Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837976
Status:
TERMINATED
Last Update Posted:
2022-03-11
First Post:
2021-04-06
Brief Title:
Lifestyle and Non-motor Symptom Management in Parkinsons Disease
Sponsor:
Oxford Brookes University
Organization:
Oxford Brookes University
Study Overview
Official Title:
Views and Priorities of Lifestyle Factors in the Management of Non-motor Symptoms in Parkinsons Disease Qualitative Interviews and Consensus Workshops With Patients Caregivers and Healthcare Professionals
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parkinsons 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 Parkinsons 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 HCPs 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 partnerscaregivers and Healthcare professionals will be able to participate in interviews only workshops only or both The interviews will investigate patients partnerscaregivers and Healthcare Professionals views and priorities of lifestyle factors in the management of non-motor symptoms in Parkinsons 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 Parkinsons Disease
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 HCPs 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 partnerscaregivers and Healthcare professionals will be able to participate in interviews only workshops only or both The interviews will investigate patients partnerscaregivers and Healthcare Professionals views and priorities of lifestyle factors in the management of non-motor symptoms in Parkinsons 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 Parkinsons Disease
Detailed Description:
Global aim To assess stakeholders patients supportive individuals and HCPs views and priorities of lifestyle factors in the management of fatigue and related non-motor symptoms in Parkinsons 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 Parkinsons Disease supportive individuals partnerscaregiversfamily memberssignificant 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
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 Parkinsons Disease supportive individuals partnerscaregiversfamily memberssignificant 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None