SCooP2: Supporting Children’s Physiotherapy for cystic fibrosis – a pilot trial of an audio-visual intervention

Cystic fibrosis (CF) is an inherited, life-threatening disorder of the lungs and digestive system that affects approximately 1 in 2,500 children in the UK. The median age of survival is 56 years old. Chest physiotherapy is a principal component of cystic fibrosis respiratory management, applied from birth to clear mucus from the lungs, with an aim of preventing pulmonary infection and consequent lung damage.

On average parents and young children with CF complete only 50% of their clinically-prescribed physiotherapy schedule. Early intervention in childhood to improve adherence to chest physiotherapy for cystic fibrosis is crucial to avoid irreversible lung damage. Interventions to improve and sustain treatment adherence are one of the top ten patient research priorities. Despite the importance of chest physiotherapy and the current high non-adherence rates in young children there is a lack of interventions to address this significant problem and a lack of evidence about intervention effectiveness.

Our prior research developed a theoretically-based, empirically-informed, audio-visual intervention to support and motivate parents to adhere to physiotherapy and accompanying action plan resource to facilitate translation of intentions into behaviour change. This PhD research will conduct a pilot randomised trial of a novel theoretically-based, empirically-informed audio-visual intervention to increase physiotherapy adherence in young children aged 0-8 years with CF. The PhD will inform future conduct of a randomised trial of the effectiveness and cost-effectiveness of the intervention for increasing physiotherapy adherence versus ‘usual care’ control.

Suggested aims:  

• To assess in a Phase II pilot trial if it is possible to (a) recruit, (b) randomise, and (c) retain sufficient participants across sites.  
• To compare the effectiveness of different recruitment approaches.  
• To confirm estimates of the sample size required for a Phase III randomised trial.  
• To identify and investigate if and how mediating factors impact upon trial processes including intervention fidelity.
• To determine if a future Phase III trial can be conducted based on explicit progression criteria.