The Bridges Self-management Programme for People With Neuromuscular Diseases: A Hybrid II Effectiveness-implementation Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Semi-structured interview: Feasibility and acceptability of the intervention
研究概览
简要总结
Objectives:
- To evaluate the feasibility of delivering the Neuromuscular Bridges Self-Management Programme (NM Bridges) in addition to usual care.
- To evaluate the feasibility of an implementation strategy package and identify barriers and facilitators to implementation of NM Bridges at a specialist neuromuscular centre.
Type of trial: A hybrid II feasibility trial Trial design and methods:A hybrid trial which simultaneously investigates both the feasibility of NM Bridges, and the feasibility of a package of implementation strategies.
Trial duration per participant: 4 months Estimated total trial duration: 1 year Planned trial sites: Single site Total number of participants planned: 60 Main inclusion/exclusion criteria: Participants will be over the age of 18, with a diagnosis of neuromuscular disease from a neurologist at the Queen Square Centre for Neuromuscular Diseases (CNMD). Participants will be deemed by healthcare professionals to have the capacity to give informed consent to participate in the research.
Statistical methodology and analysis:
This is a single-arm cohort study of feasibility of the NM Bridges intervention. The primary analysis will be of feasibility of conducting a trial of the intervention within a single pilot site. Secondary analysis will be calculation of effect sizes of patient reported outcome measures (PROMS). The investigators will also be interviewing participants and qualitative analysis methods will be used.
详细描述
Objectives
-
To explore the feasibility of delivering and evaluating NM Bridges through a single, specialist service:
-
Feasibility of evaluation
- To examine the acceptability and performance of candidate outcome measures that consider the priorities, needs, skills and goals of individuals living with NMD to gain data for a future, larger trial. As this is feasibility work, this trial is not powered for efficacy.
- Explore participant recruitment and retention. (Measured through administrative data and assessment of completeness and quality of the collected data
- feasibility of delivery of the NM Bridges intervention
- Explore acceptability of NM Bridges (to clinicians and participants) when delivered in one-off interactions, as this will be necessary in this new clinical setting, has not been explored in previous trials, and will be required for roll-out to other services. (Explored through semi-structured qualitative interviews).
- Explore demand for NM Bridges within the service. Explored through semi-structured qualitative interviews)
- To evaluate the feasibility of an implementation strategy 'package' to implement NM Bridges at a specialist neuromuscular centre • Monitor fidelity of the implementation process (e.g., training, supervision, and informatics)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •be over the age of 18
- •be a patient at Queen Square Centre for Neuromuscular Diseases or UCLH
- •have a diagnosis of Neuromuscular Disease from a neurologist at the Queen Square Centre for Neuromuscular Diseases.
- •be those whom their healthcare professionals judge have the capacity to give informed consent to participate in the research.
排除标准
- •Patients <18
- •Patients that do not attend clinics at Queen Square Centre for Neuromuscular Diseases or UCLH
- •Patients that do not have the capacity to provide informed consent
- •Patients will be excluded if they have competing comorbidities influencing their rehabilitation, e.g. malignant cancer;
- •have significant issues with their readiness to participate as judged by the clinical team, e.g. illness of a carer; did not require multidisciplinary rehabilitation; or had hearing and visual impairments precluding their ability to fully participate in NM Bridges
结局指标
主要结局
Semi-structured interview: Feasibility and acceptability of the intervention
时间窗: Up to 3 months
Recruitment and participant experience
次要结局
- Self-Efficacy Scale(Up to 3 months)
- Nottingham Extended Activities of Daily Living(Up to 3 months)
- General Health Questionnaire(Up to 3 months)
- Oxford Participation and Activities Questionnaire, Ox-PAQ(Up to 3 months)
- Euroquol-5D(Up to 3 months)
研究者
Gita Ramdharry
Principle Investigator
University College London Hospitals