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Recruitment for the first stage has been completed. However the research team no longer has the staff or resources to complete stage 2 of the research.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with Parkinson's Disease |
| ||
| Supportive individuals | For example carers, family members or any other individual providing regular support or care to the person with Parkinson's. |
| |
| Healthcare Professionals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-structured interviews and a consensus workshops using nominal group techniques. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Themes related to the views and priorities of lifestyle factors in relation to fatigue and non-motor symptom management in Parkinson's Disease. | Assessed during the interview (60 minutes) after enrollment | |
| Facilitators to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease. | Assessed during the interview (60 minutes) after enrollment | |
| Barriers to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease. | 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) | 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. | From participation in the first consensus session after enrollment until session 2 (around 1-2 weeks later) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Once prior to the interview and/or consensus workshop. |
| Becks Depression Inventory (BDI-II) |
Inclusion criteria
A) Patients
B) Supportive person (partner/family member/caregiver)
C) Healthcare Professionals
Exclusion criteria
A) Patients
B) Partners/Caregivers
C) Health Care Professional
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Lawrie | Oxford Brookes University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Brookes University | Oxford | Oxfordshire | OX3 0BP | United Kingdom |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
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. |
| 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. | 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. | 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. | Once after enrollment, prior to the interview- patients only. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |