Treatment Burden in Parkinson's

NCT04769973 | Completed

• 2 other identifiers: 62623277464
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease; Parkinson

Keywords

Treatment Burden; Burden of Treatment

Outcome Measures

Primary Outcomes (3)

• Treatment Burden Experiences

  The investigators will describe the key factors that influence participants' experiences of treatment burden

  24 months

• Capacity

  The investigators will describe the key factors that influence participants' capacity

  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).

  24 months

Secondary Outcomes (3)

• Multimorbidity and treatment burden levels

  24 months

• Frailty and treatment burden levels

  24 months

• Severity of Parkinson's and treatment burden levels

  24 months

Study Arms (1)

Work Packages 1 - 3

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)

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

1. Participants for the interviews will be purposively sampled from Parkinson's clinics in Hampshire and Dorset. 2. Participants for the national survey will be recruited from Parkinson's clinics in Hampshire and Dorset as well as through Parkinson's UK Research Support Network and Take Part Hub. 3. Participants for the focus groups will be recruited from Parkinson's clinics in Hampshire and Dorset as well as working with Wessex Parkinson's Excellence Network

You may qualify if:

• People diagnosed with Parkinson's or caregiver of someone diagnosed with Parkinson's
• Able to consent to participate

You may not qualify if:

• \. Unable to consent to participate
• For Work Package 3:
• Have a role in the care of someone with Parkinson's including but not limited to people diagnosed with Parkinson's, caregiver of someone with diagnosed with Parkinson's, healthcare professionals, volunteer sector representative, policy maker or manager
• Able to consent to participate.
• \. Unable to consent to participate

Sponsors & Collaborators

• University of Southampton: lead
• Southern Health NHS Foundation Trust: collaborator
• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Christchurch Hospital, University Hospitals Dorset NHS Foundation Trust

Bournemouth, Dorset, Bh23 2JX, United Kingdom

Location

Romsey Hospital, Southern Health NHS Foundation Trust

Southampton, Hampshire, SO51 7ZA, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Qian Yue Tan

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 25, 2021
• Study Start: June 22, 2021
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The investigators will preserve all study data and keep it available for sharing within the science community for up to 10 years. This timeframe is consistent with the investigators' local university policy.
• Access Criteria: Requests for access to anonymised data by other researchers can be submitted by contacting the Principle Investigator. All requests will be carefully considered by the research team.

Locations

GB (2)