An observational study in Parkinson Disease and Fatigue, sponsored by Oxford Brookes University. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by Oxford Brookes University · Observational
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.
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:
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 41 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Oxford Brookes University is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
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Patients and Supportive Individuals will be recruited from a Neurology clinic at Oxford University Hospitals NHS Foundation Trust (OUHFT) and from the Parkinson's UK website. Healthcare proffesionals will be recruited via the Parkinson's UK Excellence Network.
A) Patients
B) Supportive person (partner/family member/caregiver)
C) Healthcare Professionals
Exclusion criteria
A) Patients
B) Partners/Caregivers
C) Health Care Professional
Other: Semi-structured interviews and a consensus workshops using nominal group techniques.
For example carers, family members or any other individual providing regular support or care to the person with Parkinson's.
Other: Semi-structured interviews and a consensus workshops using nominal group techniques.
Other: Semi-structured interviews and a consensus workshops using nominal group techniques.
Stage 1 of the study includes individual remote semi-structured interviews (one per participant). Stage 2 involves taking part in a consensus workshop with around 7 other Parkinson's experts, consisting of patients, supportive individuals and healthcare professionals.
Themes related to the views and priorities of lifestyle factors in relation to fatigue and non-motor symptom management in Parkinson's Disease.
Time frame: Assessed during the interview (60 minutes) after enrollment
Facilitators to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease.
Time frame: Assessed during the interview (60 minutes) after enrollment
Barriers to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease.
Time frame: Assessed during the interview (60 minutes) after enrollment
Identified behavioral targets for the intervention as indicated by the mapping of themes onto the COM-B model (capability, opportunity or motivation)
Time frame: Assessed during the interview (60 minutes) after enrollment
A list of potential methods of intervention delivery, structure and content, ranked in order of preference created during consensus workshops.
Time frame: From participation in the first consensus session after enrollment until session 2 (around 1-2 weeks later)
Parkinson's Fatigue Scale (PFS-16)
A patient-rated scale that measures fatigue in Parkinson's disease ranging from 0 to 80.. A Score of 8 or above indicates the presence of significant fatigue. Higher scores correspond to worse fatigue.
Time frame: Once prior to the interview and/or consensus workshop.
Becks Depression Inventory (BDI-II)
A 21-item self-reported questionnaire with scores for each item ranging from 0 (absence of symptoms) to 3 (severe symptoms). Total scores range between 0 and 63 with higher scores indicating greater severity of depressive symptoms.
Time frame: Once after enrollment, prior to the interview- patients only
Geriatric Anxiety Scale (GAS)
Self-reported assessment of anxiety symptoms amongst older adults. Scores range from 0 to 20, with scores of 0-8 indicating an absence of clinically significant anxiety and scores of 9 and above indicating the presence of clinically significant anxiety.
Time frame: Once after enrollment, prior to the interview- patients only
Apathy Evaluation Scale (AES)
Self-reported assessment of apathy symptoms. The total AES score ranges between 18 to 72 with a lower score indicating greater apathy.
Time frame: Once after enrollment, prior to the interview- patients only
Parkinson's Disease Sleep Scale (PDSS-2)
Self-rated assessment to quantify the level of sleep disruption in Parkinson's Disease. Scores range from 0 to 60, with higher scores representing more severe nocturnal disturbance.
Time frame: Once after enrollment, prior to the interview- patients only.
Plan to share: No
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Oxford Brookes University