The Bridges Self-management Programme for People With Neuromuscular Diseases

NCT05460156 | Completed

• 1 other identifier: 137025
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• Semi-structured interview: Feasibility and acceptability of the intervention

  Recruitment and participant experience

  Up to 3 months

Secondary Outcomes (5)

• Euroquol-5D

  Up to 3 months

• 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

Study Arms (1)

NM Bridges

EXPERIMENTAL

Receive NM Bridges supportive care from trained personnel

Behavioral: Bridges Self-management Support

Interventions

Bridges Self-management Support BEHAVIORAL

Self-management support intervention tailored for people with neuromuscular diseases

NM Bridges

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

Queen Square centre for Neuromuscular Diseases

London, Greater London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Gita Ramdharry

  UCLH NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: July 15, 2022
• Study Start: February 14, 2022
• Primary Completion: September 1, 2023
• Study Completion: November 27, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)