ISRCTN18337380已完成未知
Evaluation of the clinical and cost effectiveness of Short-term Integrated Palliative Care Services (SIPC) to OPTimise CARE for people with advanced long-term Neurological conditions (OPTCARE Neuro)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 350
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32857151/ results (added 02/09/2020) 2017 Other publications in https://pubmed.ncbi.nlm.nih.gov/28774963/ (added 15/02/2023) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32902934/ (added 15/02/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults (aged 18 years or over) severely affected by advanced or progressive stages of the long-term neurological conditions (LTNCs) of either*:
- •1.1. Multiple Sclerosis (MS) - patients with either aggressive relapsing disease with rapid development of fixed disability or those with advanced primary or secondary progressive disease, often with limitation in a number of areas including gait and upper limb function. We do not define referral based on disability but would expect most patients to have an Expanded Disability Status Scale (EDSS) of at least 7.5
- •1.2. Parkinsonism & related disorders (PRDs) i.e.
- •1.2.1. Idiopathic Parkinson’s Disease (IPD), Hoehn and Yahr (H&Y) stages 4-5 OR
- •1.2.2. Progressive Supranuclear Palsy (PSP) Hoehn and Yahr (H&Y) stages 3-5 OR
- •1.2.3. Multiple System Atrophy (MSA) - Hoehn and Yahr (H&Y) stages 3-5
- •1.3. Motor Neurone Disease (MND) all stages
- •2. Who are deemed (by referring/usual care clinicians) to have:
- •2.1. An unresolved symptom (e.g. pain or another symptom) which has not responded to usual care
- •2.2. AND at least one of the following: unresolved other symptoms (e.g. breathlessness, nausea/vomiting, spasticity, fatigue); cognitive problems; complex psychological (depression, anxiety, loss, family concerns), communication/information problems and/or complex social needs.
- •3. Who are able to give informed consent^ OR where their capacity can be enhanced^ (e.g. with information) so they can give informed consent OR where a personal consultee^ can be identified and approached to give an opinion on whether or not the patient would have wished to participate in the study.
- •4. Are living in the catchment area of the Short-term Integrated Palliative Care Service (SIPC)
- •Patients are expected to be in the advanced or progressive stages of disease. They may be living at home (most common), in a nursing home or in hospital at the time of recruitment. A proforma will be developed for referring clinicians to complete (covering contact and clinical information and important reasons for referral/selection).
- •Caregivers:
- •1. Adults (aged 18 years or over) identified by the patient as the person closest to them, usually a family member, close friend, informal caregiver or neighbour.
- •2. Able to give informed consent to complete the questionnaires
- •* Diagnosis must have been established by a specialist neurological assessment
- •^ When a person lacks capacity to consent for themselves the procedures detailed in the Mental Capacity Act (2005) are adhered to
排除标准
- •Patients who meet the inclusion criteria but:
- •1. Are already receiving specialist palliative care
- •2. Lack capacity and have no family member, friend or informal caregiver who is willing and available to complete questionnaires about their own and the patient’s symptoms and circumstances
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