Parkinson DiseaseOPTIMPARK1NCT04125485
The Optimisation of Parkinson's Project
An observational study of Parkinson Disease, run by University of Southampton at 1 site in United Kingdom.
Trial summary
This project aims to gain a deep understanding of the available lay/professional community resources and systems of support for people with, and family carers of people with Parkinson's Disease (PD), healthcare professionals and organisations and community groups, and discuss strategies that could approximate… 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
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2019to 1 Sep 2022
- 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: This project aims to gain a deep understanding of the available lay/professional community resources and systems of support for people with, and family carers of people with PD, and organisations and community groups, and discuss strategies that could approximate interests of voluntary groups, and patients and families. This will constitute a starting point to propose a transformative framework that incorporates dialogue between sectors and levels of care for better living with PD.
Who may be able to join
- Person with Parkinson's (PD)
- People with PD living at home,
- Hoehn \& Yahr stage 1-4 (Hoehn and Yahr, 1967),
- Cognitively able to participate,
- Able to speak a conversational level of English,
- Different stages of PD (early, mid, later by years of diagnosis)
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- Ages - younger and older.
- People with PD do not need to have their carer involved in the study also and vice-versa.
- Family carer
- Family caregivers of PD patients at different stages (early, mid, late) or friends involved in the care process.
- Family caregivers of patients with cognitive impairment will be included.
- Family carers do not need to have the person they care for in the study also and vice-versa.
- Stakeholders:
- Non-NHS professionals or volunteers involved in policy making or working or collaborating in voluntary organisations or from different sectors; (non-NHS) Health Care, Social Services, voluntary sector, employment, food, Pharmaceutical, Education, Political, that have an impact directly or indirectly in the management of PD and development of care pathways for PD or other long-term conditions (when relevant).
- Healthcare professional
- From a range of different disciplines (physician, neurologist, General Practitioners nurses/specialist nurses, social worker, occupational therapist, mental health workers, physiotherapist, pharmacist, speech therapist) that provide support directly or indirectly to patients with PD and family carers.
Who cannot join
- Person with Parkinson's (PD)
- Any hospital admission within the last 1 year, whether for PD or anything else, that was for more than 24 hours i.e. not day surgery/brief checks in the emergency department after falls;
- Patients diagnosed with PD less than 6 months ago to confirm the diagnosis and allowed them to have time for using the resources for people with PD
- Unwillingness to participate.
- Family carer
- Not being directly involved in the care of the person with PD
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- Unwillingness to participate in the project
- An ability to speak a conversational level of the English language.
- Stakeholder
- Unwillingness to participate in the project
- Lack of involvement in strategic planning or involvement in provision of community PD care
- Healthcare professional
- Not involved in direct care or support of people with PD
- Unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton
Southampton, Hampshire, SO17 1BJ
About this study
Official title: The Optimisation of Parkinson's Project (OPTIMPARK) 1: Personal Networks and Community Resources and the Process of Living With Parkinson's - NHS
This project aims to gain a deep understanding of the available lay/professional community resources and systems of support for people with, and family carers of people with Parkinson's Disease (PD), healthcare professionals and organisations and community groups, and discuss strategies that could approximate interests of voluntary groups, and patients and families. This will constitute a starting point to propose a transformative framework that incorporates dialogue between sectors and levels of care for better living with PD.
Read the detailed description
From previous research the investigators know that living with PD depends on several factors including the acceptance of diagnosis of PD management of symptoms and social support for the person with the condition. Through this project the investigators aim to map on a diagram (using a method called concentric circles) what are the lay and professional community resources and systems of support that people with PD use or have available to them in the community. The investigators will also explore ways these resources can be better utilized, and to discuss their personal social preferences. This project aims to gain a deep understanding of these resources and systems of support for people living with PD in the community, carers, stakeholders and healthcare professionals, and discuss strategies that could approximate interests of all stakeholders and professionals. This will constitute a starting point to develop and implement a transformative framework that incorporates dialogue between sectors and levels of care for better living with PD.
