OPTIM-PARK II -A New Intervention for Optimisation of Community Resources and Systems of Support to Enhance the Process of Living With Parkinson's Disease: a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 4
- 主要终点
- Resources used in the community (assessing change)
研究概览
简要总结
This is a multi-centre, single-blinded, randomized, controlled trial for PwPD (people with Parkinson's Disease) to compare (i) OPTIM-PARK II (a novel personalized treatment based on the latest published research evidence and results from our extensive development work undertaken in OPTIM-PARK I) and routine care with (ii) routine care alone. The research team will provide a personalized list of available resources to the routine care arm at the end of the trial. The trial aims to recruit 60 PwPD and their carers (n=60) in the UK. This trial took place in 4 countries (Denmark, Norway, Spain and UK) but only Spain and UK included control groups, data collection in these two countries started in October 2022, after the iterative phase of the trial.
At the screening visit participants will be asked whether they would also be willing to take part in an additional qualitative study. A subgroup of participants will be selected from those that have indicated a willingness to take part in the qualitative study. Also, at the screening visit participants will be asked whether they have a carer. Having a carer is not a pre-requisite for PwPD being recruited into the trial. It is likely that some PwPD in the trial may not have a suitable carer. Where one is available, they will be invited to join the trial: if there is more than one, the main family carer, as identified by the PwPD, will be approached.
详细描述
This is a multi-centre, single-blinded, randomised, controlled trial for PwPD to compare (i) OPTIM-PARK II (a novel personalised treatment based on the latest published research evidence and results from our extensive development work undertaken in OPTIM-PARK I) and routine care with (ii) routine care alone. The research team will provide a personalised list of available resources to the routine care arm at the end of the trial. The trial aims to recruit 60 PwPD and their carers (n=60) in the UK. This trial took place in 4 countries (Denmark, Norway, Spain and UK) but only Spain and UK included control groups, data collection in these two countries started in October 2022, after the iterative phase of the trial.
Participants allocated to the control group will received usual care and participants in the intervention group the Optim Park intervention.
This intervention will consist of the following:
First consultation with PwPD and carer "entrance" at point of entry to the study
The initial consultation with the PwPD and the carer will be a face-to-face consultation in the participants own home or at the clinic/primary care centre/community hub based on participants preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants cannot be blinded to the intervention they are receiving. Outcome assessors and the main investigators are blinded to group allocation and will not have access to the intervention treatment lists. Only the statistician performing the randomization, the team member supporting the coordinator and the coordinator who is delivering the intervention are aware of group allocation.
However, previous experience has shown that participants may occasionally and inadvertently inform assessors of the treatment they are receiving. The research team aim to reduce this effect by explicit reminders to participants before assessment visits. The research team shall ask all assessors to record their estimate of which group they think the participant belongs, and their confidence in that prediction. This will enable to test whether inadvertent loss of blinding leads to bias, and to adjust for any bias detected.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PwPD are eligible to be included in the trial if they meet the following criteria:
- •Have a confirmed Consultant's diagnosis of Parkinson's disease.
- •Live at home.
- •Able to give informed consent.
- •Able to understand and follow commands.
- •Willing to take part in the Optim Park II intervention.
- •Carers of PwPD are eligible to be included in the trial if they meet the following criteria:
- •The PwPD they are caring for has given informed consent.
- •Live at home.
- •Able to give informed consent.
- •Able to understand and follow commands.
- •Willing to take part in the Optim Park II intervention.
排除标准
- •Participants who are currently hospitalised or acutely unwell will not be eligible to being included in the trial.
研究组 & 干预措施
Usual care ( control)
All participants in the trial will continue with their usual care as deemed appropriate by health care providers, this will usually comprise attendance at medical clinics, medication, and visits from PD nurse specialists. Participants may attend group activities or access resources as part of their usual care, though from experience such sessions are rarely intensive or prolonged. Participants will be asked to record their usual care and encouraged to avoid changing that practice unless specifically requested by a health care worker during the time they are participating in the trial.
Optim Park Intervention
A central component of the Optim-Park II intervention is to offer a single point of contact with a coordinator (appointed for the purpose of delivering the Optim-Park II intervention) to assess participants needs, have a discussion with participants to identify 3 main problems/targets PwPD and carers would most like to address based on their needs and then link up and refer participants to available community resources.
The coordinators will deliver the Optim-Park intervention for PwPD and their carers in three consultations: a consultation after the baseline assessment and randomization has been undertaken at the point of "entrance" to the study; a consultation in the middle of this period; and a follow-up consultation at "exit" at 3 months. Each consultation can last between 30 min and up to 2 hours. Each consultation can be with the pair of PwPD and carer or if appropriate, separately.
干预措施: Optim Park Intervention (Other)
结局指标
主要结局
Resources used in the community (assessing change)
时间窗: Completed at baseline and 3 months post randomisation follow-up assessment
Resources identified and used as recorded in the Resource log (by the coordinator) and in the resource log diary (by patients and carers)
次要结局
- Duke University of Carolina Social support Questionnaire (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Parkinson Disease quality of life Carer Scale (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Parkinson Disease Quality of Life 39 questionnaire (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Caregiver Burden Scale (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Health and social care resource use sheet (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Euro Quality of Life 5 Dimension (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)