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

NCT04837976 | Terminated

• 1 other identifier: F.20.09.02
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Fatigue

Keywords

Qualitative; Semi-structured interviews; Thematic analysis; Framework; Nominal Group Technique; Consensus methods

Outcome Measures

Primary Outcomes (5)

• 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)

Other Outcomes (5)

• Parkinson's Fatigue Scale (PFS-16)

  Once prior to the interview and/or consensus workshop.

• Becks Depression Inventory (BDI-II)

  Once after enrollment, prior to the interview- patients only

• Geriatric Anxiety Scale (GAS)

  Once after enrollment, prior to the interview- patients only

Study Arms (3)

Individuals with Parkinson's Disease

Other: Semi-structured interviews and a consensus workshops using nominal group techniques.

Supportive individuals

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.

Healthcare Professionals

Other: Semi-structured interviews and a consensus workshops using nominal group techniques.

Interventions

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.

Healthcare Professionals; Individuals with Parkinson's Disease; Supportive individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford Brookes University: lead

Study Sites (1)

Oxford Brookes University

Oxford, Oxfordshire, OX3 0BP, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie Lawrie

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: May 14, 2021
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)