The investigators plan to look at knowledge and attitudes towards resources in the community of people with PD carers, stakeholders and healthcare professionals, with a special interest in those living in less advantaged circumstances, such as older people living alone or in less accessible areas. The investigators will map the social support available on circle diagrams (demonstrating varying levels of value of this support) in one-to-one interviews with approximately 10 people with PD, 10 family carers, 10 Stakeholders and 10 healthcare professionals. The investigators will also undertake Focus Groups (n=4) with each of these stakeholder groups. Focus Groups will go over concepts raised in interviews and develop further understanding of priorities and tensions between different stakeholder groups.
Participants will take part in semi-structured interviews, which will begin with using a concentric circles diagram to discuss and map social support networks and availability of support for people with PD and family carers from the perspective of people with PD, carers, stakeholders and healthcare professionals. This will encompass identification and discussion of existing community resources and systems of support. All participants will also be asked to complete a socio-demographic form (e.g. ge, gender, years since diagnosis of PD, working status or organisation and professional role and years in practice).
Individual interviews will be undertaken face-to-face or by phone and will follow a semi-structured interview guide. The mapping element creates a visual map of participant's current social and support network, applying a concentric circles method, which will involve thinking of, and visualising the sources of support or community resources involved in their life as person with PD, carer, community or professional stakeholder or Healthcare professional. Furthermore, participants' social preferences or choices will be discussed in an attempt to understand the potential changes experienced and the utility and appropriateness of community resources.
This process will be facilitated and discussion will take place with the participant.
Participants will be invited to take part in a Focus Group following on from analysis of interviews to go over concepts raised in interviews and develop further understanding of priorities and tensions between different stakeholder groups.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Person with Parkinson's | Inclusion criteria for interview/focus group with people with PD: people with PD living at home, Hoehn \& Yahr stage 1-4 (Hoehn and Yahr, 1967), cognitively able to participate, able to speak a conversational level of English, and at different stages of PD (early, mid, later by years of diagnosis) and ages (younger and older). Exclusion criteria: any hospital admission within the last 1 year, whether for Parkinson's or anything else, that was for more than 24 hours i.e. not day surgery/brief checks in the emergency department after falls; patients diagnosed with PD less than 6 months ago to confirm the diagnosis and allowed them to have time for using the resources for people with PD; unwillingness to participate. | |
| Healthcare professional | Inclusion criteria for interview/focus group for health professionals: Professionals from different disciplines (physician, neurologist, General Practitioners, nurses/specialist nurses, social worker, occupational therapist, mental health workers, physiotherapist, pharmacist, speech therapist) that provide support directly or indirectly to patients with PD and family carers. Exclusion criteria: Not involved in direct care or support of people with PD or unwillingness to participate. | |
| Family carer | Inclusion and exclusion criteria for all are the same for Interviews and Focus Groups. Family carers: Inclusion criteria: family caregivers of PD patients at different stages (early, mid, late) or friends involved in the care process. Also, family caregivers of patients with cognitive impairment will be included. Exclusion criteria: not being involved in the care of the person with PD or unwillingness to participate in the project, and an ability to speak a conversational level of the English language. Family carers do not need to have the person they care for in the study also and vice-versa. | |
| Stakeholder | Stakeholders: Inclusion criteria: non-NHS professionals or volunteers involved in policy making or working or collaborating in voluntary organisations or from different sectors; (non-NHS) Health Care, Social Services, voluntary sector, employment, food, Pharmaceutical, Education, Political, that have an impact directly or indirectly in the management of PD and development of care pathways for PD or other long-term conditions (when relevant). Exclusion criteria: unwillingness to participate in the project or lack of involvement in strategic planning or involvement in provision of community PD care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interviews and qualitative Focus Groups
We are not using questionnaires or other quantitative outcomes measures in this study, which is a development stage for a future feasibility study. We are using one-to-one qualitative interviews (10 of each participant group) and qualitative Focus groups (x4), and will use an interview schedule which will cover the following;
- knowledge, attitudes and perceptions about the available resources and support for people with PD
- the community challenges (availability of resources, integration of services, support in care) and the factors that influence roles, working relationships and partnerships between sectors in the management of PD.
- use a concentric circles mapping network tool to map out the sources of support in the community.
- strategies that could build partnerships between all stakeholders for development of a multi-sectoral action plan.
- the relationships with and capacity of voluntary organisations and their role in enhancing the experience of living with PD.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start11 Jun 2019
- Primary completion30 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mari Carmen Portillo, PhD,MSc,RN, Study chair, University of SouthamptonHelen Roberts, PhD,FRCP,MB, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125485
- Sponsor's protocol ID
- 48708
- Acronym
- OPTIMPARK1
- Status last verified
- Oct 2021
- First submitted
- 19 Aug 2019
- Last updated
- 8 Oct 2021
- 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 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimisation of Parkinson's Project (OPTIMPARK) 1: Personal Networks and Community Resources and the Process of Living With Parkinson's - NHS
- ClinicalTrials.gov ID
- NCT04125485
- Acronym / sponsor ID
- OPTIMPARK1 / 48708
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 14 Oct 2019 (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.
This project aims to gain a deep understanding of the available lay/professional community resources and systems of support for people with, and family carers of people with Parkinson's Disease (PD), healthcare professionals and organisations and community groups, and discuss strategies that could approximate interests of voluntary groups, and patients and families. This will constitute a starting point to propose a transformative framework that incorporates dialogue between sectors and levels of care for better living with PD.
Detailed description
From previous research the investigators know that living with PD depends on several factors including the acceptance of diagnosis of PD management of symptoms and social support for the person with the condition. Through this project the investigators aim to map on a diagram (using a method called concentric circles) what are the lay and professional community resources and systems of support that people with PD use or have available to them in the community. The investigators will also explore ways these resources can be better utilized, and to discuss their personal social preferences. This project aims to gain a deep understanding of these resources and systems of support for people living with PD in the community, carers, stakeholders and healthcare professionals, and discuss strategies that could approximate interests of all stakeholders and professionals. This will constitute a starting point to develop and implement a transformative framework that incorporates dialogue between sectors and levels of care for better living with PD.
The investigators plan to look at knowledge and attitudes towards resources in the community of people with PD carers, stakeholders and healthcare professionals, with a special interest in those living in less advantaged circumstances, such as older people living alone or in less accessible areas. The investigators will map the social support available on circle diagrams (demonstrating varying levels of value of this support) in one-to-one interviews with approximately 10 people with PD, 10 family carers, 10 Stakeholders and 10 healthcare professionals. The investigators will also undertake Focus Groups (n=4) with each of these stakeholder groups. Focus Groups will go over concepts raised in interviews and develop further understanding of priorities and tensions between different stakeholder groups.
Participants will take part in semi-structured interviews, which will begin with using a concentric circles diagram to discuss and map social support networks and availability of support for people with PD and family carers from the perspective of people with PD, carers, stakeholders and healthcare professionals. This will encompass identification and discussion of existing community resources and systems of support. All participants will also be asked to complete a socio-demographic form (e.g. ge, gender, years since diagnosis of PD, working status or organisation and professional role and years in practice).
Individual interviews will be undertaken face-to-face or by phone and will follow a semi-structured interview guide. The mapping element creates a visual map of participant's current social and support network, applying a concentric circles method, which will involve thinking of, and visualising the sources of support or community resources involved in their life as person with PD, carer, community or professional stakeholder or Healthcare professional. Furthermore, participants' social preferences or choices will be discussed in an attempt to understand the potential changes experienced and the utility and appropriateness of community resources.
This process will be facilitated and discussion will take place with the participant.
Participants will be invited to take part in a Focus Group following on from analysis of interviews to go over concepts raised in interviews and develop further understanding of priorities and tensions between different stakeholder groups.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Person with Parkinson's | – | –Inclusion criteria for interview/focus group with people with PD: people with PD living at home, Hoehn \& Yahr stage 1-4 (Hoehn and Yahr, 1967), cognitively able to participate, able to speak a conversational level of English, and at different stages of PD (early, mid, later by years of diagnosis) and ages (younger and older). Exclusion criteria: any hospital admission within the last 1 year, whether for Parkinson's or anything else, that was for more than 24 hours i.e. not day surgery/brief checks in the emergency department after falls; patients diagnosed with PD less than 6 months ago to confirm the diagnosis and allowed them to have time for using the resources for people with PD; unwillingness to participate. |
| Healthcare professional | – | –Inclusion criteria for interview/focus group for health professionals: Professionals from different disciplines (physician, neurologist, General Practitioners, nurses/specialist nurses, social worker, occupational therapist, mental health workers, physiotherapist, pharmacist, speech therapist) that provide support directly or indirectly to patients with PD and family carers. Exclusion criteria: Not involved in direct care or support of people with PD or unwillingness to participate. |
| Family carer | – | –Inclusion and exclusion criteria for all are the same for Interviews and Focus Groups. Family carers: Inclusion criteria: family caregivers of PD patients at different stages (early, mid, late) or friends involved in the care process. Also, family caregivers of patients with cognitive impairment will be included. Exclusion criteria: not being involved in the care of the person with PD or unwillingness to participate in the project, and an ability to speak a conversational level of the English language. Family carers do not need to have the person they care for in the study also and vice-versa. |
| Stakeholder | – | –Stakeholders: Inclusion criteria: non-NHS professionals or volunteers involved in policy making or working or collaborating in voluntary organisations or from different sectors; (non-NHS) Health Care, Social Services, voluntary sector, employment, food, Pharmaceutical, Education, Political, that have an impact directly or indirectly in the management of PD and development of care pathways for PD or other long-term conditions (when relevant). Exclusion criteria: unwillingness to participate in the project or lack of involvement in strategic planning or involvement in provision of community PD care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This project aims to gain a deep understanding of the available lay/professional community resources and systems of support for people with, and family carers of people with PD, and organisations and community groups, and discuss strategies that could approximate interests of voluntary groups, and patients and families. This will constitute a starting point to propose a transformative framework that incorporates dialogue between sectors and levels of care for better living with PD.
Key inclusion criteria (16 listed)
- Person with Parkinson's (PD)
- People with PD living at home,
- Hoehn \& Yahr stage 1-4 (Hoehn and Yahr, 1967),
- Cognitively able to participate,
- Able to speak a conversational level of English,
Key exclusion criteria (14 listed)
- Person with Parkinson's (PD)
- Any hospital admission within the last 1 year, whether for PD or anything else, that was for more than 24 hours i.e. not day surgery/brief checks in the emergency department after falls;
- Patients diagnosed with PD less than 6 months ago to confirm the diagnosis and allowed them to have time for using the resources for people with PD
- Unwillingness to participate.
- Family carer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative interviews and qualitative Focus Groups
Time frame: Through study completion, an average of 6 months
We are not using questionnaires or other quantitative outcomes measures in this study, which is a development stage for a future feasibility study. We are using one-to-one qualitative interviews (10 of each participant group) and qualitative Focus groups (x4), and will use an interview schedule which will cover the following; * knowledge, attitudes and perceptions about the available resources and support for people with PD * the community challenges (availability of resources, integration of services, support in care) and the factors that influence roles, working relationships and partnerships between sectors in the management of PD. * use a concentric circles mapping network tool to map out the sources of support in the community. * strategies that could build partnerships between all stakeholders for development of a multi-sectoral action plan. * the relationships with and capacity of voluntary organisations and their role in enhancing the experience of living with PD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- 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.
Mari Carmen Portillo, PhD,MSc,RN study chair
University of Southampton
Helen Roberts, PhD,FRCP,MB principal investigator
University of Southampton
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, run by University of Southampton 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 16 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 8 Oct 2021. 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?
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?
Qualitative interviews and qualitative Focus Groups (time frame: Through study completion, an average of 6 months). 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 8 Oct 2021.