Abstract
BackgroundPharmacological intervention is essential for managing the symptoms of Parkinson's disease. Adherence to medication regimens however is a major problem. Poor adherence leads to significant motor deterioration and inadequate symptom control. This results in poor quality of life. Whilst interventions to improve medication adherence have shown considerable benefit in other chronic conditions, the efficacy of such treatments in Parkinson's disease is less well researched. Many people with Parkinson's disease require substantial support from spouse/caregivers. This often extends to medication taking. Consequently, spouse/caregiver's support for timely medication management is paramount. We aim to investigate the benefit of a novel intervention, Carer Assisted Adherence Therapy, for improving medication adherence and quality of life in people with Parkinson's disease. Adherence therapy may help to optimise the efficacy of anti-parkinsonian agents, subsequently improving clinical outcomes.Methods/DesignA 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.Trial RegistrationISRCTN: ISRCTN07830951
Highlights
Pharmacological intervention is essential for managing the symptoms of Parkinson’s disease
For drugs requiring multiple daily doses, researchers reported only 3% fully adhered to medication regimens [23]. These findings suggest medication non-adherence is significant in people with Parkinson’s disease (PD)
Beliefs about Medication Questionnaire (BMQ) The BMQ is comprised of two scales: (1) an 11 item questionnaire relating to prescribed medication, (2) an 8 item questionnaire relating to general views about taking medication
Summary
Pharmacological intervention is essential for managing the symptoms of Parkinson’s disease. Poor adherence leads to significant motor deterioration and inadequate symptom control This results in poor quality of life. Many people with Parkinson’s disease require substantial support from spouse/caregivers. We aim to investigate the benefit of a novel intervention, Carer Assisted Adherence Therapy, for improving medication adherence and quality of life in people with Parkinson’s disease. 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]. As motor and NMS have considerable impact on QoL in PD, addressing both is an integral part of management
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