%0 Journal Article %T The use of carer assisted adherence therapy for people with Parkinson's disease and their carers (CAAT-PARK): study protocol for a randomised controlled trial %A David J Daley %A Katherine HO Deane %A Richard J Gray %A Paul F Worth %A Allan B Clark %A Kanagasabesan Sabanathan %A Michael Pfeil %A Phyo K Myint %J Trials %D 2011 %I BioMed Central %R 10.1186/1745-6215-12-251 %X A parallel, randomised controlled trial will be conducted to investigate whether carer assisted adherence therapy is effective for improving medication adherence and quality of life. We aim to recruit 40 patient/carer pairs into each group. Participants will be randomly assigned by the Clinical Research Trials Unit at the University of East Anglia. Adherence therapy is a brief cognitive-behavioural approach aimed at facilitating a process of shared decision making. The central theory is that when patients make shared choices with a professional they are more likely to continue with those choices because they are personally owned and meaningful. Outcomes will be rates of adherence and quality of life, determined by the Morisky Medication Adherence Scale-4 and the Parkinson's disease Questionnaire-39 respectively. Assessments will take place post randomisation, immediately post intervention and 12-weeks post randomisation. Primary outcomes are adherence and quality of life at 12-week follow-up. Efficacy will be determined using intention-to-treat analysis. Independent samples t-tests will compare mean changes between groups from baseline to follow-up. Per protocol analysis will be conducted based on individuals with no major protocol deviation. Where imbalances in baseline characteristics are identified, an adjusted analysis will be performed using a regression model. Analysis will be masked to treatment allocation.ISRCTN: ISRCTN07830951Parkinson's disease (PD) is a progressive, disabling, neurodegenerative disease that significantly reduces quality of life (QoL) [1,2]. Debilitating symptoms of bradykinesia (slowness of movement), resting tremor, rigidity and postural instability are principal features of PD [1,3]. In addition to these motor symptoms, non-motor symptoms (NMS) such as cognitive impairment, dementia, sleep disturbances, depression and falls are significantly associated with reduced QoL [4]. Cognitive impairment is reported to affect 20-30% of patients w %K Parkinson's disease %K Medication %K Adherence %K Adherence Therapy %U http://www.trialsjournal.com/content/12/1/251