Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05460156 |
| Other study ID # |
137025 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 14, 2022 |
| Est. completion date |
November 27, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University College London Hospitals |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Objectives
1. To explore the feasibility of delivering and evaluating NM Bridges through a single,
specialist service:
1. 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
2. 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)
2. 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)
- Monitor fidelity to the intervention itself (intervention fidelity) e.g. adherence
to the intended program content, and responsiveness, quality and competence in
delivering the program.
- Explore acceptability of the implementation strategy package to clinicians at the
specialist centre (Explored through semi-structured qualitative interviews).
- Identify barriers and facilitators to the implementation strategy package
- Explore appropriateness and practicability of the implementation strategy package
to the specialist clinical service (Explored through semi-structured qualitative
interviews).
- Monitor effect of implementation strategy package on adoption of the intervention
- Assess the level of system change required needed to integrate the intervention
into the existing infrastructure, to help determine whether intervention delivery
in this setting is truly feasible. (Explored through semi-structured qualitative
interviews).
3 Trial design This hybrid study will involve testing the feasibility of a clinical
intervention (NM Bridges) and a simultaneous testing of the feasibility of an
implementation strategy package (informed by NPT), with a view to increasing speed
of translation (41). Below, the rationale for our design choices are summarised.
Mixed methods An embedded experimental mixed methods design will be used to address the
research questions, and is an often used design when evaluating health services research. An
embedded design, where one data set provides a supportive secondary role to the other, is
frequently used when researchers need to include a qualitative component within a
quantitative study. A sequential two-phase approach will be employed, where the use of
qualitative methods post intervention will enable the team to follow up on the participants'
experiences of the intervention, and the experiences of staff delivering the intervention.
Outcome measures (Quantitative methods) Outcome measures will be completed at baseline,
directly after receiving the intervention and 3 months afterwards. There will be the option
for outcome measures to be completed remotely, for participant convenience, and to reduce
risk associated with the current COVID-19 pandemic.
Semi-structured interviews (Qualitative methods) Ten participants will be recruited for
semi-structured interviews to explore their experiences of receiving NM Bridges. Interviews
will be audio recorded and transcribed by an external service, who are approved by UCL for
such work (Fingertips Typing Services). Thematic analysis and validation will be undertaken
by the PhD student.
Six Queen Square Centre For Neuromuscular Diseases (CNMD) staff will be interviewed at the
end of the intervention phase of the study to investigate determinants of implementation
behaviour and explore experiences of delivering NM Bridges as part of the clinical service.
Themes will include benefits, challenges, suggestions for streamlining delivery, translation
to other areas and environments. Interviews will be audio recorded and transcribed by an
external service, who are approved by UCL for such work (Fingertips Typing Services).
Thematic analysis and validation will be undertaken by the PhD student.
Setting The Queen Square Centre for Neuromuscular Diseases (CNMD) is a specialist research
and clinical centre which specifically focuses on genetic and acquired neuromuscular
diseases. It provides comprehensive NHS clinical services for over 5,000 patients per year
which include a range of specialist neuromuscular clinics and nationally commissioned
services.
Participant selection Considering the rare nature of many NMDs, recruitment of a
heterogeneous sample for this work could be considered as pragmatic, and may augment the
ecological validity of the trial, as this is what the day-to-day clinics in a specialist NMD
centre are realistically likely to look like.
Staff Training The training for 6 members of the CNMD clinical team has been costed into this
grant, and as such, 6 health professionals from the centre will receive Bridges
Self-Management training. An education training package specific to the clinical and
organisational context has been co-produced with key stakeholders (patients, occupational
therapists, physiotherapists and specialist nurses at the CNMD), in order to ensure the
training is reflective, sensitive and tailored to the unique environment in which it will be
delivered.
Delivery The intervention will be delivered in a one-off session as part of routine therapy
and nursing appointments. The intervention is designed to be woven into routine clinical
appointments, it is therefore not expected that delivering NM Bridges will have any adverse
effect on the time it takes to deliver appointments, the care that participants receive, or
the workload of clinicians.
Patient recruitment at a site will only commence once evidence of the following
approval/essential documents are in place:
Participant recruitment at a site will only commence when the trial has:
1. Been confirmed by the Sponsor (or it's delegated representative), and
2. Been issued an 'NHS permission letter'.
3. Has regulatory body approval from REC and HRA.
Patients with NMD attending the CNMD clinics will be invited to participate by the PI or
other members of the clinical care team. The PI is part of the clinical care team. Suitable
patients will be approached by the clinical care team or research team during routine
clinics. The initial approach will only be done by a member of the clinical team. The purpose
of the study will be explained, the terms of participation and any queries answered. A PIS
(reviewed by a PPI group set up specifically for the study) will be handed out to all those
interested in the study. The research team will follow up interested patients wishing to
consider their participation. Permission will be sought to contact interested patients,
contact details will be taken and they will be sent a study information sheet to review in
their own time. Participants may also be recruited from physiotherapy clinics at the National
Hospital for Neurology and Neurosurgery.
The clinical care team will identify potential participants who will be sent a letter of
invitation to participate, a study information sheet and details of how to register interest
in the study by telephone, email or letter. On receipt of an expression of interest, contact
will be made with the patient by a member of the research team.
Interested patients will be given at least one week to consider the study before they are
asked to decide whether to take part.
4 Informed consent A copy of the signed Informed Consent form will be given to the
participant. The original signed form will be retained in the trial file at site and a copy
placed in the medical notes. This will also be the case for remote consent.
Product/Interventions
1. Name and description of intervention under investigation
Neuromuscular Bridges Self-Management Support Programme (NM Bridges) NM Bridges is a
co-produced intervention delivered to individual service users by healthcare
professionals, and supported by a patient held workbook. NM Bridges is an adaptation
adapted of the original programme for individuals with stroke. It is based on the
principle of self-efficacy, defined as ''the belief in one's capabilities to organize
and execute the courses of action required to produce given attainments''. More
information on the history and development of Bridges is found in the background section
under NM Bridges
Overview of the Bridges self-management package:
Training for practitioners including:
• Theory, research and practical examples relating to stroke and self-management
- Debate and discussion about integration into practice, using case-based examples
- Practice using Bridges principles and patient workbook
- Completion of case reflections from using NM Bridges in practice
- Developing individual and team action plans
Supporting self-management skills using:
Daily interactions • Encouraging problem-solving
• Enabling use of personal resources
• Changing focus of therapy
Patient-held workbook • Peer example 'vignettes'
• Reflecting on progress
• Recording aspirations/hopes
- Small targets
Adaptions to the Bridges intervention to contextualise to the clinical setting
(specialist service) and population (NMDs)
- Option for remote delivery to mitigate impact of COVID-19
- Co-production of Bridges resources (workbook/digital tool
- Health delivery system: intervention optimised for one-off clinical interactions as
opposed to multiple rehabilitation sessions
- Co-design of new educational package for clinicians: Pre-trial consultation with
staff at the centre revealed that patients will often only have one or two sessions
per year, meaning that the intervention needs to be able to be delivered as part of
a one-off session to fit into the structure of the clinical service at Queen
Square. Subsequently, the NM Bridges educational package for clinicians (their
training in how to deliver the intervention) has been co-designed with key
stakeholders so that it can be delivered in a one-off session (rather than in
multiple sessions as it has been in previous trials).
