSF) for Long Term Neurological Conditions and NICE guidelines recommend that people should have access to PT and OT. However, there is little research evidence to support the use of OT and PT and without this evidence it is very difficult for both service users and professionals working with them to be able to judge what they need, when they need it and what they can expect the outcomes to be. It also makes it difficult to plan services when little is known about the cost of therapy provided and the beneficial effects that can be expected. Similarly, it is very difficult to improve services and develop new treatments if we do not know the effectiveness of OT and PT as it is currently provided in the NHS.

We are planning to assess the effects of providing both OT and PT to people with Parkinson’s disease in their own homes. On the toss of a coin, half of the people with Parkinson’s disease in the trial will receive the service straight away and half will not. Those not receiving the service immediately will have access to therapy at the end of the study (e.g. 15 months later).

The effects of therapy intervention and their associated costs will be carefully measured using well established patient-completed questionnaires which will assess how they cope with everyday life activities (e.g. washing, shopping) and their quality of life. We will also ask patients to complete forms about what NHS services they use so that we can estimate the costs of providing their healthcare

• Clinical research