Parkinson DiseaseNCT04837976
Lifestyle and Non-motor Symptom Management in Parkinson's Disease
An observational study of Parkinson Disease and Fatigue, run by Oxford Brookes University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Fatigue
- What is being tested?
- Semi-structured interviews and a consensus workshops using nominal group techniques.
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 May 2021to 7 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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).
- 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).
Who cannot join
- 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.
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Brookes University
Oxford, Oxfordshire, OX3 0BP
About this study
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
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.
Read the 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:
- Semi-structured interviews (lasting around 60 minutes)
- 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.
- Conditions
- Parkinson Disease, Fatigue
- Being tested
- Semi-structured interviews and a consensus workshops using nominal group techniques.
- Keywords
- Qualitative, Semi-structured interviews, Thematic analysis, Framework, Nominal Group Technique, Consensus methods
- Medical subject headings
- Parkinson Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Parkinson's Disease | Not described Receives: 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. Receives: Other: Semi-structured interviews and a consensus workshops using nominal group techniques. | |
| Healthcare Professionals | Not described Receives: Other: Semi-structured interviews and a consensus workshops using nominal group techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes related to the views and priorities of lifestyle factors in relation to fatigue and non-motor symptom management in Parkinson's Disease.
Measured: Assessed during the interview (60 minutes) after enrollment
Facilitators to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease.
Measured: Assessed during the interview (60 minutes) after enrollment
Barriers to dietary and exercise-based lifestyle change amongst patients with Parkinson's disease.
Measured: 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)
Measured: 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.
Measured: From participation in the first consensus session after enrollment until session 2 (around 1-2 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start14 May 2021
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Lawrie, Oxford Brookes University
- Investigators
- Sophie Lawrie, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837976
- Sponsor's protocol ID
- F.20.09.02
- Status last verified
- Feb 2022
- First submitted
- 6 Apr 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04837976
- Acronym / sponsor ID
- F.20.09.02
- Conditions
- Parkinson Disease, Fatigue
- Keywords
- Qualitative, Semi-structured interviews, Thematic analysis, Framework, Nominal Group Technique, Consensus methods
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Semi-structured interviews (lasting around 60 minutes)
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals with Parkinson's Disease | – | Other: Semi-structured interviews and a consensus workshops using nominal group techniques. |
| Supportive individuals | – | 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. |
| Healthcare Professionals | – | Other: Semi-structured interviews and a consensus workshops using nominal group techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
- Partners/Caregivers
- Reduced cognition that would preclude active involvement and capacity to consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthcare Professionals, Individuals with Parkinson's Disease, Supportive individuals |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Lawrie principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Fatigue, run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.