Clinical trial NCT04837976: Lifestyle and Non-motor Symptom Management in Parkinson's Disease
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson Disease
Fatigue
Keywords: Qualitative
Semi-structured interviews
Thematic analysis
Framework
Nominal Group Technique
Consensus methods
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion criteria

A) Patients

* A diagnosis of idiopathic Parkinson's Disease
* Age of 18 years or above
* Current or previous experience of persistent fatigue
* Able to communicate clearly in English over the telephone/online for over an hour
* Have access to a working computer and internet connection (required for stage 2 only).

B) Supportive person (partner/family member/caregiver)

* Age of 18 years or above
* A supportive person of an individual with Parkinson's Disease whom has already consented to take part in the research. Supportive individuals cannot take part without an associated individual with Parkinson's Disease having already consented.
* Has regular contact with and is involved in the care and/or support of an individual diagnosed with Idiopathic Parkinson's Disease.
* Able to communicate clearly in English over the telephone/online for over an hour
* Have access to a working computer and internet connection (required for stage 2 only).

C) Healthcare Professionals

* Healthcare Professional with at least 2 years experience of Parkinson's disease treatment/management/clinical care and/or an academic currently working in the area of Parkinson's Disease treatment.
* Have access to a working computer and internet connection (required for stage 2 only).

Exclusion criteria

A) Patients

* Reduced cognition that would preclude active involvement and capacity to consent to participate
* Unable to communicate clearly in English over the telephone/online for over an hour.

B) Partners/Caregivers

* Reduced cognition that would preclude active involvement and capacity to consent to participate
* Unable to communicate clearly in English over the telephone/online for over an hour.

C) Health Care Professional

* Less than 2 years' experience in the treatment/management/clinical care of individuals with Parkinson's disease as determined by self-report
* They have worked in this field but have stopped for two years or more.

Primary outcomes:
measure: Themes related to the views and priorities of lifestyle factors in relation to fatigue and non-motor symptom management in Parkinson's Disease.
timeFrame: Assessed during the interview (60 minutes) after enrollment
measure: Facilitators to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease.
timeFrame: Assessed during the interview (60 minutes) after enrollment
measure: Barriers to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease.
timeFrame: Assessed during the interview (60 minutes) after enrollment
measure: Identified behavioral targets for the intervention as indicated by the mapping of themes onto the COM-B model (capability, opportunity or motivation)
timeFrame: Assessed during the interview (60 minutes) after enrollment
measure: A list of potential methods of intervention delivery, structure and content, ranked in order of preference created during consensus workshops.
timeFrame: From participation in the first consensus session after enrollment until session 2 (around 1-2 weeks later)
Secondary outcomes:
Other outcomes:
measure: Parkinson's Fatigue Scale (PFS-16)
timeFrame: Once prior to the interview and/or consensus workshop.
measure: Becks Depression Inventory (BDI-II)
timeFrame: Once after enrollment, prior to the interview- patients only
measure: Geriatric Anxiety Scale (GAS)
timeFrame: Once after enrollment, prior to the interview- patients only
measure: Apathy Evaluation Scale (AES)
timeFrame: Once after enrollment, prior to the interview- patients only
measure: Parkinson's Disease Sleep Scale (PDSS-2)
timeFrame: Once after enrollment, prior to the interview- patients only.
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
state: Oxfordshire
Study officials:
affiliation: Oxford Brookes University
name: Sophie Lawrie
role: PRINCIPAL_INVESTIGATOR
References: