Live well with Parkinson's
| ISRCTN | ISRCTN92831552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92831552 |
| IRAS number | 294372 |
| Secondary identifying numbers | CPMS 50058, IRAS 294372 |
- Submission date
- 04/10/2021
- Registration date
- 26/10/2021
- Last edited
- 28/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Parkinson's disease (PD) is a progressive brain disorder that affects approximately 127,000 people in the UK. People have increasing difficulty with movement and many other problems including falls, bladder and bowel disturbance, low mood and anxiety, fatigue and sleep disturbance, pain and impaired memory. This can lead to increasing disability, reduced quality of life and unplanned hospital admissions. Management is often complex and management guidelines exist, but access to specialised care is often limited.
Increasingly, patient or carer participation in management (i.e., self-management) is incorporated into health care for long-term conditions (LTCs), as this can allow people to take control and improve outcomes in the face of restricted resources and fragmentation of health care. Currently, no self-management toolkit for people with Parkinson’s exists for the public.
This study aims to improve the health and well-being of people with Parkinson's by testing the effectiveness of the ‘Live Well with Parkinson’s’ Toolkit compared to usual care in a clinical trial. This study will test if the toolkit works in this and also whether it is cost-effective to be used in the NHS.
Who can participate?
Any person with a diagnosis of Parkinson’s disease, that lives at home can participate.
What does the study involve?
The toolkit is available online and in paper and aims to help increase the active involvement of people with Parkinson’s in the management of their care, including how to keep healthy and independent, where to access resources and how to manage their Parkinson’s. The toolkit is facilitated by a ‘Supporter’ who will offer up to six one-to-one sessions with the participants in which they will be directed to relevant information and advice on symptoms that may be bothering them as well as identifying what living well means to them and what steps they can take to achieve this.
What are the possible benefits and risks of participating?
It is hoped that the Live Well with Parkinson’s toolkit will reduce disability and hospital admissions and improve day-to-day living and quality of life. No specific risks have been identified.
Where is the study run from?
The study team is based at the Royal Free London NHS Trust and UCL (UK)
When is the study starting and how long is it expected to run for?
July 2021 to August 2024
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
rf.livewellparkinsons@nhs.net
Contact information
Scientific
University College London
Research Department of Primary Care & Population Health
Royal Free Campus
Rowland Hill St
London
NW3 2PF
United Kingdom
| Phone | +442031087812 |
|---|---|
| kumud.kantilal@ucl.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | 40508 PIS V1.1 01Sep21.pdf |
| Scientific title | Live Well with Parkinson’s (part of the program: personalised care for people with Parkinson’s Disease: PD-Care WP4) |
| Study acronym | PD-Care WP4 |
| Study hypothesis | The study's main objective is to evaluate whether the “Live Well with Parkinson’s” facilitated self-management toolkit enables personalised care, reduces disability and preventable hospital admissions, and improves quality of life for community-living people with Parkinson’s. |
| Ethics approval(s) |
Approved 18/10/2021, London – Harrow REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom; +44(0)207 104 8356; harrow.rec@hra.nhs.uk), ref: 21/LO/0562 |
| Condition | Parkinson's Disease |
| Intervention | The intervention consists of access to the ‘Live well with Parkinson’s’ toolkit (either online or paper format) and supporter sessions. The toolkit was co-designed with people with Parkinson’s, carers, health and social care professionals and Parkinson’s disease experts. It is based on evidence from effective health promotion interventions and incorporates theory-based behaviour change techniques. The research team conducted two systematic reviews synthesising evidence on self-management techniques for people with Parkinson’s and explored the barriers and facilitators of using them. These reviews were supplemented with interviews with people with Parkinson’s, carers, and health care professionals to explore the challenges people with Parkinson’s and those that support them face. Combining this evidence with a series of co-design workshops and user testing led to the development of the toolkit of potential strategies, drawing on theory and evidence-based techniques, to help overcome the challenges people with Parkinson’s face and to support them to live independently. The key theories the toolkit draws upon are: 1) Person-centred care: working in partnership with the participant to develop a plan to address their needs or priorities. 2) Self-management: teaching participants to actively identify challenges and solve problems associated with their illness themselves with support. 3) Behaviour change model: This suggests that all behaviours depend on the presence of three core determinants: capability, opportunity, and motivation. Therefore, any changes the participant would like to make to their behaviour must incorporate those three components. 4) Asset based approached: By encouraging participants to focus on their assets (i.e., what they enjoy and can do) as opposed to their deficits (i.e., what they can’t do) may encourage some to maintain the positive behaviours. The toolkit consists of 64 information sections on what Parkinson’s is, symptoms, therapies/treatments, optimising wellbeing, and practical advice which were identified as important in co-design with people affected by Parkinson’s and experts in the area. Each content section has been through review by two members of the team, an expert in the specific area and by PPI team members, and subject to ‘readability’ review. The toolkit also comprises personalised sections on the following: • About Me – including information on their contracts, support and planning future care. • My Health – including information on their health conditions, medication, treatments, and research involvement. • Symptom Review – a list of symptoms they experience and the severity of them. This will allow the participants to identify and explore the symptoms they are experiencing. • My Wellbeing – to identify health behaviours they would like to maintain or improve. • My Tracker – to track medications, activities, and symptoms. This section allows participants to identify patterns and specialists to get a better idea of what participants are experiencing. • Appointments/calendar - In our co-design process, participants asked for a calendar within the toolkit, so that all their healthcare appointments could be stored in one place. • To do lists/Notes – a way to note or list anything that participants feel is useful. Both the paper and online version can be shared with participants’ carers and HCPs if they wish. Participants can share the whole toolkit or select sections. Intervention supporter sessions. Participants, and, if the participants would like, the carer, will receive around four (up to six if needed) sessions over six months led by a ‘supporter’. The supporter will be a trained professional with a background in healthcare (e.g.psychology, occupational therapy, nursing), social care or third sector (e.g. care navigation, social prescribing) with some experience of working/caring for people with Parkinson’s and will receive training to deliver the intervention. The sessions will be around 60-90 minutes for the first two sessions and around 30 minutes for the remaining sessions. The aim of the sessions is to encourage the participants to self-manage their condition by using the ‘Live well with Parkinson’s’ toolkit. The supporter will follow a manual and checklists covering support navigating the toolkit, understanding the benefits of using the different sections and assist in the creation of wellbeing priorities (goals) and use behaviour change techniques to help implement priorities long-term. These sessions will be conducted online via Zoom, by telephone or face-to-face when appropriate. Randomization: Participants will be randomised by PRIMENT CTU (using web-based service, 'Sealed Envelope') in a 1:1 ratio to the intervention or treatment as usual (TAU) group: (1) Intervention: TAU (see below) plus access to ‘Live well with Parkinson’s’ toolkit, supported by trained service providers or (2) TAU: usual care from existing sources (GP, Parkinson’s specialist service +/- NHS PDNS). Treatment as usual in the current NHS, is delivered by primary care together with secondary care (neurology and geriatrics) consultations every six to 12 months, with a PDNS who provides information, reviews and a telephone service for queries between appointments. Referrals to other specialities, therapists (physiotherapy, occupational therapy, speech and language therapy, social care services etc) are made as appropriate. Participants will be assessed remotely or face-to-face at baseline and 6 and 12 months. Assessors will be blind to treatment group. Outcome measurements have been chosen to capture important domains that might change with the intervention, including potential mechanisms (e.g., self-efficacy), using the best valid and reliable measures available, with shorter instruments chosen where possible to reduce participant burden. The outcome assessments will take approximately 90 minutes to complete, which based on previous studies in similar populations is an acceptable length. Ancillary Studies Participants will be given the opportunity to donate a saliva sample for genetic analysis for use in future research unrelated to the aims of the current study. In addition, in order to assess changes in motor function better, electronic measurements, which have been proposed as more accurate than clinical judgment on rating scales, are included as optional assessments: A wearable movement sensor, which is being used in the UK Biobank study (Axivity; https://axivity.com/) and other clinical trials in the UK (https://axivity.com/case-studies/interval), to be worn at the trunk (e.g. on the belt) will be provided and worn for 7 days after assessment. Internal pilot The first six months of recruitment (n=80) will form an internal pilot with stop/go criteria, to test trial recruitment procedures and participant willingness to be randomised. The stop/go progression criteria at 6 months are the following: 1. Minimum recruitment and randomisation rate of 70% of the target of 80 people within 6 months (10 people per month for first 2 months during set-up phase, followed by 20 per month for 4 months). 2. Minimum uptake of the intervention of 70% of participants (evidence of use of the toolkit/attendance at follow-up appointments). 3. Minimum retention rate of 70% at 6 months (completion of main outcome measures). 4. No serious intervention-related adverse events. If the trial is successful in meeting these criteria the full RCT will proceed, and data from the pilot phase contribute to the outcomes. Recruitment rate and attrition will be monitored very closely and if levels are less than expected contingency measures will be put in place (e.g. expand to further study sites, introduce incentives). |
| Intervention type | Other |
