BackgroundMultidisciplinary rehabilitation is recommended for Parkinson’s disease, but evidence suggests that benefit is not sustained.Objectives(1) Implement a specialist domiciliary rehabilitation service for people with Parkinson’s and carers. (2) Provide continuing support from trained care assistants to half receiving the rehabilitation. (3) Evaluate the clinical effectiveness of the service, and the value added by the care assistants, compared with usual care. (4) Assess the costs of the interventions. (5) Investigate the acceptability of the service. (6) Deliver guidance for commissioners.DesignPragmatic three-parallel group randomised controlled trial.SettingCommunity, county of Surrey, England, 2010–11.ParticipantsPeople with Parkinson’s, at all stages of the disease, and live-in carers.InterventionsGroups A and B received specialist rehabilitation from a multidisciplinary team (MDT) – comprising Parkinson’s nurse specialists, physiotherapists, occupational therapists, and speech and language therapists – delivered at home, tailored to individual needs, over 6 weeks (about 9 hours’ individual therapy per patient). In addition to the MDT, participants in group B received ongoing support for a further 4 months from a care assistant trained in Parkinson’s (PCA), embedded in the MDT (1 hour per week per patient). Participants in control group (C) received care as usual (no co-ordinated MDT or ongoing support).Main outcome measuresFollow-up assessments were conducted in participants’ homes at 6, 24 and 36 weeks after baseline. Primary outcomes: Self-Assessment Parkinson’s Disease Disability Scale (patients); the Modified Caregiver Strain Index (carers). Secondary outcomes included: for patients, disease-specific and generic health-related quality of life, psychological well-being, self-efficacy, mobility, falls and speech; for carers, strain, stress, health-related quality of life, psychological well-being and functioning.ResultsA total of 306 people with Parkinson’s (and 182 live-in carers) were randomised [group A,n = 102 (n = 61); group B,n = 101 (n = 60); group C,n = 103 (n = 61)], of whom 269 (155) were analysed at baseline, pilot cohort excluded. Attrition occurred at all stages. A per-protocol analysis [people with Parkinson’s,n = 227 (live-in carers,n = 125)] [group A,n = 75 (n = 45); group B,n = 69 (n = 37); group C,n = 83 (n = 43)] showed that, at the end of the MDT intervention, people with Parkinson’s in groups A and B, compared with group C, had reduced anxiety (p = 0.02); their carers had improved psychological well-being (p = 0.02). People with Parkinson’s in groups A and B also had marginally reduced disability (primary outcome,p = 0.09), and improved non-motor symptoms (p = 0.06) and health-related quality of life (p = 0.07), compared with C. There were significant differences in change scores between week 6 (end of MDT) and week 24 (end of PCA for group B) in favour of group B, owing to worsening in group A (no PCA support) in posture (p = 0.001); non-motor symptoms (p = 0.05); health-related quality of life (p = 0.07); and self-efficacy (p = 0.09). Carers in group B (vs. group A) reported a tendency for reduced strain (p = 0.06). At 36 weeks post recruitment, 3 months after the end of PCA support for group B, there were few differences between the groups. Participants reported learning about Parkinson’s, and valued individual attention. The MDT cost £833; PCA support was £600 extra, per patient (2011 Great British pounds).ConclusionsFurther research is needed into ways of sustaining benefits from rehabilitation including the use of care assistants.Study registrationCurrent Controlled Trials: ISRCTN44577970.FundingThis project was funded by the National Institute for Health Research Health Services and Delivery Research programme and the South East Coast Dementias and Neurodegenerative Disease Research Network (DeNDRoN), and the NHS South East Coast. The report will be published in full inHealth Services and Delivery Research; Vol. 2, No. 51. See the NIHR Journals Library website for further project information.
Health-related quality of life and psychological well-being in elderly patients with haemophilia
