Cross-sectional study assessing Patient-reported outcome measure in PD
Research type
Research Study
Full title
A Single-Site Longitudinal Study to Assess a New Patient-Reported Symptom and Motor-Related Impact Questionnaire in Individuals with Parkinson’s Disease
IRAS ID
308541
Contact name
Nicola Pavese
Contact email
Sponsor organisation
Newcastle upon Tyne Hospital Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
When assessing potential new treatments for Parkinson’s disease (PD), it is an important requirement that any treatment effect should be relevant and meaningful to people with this condition and, in particular, should have a positive impact on their daily lives.
The impact of PD symptoms on the activities of daily living is generally assessed with patients’ questionnaires. The questionnaires that are currently used to measure the impact of Parkinsons symptoms are able to capture important changes in later stages of the disease. However, they are not very good at detecting mild changes in ability to perform daily activities, particularly in the early stages of the disease. People in the early stages of Parkinson’s disease reported that although they were still independent, they did have to modify their routine or took longer to perform typical daily activities. Clinical scales that can capture these early changes are currently not available.In this study, we will evaluate two newly developed patient-reported questionnaires in participants with early PD: the Parkinson’s disease - Motor Impacts Questionnaire (PD-MIQ) and the Parkinson’s disease – Symptom Questionnaire (PD-SyQ). These scales were developed by interviewing people with PD. The measures have been developed to address the challenges with assessing mild changes in daily function. The PD-MIQ assesses the impact of motor symptoms on specific aspects of daily function, and the PD-SyQ assesses the severity of motor and non-motor symptoms, and the impact of these symptoms on overall daily function.
The aim of this study is to evaluate how well the two questionnaires, PD-MIQ and PD-SyQ, are suited to PD in the early stages and if they are able to address the measurement gap identified for other questionnaires used in Parkinson’s disease.
We intend to enroll 300 participants with early PD who attend the Movement Disorder Clinic at Newcastle upon Tyne Hospital Trust. On two separate occasions, at the time of their routine clinical visits, patients who have consented to take part in the study will be asked to fill in the two questionnaires and a short cognitive assessment in addition to the assessments performed as standard of care.
The findings of the study would allow us to gain important information about the new questionnaires and how well they are capturing the impact of Parkinson’s disease on the daily life of people living with the disease.
REC name
West of Scotland REC 4
REC reference
22/WS/0030
Date of REC Opinion
11 Mar 2022
REC opinion
Favourable Opinion