The Bridges Self-management Programme for People With Neuromuscular Diseases
NCT05460156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2023-11-28
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Bridges Self-management Support
Self-management support intervention tailored for people with neuromuscular diseases
Sponsors & Collaborators
-
University College London Hospitals
lead OTHER
Principal Investigators
-
Gita Ramdharry · UCLH NHS Trust
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-14
- Primary Completion
- 2023-09-01
- Completion
- 2023-11-27
Countries
- United Kingdom
Study Locations
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