| Primary outcome measure | Quality of life measured using the Parkinson's Disease Questionnaire (PDQ-39) at baseline, 6 and 12 months |
| Secondary outcome measures | All measured at baseline, 6 and 12 months: From people with Parkinson’s: 1. Non-motor Parkinson’s symptoms measured using Movement Disorders Society - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part I and II (Mentation, Behaviour, Mood and ADL). 2. Motor Parkinson’s symptoms measured using MDS-UPDRS part 3 (motor), part 4 (motor-complications including Off-time) and total score 3. Non-motor Parkinson’s symptoms measured using Non-Motor Symptoms Scale (NMSS, 30 items) 4. Quality of life measured using EQ-5D-5L: Quality of life (5 items and visual analogue scale) 5. GHQ12: Psychological well-being (12 items) 6. Valuation of Informal Care measured using Client Service Receipt Inventory-shortened, adapted for Parkinson’s from iMTA Valuation of Informal Care Questionnaire (iVICQ), Health/social care resources, out of pocket costs, financial impact on carers, welfare payments and living arrangements 7. Self-Efficacy for Managing Chronic Disease (6- Item Scale) 8. ICECAP-O: capability (5 items) 9. Patient activation measured using Patient Activation Measure (PAM) 10. Medication, deaths measured using patient records 11. Cognition measured using MoCA at baseline only. Health economic evaluation will include incremental cost per quality-adjusted and capability-adjusted life year gained from i) health/social care perspective and ii) societal perspective and a decision-analytic model extrapolating costs/consequence beyond the trial. From carers: 11. Carer burden measured using Zarit carer burden inventory (22 items) 12. Carer quality of life measured using Carer Quality of Life questionnaire for Parkinsonism (26 items) |
| Overall study start date | 05/07/2021 |
| Overall study end date | 31/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 338; UK Sample Size: 338 |
| Total final enrolment | 346 |
| Participant inclusion criteria | Community-dwelling adults with a confirmed diagnosis of Parkinson’s Disease, (defined using UK Brain Bank Criteria), including those with dementia diagnosed at least 1 year after Parkinson's diagnosis |
| Participant exclusion criteria | 1. Atypical Parkinsonism 2. Currently an inpatient or living in a care home 3. Life expectancy <6 months |
| Recruitment start date | 01/11/2021 |
| Recruitment end date | 06/06/2023 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
London
NW3 2QG
United Kingdom
Lewsey Rd
Luton
LU4 0DZ
United Kingdom
London
SE13 6LH
United Kingdom
Hertfordshire
Stevenage
SG1 4AB
United Kingdom
London
SE5 9RS
United Kingdom
Prittlewell Chase
Westcliff-on-sea
SS0 0RY
United Kingdom
London
E9 6SR
United Kingdom
250 Euston Road
London
NW1 2PG
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
| Phone | +44 207 7940500 |
|---|---|
| rf.randd@nhs.net | |
| Website | http://www.royalfree.nhs.uk/ |
"ROR" |
https://ror.org/04rtdp853 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This stage aims to maximise implementation, and includes development of training materials/user guides, policy briefing documents, commissioning costing models and engagement with stakeholders. Implementation: a) Website, user guides, training manuals b) Briefing documents, costing model (policy/commissioners), protecting IP c) Stakeholder symposium Dissemination: This research will provide a novel tool to enable people with Parkinson’s to take active control of the management of their Parkinson’s symptoms, and enable patient-led, personalised and evidence-based interaction with health professionals. At the end of this project a theoretically informed, evidence-based supported self-management intervention with data on effectiveness and cost-effectiveness, will be ready for roll out across the NHS. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from PRIMENT CTU Data Management Group on priment@ucl.ac.uk and will only be possible in collaboration with members of the PD-Care Trial Management Group, pd-care@ucl.ac.uk. The data underlying this study contains sensitive information and cannot be made publicly available, according to PRIMENT CTU Data Management Group. PRIMENT CTU is a UK Clinical Research Collaboration (UKCRC) registered clinical trials unit and is based at UCL (see here for more information: https://www.ucl.ac.uk/priment). The study collects quantitative data from patient assessments as well as interview data, which will become available after data processing and cleaning, a week as initial analysis at the end of the study. It will be made available to bona fide researchers upon reasonable request, observing data protection rules. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 01/09/2021 | 21/10/2021 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 05/12/2023 | 07/12/2023 | Yes | No | |
| Statistical Analysis Plan | version 1.3 | 26/11/2024 | No | No | |
| Protocol file | version 1.4 | 23/03/2023 | 28/11/2024 | No | No |
Additional files
Editorial Notes
28/11/2024: Uploaded protocol (not peer-reviewed) as an additional file.
26/11/2024: Statistical analysis plan uploaded.
07/12/2023: Publication reference added.
15/09/2023: The following changes were made:
1. The scientific contact was changed.
2. The overall study end date was changed from 31/08/2023 to 31/08/2024 and the plain English summary updated accordingly.
3. The total final enrolment number was added.
4. The recruitment end date was changed from 01/05/2023 to 06/06/2023.
5. The intention to publish date was changed from 01/08/2024 to 01/03/2025.
03/10/2022: The following changes were made to the trial record:
1. The contact was changed.
2. The participant level data statement was added.
04/10/2021: Trial's existence confirmed by the NIHR.
