Clinical trial NCT06159803: LIving BEtteR With asThma - Intervention Development Study
Official title: LIving BEtteR With asThma - Intervention Development Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research population of interest for this study is people living with difficult asthma and health care and exercise professionals working with people with difficult asthma.

Brief summary: Approximately 330 million people in the world are living with asthma and 3-10% of them has difficult asthma that is challenging to control even with maximum doses of pharmacological treatment. In the last five years our multidisciplinary team has shown the clinical benefits of a short-term structured exercise programme for people living with difficult asthma (PDA) (1). However, engaging PDA in self-maintained exercise long-term and outside of the hospital environment remains a challenge. Changing and maintaining behaviours requires complex psychological and cognitive processes and appropriate modes of support by skilled practitioners. Underpinned by behavioural science and health psychology principles, our team has developed a world renown multimodal self-management support intervention for people living with cancer (2). The intervention focuses on initiating and maintaining exercise, optimising diet and includes supporting people through the cognitive and psychological processes to change their behaviour. We aim to adapt this intervention for PDA to optimise their self-management via the LIBERTY study. To achieve the best outcomes, prior to commencing the LIBERTY study, we aim to develop the intervention using the acclaimed Person-Based Approach (PBA) (3). This methodology is considered gold standard in behaviour change intervention development, implementation and evaluation and maximise the probability of the uptake and maintenance of the desired behaviour.

Detailed description: The burden of poor asthma control remains high in the United Kingdom (UK). Given high asthma prevalence, poor asthma control exerts significant impact at individual and societal levels and accounts for one fifth of the total chronic respiratory disability-adjusted life year burden (4). 'Remission' or well-controlled asthma requires continuation of regular medical treatment, sustained adherence to medications and other self-management behaviours (e.g. healthy diet, avoiding triggers, physical activity), and exposure to risk of potential medication side effects with plus ongoing financial implications. 3-10% of people living with asthma has difficult asthma, defined as asthma that is uncontrolled despite GINA (Global Initiative for Asthma) Step 4 or 5 treatment (5) or requires such treatment to maintain good control and reduce exacerbations. It is increasingly recognised that problematic difficult asthma is a multidimensional state comprising numerous treatable traits that merit targeted approaches (6). This multimorbid disease framework (defined as the coexistence of \>2 health conditions) is particularly prevalent in difficult asthma and represents a complex constellation of conditions that collectively impose a significant burden on the patient (7) These treatable traits can be pulmonary, extrapulmonary and behavioural (7). Treatable traits, including obesity, anxiety and depression, dysfunctional breathing and inactivity predict future exacerbation risk in difficult asthma, and so addressing these should be a key part of asthma management for both individual patient benefit and health economic reasons (8). Multimodal non-pharmacological approaches are needed to do that but there is limited understanding of their role in difficult asthma to guide their use.

Eligibility criteria: Inclusion Criteria Patient arm:

* Age 18 or over
* Must have had a diagnosis of difficult asthma
* Giving informed consent

Inclusion Criteria Professionals arm:

Aged 18 or over

* Healthcare professional or exercise professional with experience of working with people living
* with difficult asthma
* Giving informed consent

Exclusion Criteria Patient arm:

* Less than 18 years old
* Does not have a diagnosis of difficult asthma
* Unwilling or unable to give informed consent
* Unwilling or unable to participate in the interview
* Participation in the LIBERTY pilot study

Exclusion Criteria Professionals arm:

* Less than 18 years old
* Not a healthcare professional or exercise professional
* Not having experience of working with people living with difficult asthma
* Unwilling or unable to give informed consent
* Unwilling or unable to participate in the interview

Primary outcomes:
measure: Qualitative interviews
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Judit Varkonyi-Sepp
state: Hampshire
Study officials:
References:
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