An observational study in Parkinson Disease and Parkinson, sponsored by University of Southampton. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by University of Southampton · Observational
Background:
People with Parkinson's (PwP) have many symptoms including tremor, stiffness, slow movements, constipation, urinary incontinence and mental health issues. They are often older and have other long-term health conditions. PwP need to do many things to look after their health including manage multiple medications, attend healthcare appointments and lifestyle changes such as improving diet and exercise.
The effort of looking after their health and its impact on them is termed 'treatment burden'. Some PwP need help from their family or friends (caregiver) to complete these tasks. Caregivers may also experience treatment burden themselves when caring for someone with Parkinson's. People's ability to manage treatment burden is termed 'capacity' and is influenced by physical, mental, social and economic factors. People are overburdened when the workload of looking after their health exceeds their capacity. This can lead to poor adherence with treatment, poor quality of life and worse health outcomes.
Aim:
To understand the factors that influence treatment burden and capacity in PwP and caregivers of PwP.
Methods:
Interviews with PwP and caregivers will identify factors that influence treatment burden and capacity. These factors will be explored further in a national survey for PwP and caregivers through Parkinson's UK. The investigators will form focus groups with PwP, caregivers, voluntary sector representatives, healthcare professionals, policy makers and managers through Parkinson's Excellence Networks to discuss and prioritise recommendations for change.
Outcomes:
The investigators will disseminate recommendations of ways to reduce treatment burden and improve future experiences of PwP and caregivers.
This is a mixed-methods study that will be conducted over three work packages as described below and will be completed in 24 months. The investigators will have patient and public involvement throughout the study.
Work Package 1 - Interviews:
The investigators will interview 15-20 PwP and 15-20 caregivers (face-to-face, telephone or video calls) recruited from Parkinson's clinics in Hampshire and Dorset to identify factors that influence treatment burden and capacity among PwP and caregivers of PwP. Participants will be eligible to take part in the study if they have a diagnosis of Parkinson's or is a caregiver for someone with Parkinson's, and able to give informed consent. The investigators will use purposive sampling to include both genders, a range of ages, severity of Parkinson's and caregiver relationships. Potential eligible participants will be identified by the clinical team. Written consent will be obtained prior to each interview. Interviews will be audio-recorded and transcribed. The investigators will take an inductive approach to identify emerging themes until no new information arises.
Work Package 2 - National Survey:
Results from the interviews will then inform the development of a national survey for PwP and caregivers. The national survey will for the first time quantify treatment burden using the Multimorbidity Treatment Burden Questionnaire (MTBQ) and capture aspects of capacity such as severity and duration of Parkinson's, social and economic resources, medications, frailty and health literacy. Participants with mild, moderate and severe Parkinson's will be recruited with agreed support from Parkinson's UK and from Parkinson's clinics. Participants will be eligible to take part in the study if they have a diagnosis of Parkinson's or is a caregiver for someone with Parkinson's, and able to give informed consent. Each participant will be able to complete a separate survey online or on paper.
The investigators will collect the following data from participants:
The investigators will also collect data regarding non-motor symptoms from PwP using the Parkinson's Disease Non-Motor Symptoms Questionnaire.
The investigators will collect the following data from caregivers of PwP: -
Work Package 3 - Focus groups and Dissemination:
Working with Wessex Parkinson's Excellence Network, the investigators will hold two to four focus groups with key stakeholders including PwP, caregivers, voluntary sector representatives, healthcare professionals, policy makers and managers. Participants will be recruited from each local area (Hampshire and Dorset) through Parkinson's clinics, support groups and local services depending on the findings from the interviews and surveys. Each focus group will have 6-10 participants and will be moderated by a member of the research team. Written consent will be obtained from each participant prior to the focus group. Focus groups will be conducted either face-to-face at a neutral location or conducted via video call. Each focus groups will be audio-recorded using a digital recorder with consent and transcribed for further data analysis. The focus groups will discuss the overall study findings and aim to develop and prioritise recommendations of ways to reduce treatment burden and enhance capacity among PwP and their caregivers.
The investigators will then hold a dissemination event to share the outcomes with people affected by Parkinson's with support from Parkinson's UK and the Academic Health Science Networks. The investigators will work closely with Parkinson's UK Excellence Networks to share knowledge and implement changes that improve treatment burden and enhance capacity among PwP and caregivers. The findings will be disseminated through publications in peer-reviewed journals and presentations at regional and national conferences.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 188 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Southampton is the lead sponsor of 121 studies on the registry; 19 are open to participants now.
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For Work Packages 1 and 2-
Inclusion Criteria:
Exclusion Criteria:
For Work Package 3:
Inclusion Criteria:
Exclusion criteria:
Work Package 1: Interviews with 15-20 people with Parkinson's and 15-20 caregivers. Work Package 2: National Survey with up to 2000 participants Work Package 3: Two to four Focus Groups with key stakeholders (6-10 participants per focus group)
Treatment Burden Experiences
The investigators will describe the key factors that influence participants' experiences of treatment burden
Time frame: 24 months
Capacity
The investigators will describe the key factors that influence participants' capacity
Time frame: 24 months
Treatment Burden Levels
Treatment burden levels will be measured using the Multimorbidity Treatment Burden Questionnaire (MTBQ):- Overall scores (0-100) categorised as no burden (score 0), low burden (score \<10), medium burden (10-22) and high burden (\>=22).
Time frame: 24 months
Multimorbidity and treatment burden levels
Multimorbidity assessed with self-reported number of co-morbidities
Time frame: 24 months
Frailty and treatment burden levels
Frailty assessed using the Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7) screening tool; Score of ≥3 defined as frail
Time frame: 24 months
Severity of Parkinson's and treatment burden levels
Severity Parkinson's will be measured using the self-reported Hoehn and Yahr scale (0-5) 0 - No sign of disease 1. - Unilateral involvement 2. - Bilateral involvement without impairment of balance 3. - Mild to moderate bilateral disease; some postural instability; physically independent 4. - Severe disability; still able to walk or stand unassisted 5. - Wheelchair bound or bedridden unless aided
Time frame: 24 months
Plan to share: Yes — Anonymised study data will be made available upon request.
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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