Process evaluation of the MucAct COPD RCT v1
Research type
Research Study
Full title
Process evaluation of the MucAct COPD Randomised Controlled Trial exploring the clinical effectiveness and cost-effectiveness of nebulised 7% sodium chloride in patients with chronic obstructive pulmonary disease.
IRAS ID
301938
Contact name
Fiona M Harris
Contact email
Sponsor organisation
University of Stirling
Clinicaltrials.gov Identifier
281629, IRAS approval for the MucAct COPD RCT
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Most clinical trials include a process evaluation (PE). This aims to learn what works best and what might be improved in both how the trial is delivered by staff and experienced by patients. We are conducting a PE within a trial of a new treatment for people with COPD. The aim of the new treatment is to help people clear up phlegm and reduce the number of chest infections.
Aims:
The PE aims to explore how participants are recruited into the trial, how it is delivered and what participants' views are of taking part in the trial. This is so that we can learn about what might help or hinder achieving the intended improvements in treatment for patients.How we will do the study:
We will observe how the trial is delivered in five clinical sites and interview key staff to find out what is working well and what might be improved. We will also speak to trial participants to find out what they think of the treatment and taking part in the trial. If possible, we will also talk to people who decided not to join the trial but agreed to talk to us about their reasons. This is important so that we can help the trial team to address any issues that might improve the trial procedures and also understand whether these processes and treatments are being adhered to as intended.The trial has been approved by an NHS REC and we are seeking separate approval for the PE. The PE benefits from input from social scientists, clinicians, a patient co-applicant and a patient advisory group.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0237
Date of REC Opinion
5 Nov 2021
REC opinion
Further Information Favourable Opinion