Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): protocol for a process evaluation of a clinical trial.

ABSTRACT:

Background

We are undertaking a multicentre randomised controlled trial to determine the effectiveness of including a sleep study (polysomnography (PSG)) to assist the commencement of non-invasive ventilation (NIV) in people with motor neurone disease (MND): the Polysomnographic titration of non-invasive ventilation in motor neurone disease (PSG4NIVinMND; 3-three letter acronym; 3TLA) trial. A process evaluation will be conducted alongside the clinical trial to understand: (1) the implementation of the 3TLA intervention in the trial sites, including barriers and enablers, and (2) the mechanisms through which the 3TLA intervention produces change. This protocol paper describes the rationale, aims and methods of the 3TLA process evaluation.

Methods

To guide the design of the p

SUBMITTER: Graco M 

PROVIDER: S-EPMC11884123 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature