Lifestyle and Non-motor Symptom Management in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title: Views and Priorities of Lifestyle Factors in the Management of Non-motor Symptoms in Parkinson's Disease: Qualitative Interviews and Consensus Workshops With Patients, Caregivers, and Healthcare Professionals

Status Terminated

Clinical Trial Summary

Parkinson's Disease (PD) has generally been thought of as a movement disorder however other health-related symptoms, known as non-motor symptoms, are also very common. Non-motor symptoms can be very broad and present in numerous conditions, making identifying the symptoms of early-stage Parkinson's disease very difficult. Non-motor symptoms, including fatigue, and problems with sleep and mood, can happen decades before motor symptoms and have a greater impact on quality of life and psychological wellbeing. Despite this treatment options for non-motor symptoms are limited and therefore the development and testing of new treatments is a main priority.

Due to the limited treatments options available, self-management of symptoms through positive lifestyle changes is a warranted area of research. The perspectives amongst patients, caregivers, and HCP's regarding lifestyle behavior change and its impact on fatigue and related non-motor symptoms has yet to be investigated in detail. This study includes two stages: telephone interviews and online consensus workshops. Patients with PD whom have experience of fatigue, partners/caregivers and Healthcare professionals will be able to participate in interviews only, workshops only or both. The interviews will investigate patients, partners/caregivers and Healthcare Professionals views and priorities of lifestyle factors in the management of non-motor symptoms in Parkinson's disease as well as identifying factors that influence lifestyle changes amongst PD patients. Stage 2 will involve small consensus workshops to generate ideas and feedback related to the design and content of the soon-to be developed lifestyle program. Results from both stages of this study will be used to help develop and design a lifestyle management program for fatigue and associated non-motor symptoms in Parkinson's Disease.

Clinical Trial Description

Global aim: To assess stakeholders (patients, supportive individuals, and HCP's) views and priorities of lifestyle factors in the management of fatigue and related non-motor symptoms in Parkinson's disease, in addition to identifying facilitators and barriers to lifestyle-related behavior change, in order to inform the development of a subsequent lifestyle intervention.

The study consists of two stages:

1. Semi-structured interviews (lasting around 60 minutes)

2. Online consensus workshops using a nominal group technique (2x 60 minute sessions)

Setting: Both stages will be conducted remotely. For Stage 1 interviews will be conducted over the telephone (with or without videoconferencing). Stage 2 will use an online brainstorming platform to run the consensus workshop with concurrent videoconferencing.

Participants: For both stages' participants will include individuals with Parkinson's Disease, supportive individual's (partners/caregivers/family members/significant others) and healthcare professionals.

Analysis:

Stage 1- Interviews will be analyzed using thematic analysis and framework mapping onto the COM-B model. Themes will be deductively mapped onto the categories and its associated constructs of the Capability, Opportunity and Motivation to Behaviour (COM-B) model to identify specific targetable aspects of behavior that may need to be addressed in the subsequent lifestyle intervention. A secondary categorical form narrative analysis of the interviews will also be conducted to supplement the main group analysis by providing a detailed insight into the experiences and stories of participants in relation to lifestyle changes on an individual level.

Stage 2- Responses during the consensus workshop will be analyzed using frequency counts and descriptive. Data will include a complete list of ideas, scores allocated to each idea, the overall rank of each idea and any additional comments made by participants. ;

Related Conditions & MeSH terms

• Fatigue
• Parkinson Disease

• NCT number: NCT04837976
• Study type: Observational
• Source: Oxford Brookes University
• Status: Terminated
• Start date: May 14, 2021
• Completion date: October 7, 2021