ISRCTN38920246已完成未知
A longer-term care strategy to support stroke survivors and their carers (LoTS2Care) – a feasibility study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 269
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29891011 protocol 2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29996895 protocol for the process evaluation 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33819000/ (added 21/04/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36922866/ feasibility and acceptability outcomes (added 17/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/07/2017:
- •Stroke Service Inclusion Criteria:
- •1. Encompasses primary and secondary care over a defined geographical area within the United Kingdom (UK)
- •2. Includes a stroke unit which fulfils the RCP guidelines definition of a stroke unit
- •3. Agree to try and establish a robust mechanism to identify all stroke survivors at four to six months post stroke.
- •4. Have the facilities and capacity to deliver the New Start intervention
- •5. Fully supportive of time required for New Start training, including two face to face away days and online training
- •6. Agreement to be involved via signed model Non-Commercial Agreement (mNCA) and local management approval
- •Stroke survivor inclusion criteria:
- •1. At least four months and not more than six months since confirmed primary diagnosis of new stroke
- •2. Are residing in the community (i.e. not in a nursing or residential care home
- •3. Provide informed consent or consultee assent
- •Carer inclusion criteria (participation optional):
- •1. Identified by the stroke survivor, as the main informal caregiver who provides the stroke survivor with support a minimum of once per week
- •2. Provided informed consent (i.e. implied via return of completed baseline questionnaire)
- •Previous inclusion criteria:
- •Stroke Service Inclusion Criteria:
- •1. Encompasses primary and secondary care over a defined geographical area within the United Kingdom (UK)
- •2. Includes a stroke unit which fulfils the RCP guidelines definition of a stroke unit
- •3. Agree to try and establish a robust mechanism to identify all stroke survivors at four to seven months post stroke.
- •4. Have the facilities and capacity to deliver the Moving Forward intervention
- •5. Fully supportive of time required for Moving Forward training, including two face to face away days and online training
- •6. Agreement to be involved via signed model Non-Commercial Agreement (mNCA) and local management approval
- •Stroke survivor inclusion criteria:
- •1. At least four months and not more than seven months since confirmed primary diagnosis of new stroke
- •2. Are residing in the community (i.e. not in a nursing or residential care home
- •3. Provide written informed consent or consultee assent
- •Carer inclusion criteria (participation optional):
- •1. Identified by the stroke survivor, as the main informal caregiver who provides the stroke survivor with support a minimum of once per week
- •2. Provided informed consent (i.e. implied via return of completed baseline questionnaire)
排除标准
- •Current inclusion criteria:
- •Stroke services exclusion criteria:
- •1. Previously participated in the development of the intervention; as part of this programme of research or are intending to implement the New Start intervention within the proposed duration of the study will not be eligible because these sites might be expected to have enhanced skills or knowledge about the New Start intervention
- •2. Stroke services that are currently delivering or planning to deliver a similar supported self-management intervention
- •Stroke survivors exclusion criteria:
- •It is unknown whether the Moving Forward intervention can be delivered to Stroke Survivors with other (specific) co-morbidities. Therefore, no exclusion criteria will be applied and reasons for not receiving care at 6 months post-stroke will be documented and used to inform eligibility criteria for a definitive trial.
- •Carer exclusion criteria:
- •Their stroke survivor does not consent for carer involvement.
- •Previous exclusion criteria:
- •Stroke services exclusion criteria:
- •1. Previously participated in the development of the intervention; as part of this programme of research or are intending to implement the Moving Forward intervention within the proposed duration of the study will not be eligible because these sites might be expected to have enhanced skills or knowledge about the Moving Forward intervention
- •2. Stroke services that are currently delivering or planning to deliver a similar supported self-management intervention
- •Stroke survivors exclusion criteria:
- •1. Main requirement is palliative care
- •2. Have concurrent major illness which is likely to predominately determine care (e.g. in receipt of consistent medical input from a specialist other than stroke/neurologist)
- •3. Stroke survivors not resident within the geographical area covered by the stroke service
- •Carer exclusion criteria:
- •Their stroke survivor does not consent for carer involvement.
研究者
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