LIving BEtteR With asThma - Intervention Development Study

NCT ID: NCT06159803

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-19
• Study Completion Date: 2025-11-01

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient

Adult patients with difficult asthma:

1. To carry out semi-structured interviews with PDA to explore their experiences, beliefs and attitudes to exercise, diet and emotional self-management support.

2. To carry out semi-structured interviews with PDA that explores the barriers and facilitators to key behaviours that will be targeted in the intervention.

3. To carry out iterative think aloud with PDA to elicit feedback on drafts of the intervention to optimise the intervention.

Qualitative Interview

Intervention Type: BEHAVIORAL

One-to-one semi-structured interviews and Think Aloud interviews

NHS professionals/Exercise professionals

NHS professionals working with people living with difficult asthma:

Exercise professionals working with people living with difficult asthma:

1. To carry out semi-structured interviews with health care and exercise professionals who work with patients living with severe asthma to explore their experiences, beliefs and attitudes to providing exercise, diet and emotional self-management support to this patient group

2. To carry out semi-structured interviews with health care and exercise professionals who work with patients living with severe asthma that explores the barriers and facilitators to key components that are planned to be included in the intervention.

3. To carry out iterative think aloud with health care and exercise professionals who work with patients living with severe asthma to elicit feedback on drafts of the intervention to optimise the intervention

Qualitative Interview

Intervention Type: BEHAVIORAL

One-to-one semi-structured interviews and Think Aloud interviews

Interventions

Qualitative Interview

One-to-one semi-structured interviews and Think Aloud interviews

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Aged 18 or over

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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Judit Varkonyi-Sepp

Southampton, Hampshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Anna Freeman

Role: CONTACT

a.freeman@soton.ac.uk

02381206397

Judit Varkonyi-Sepp

Role: CONTACT

J.Varkonyi-Sepp@soton.ac.uk

02381206315

Facility Contacts

Judit Varkonyi-Sepp, Chief Investigator

Role: primary

j.varkonyi-sepp@soton.ac.uk

+44 023 8120 6315

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Related Links

https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf.

Asthma GIf. Global Strategy for Asthma Management and Prevention 2021

http://www.ncbi.nlm.nih.gov/pubmed/11752478

Braun V, Clarke V. Using thematic analysis in psychology Using thematic analysis in psychology. Qual Res Psychol \[Internet\]. 206AD;3:77-101

http://www.hra.nhs.uk/resources/after-you-apply/amendments/

HRA guidance

https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

ICMJE - Roles and Responsibilities of Authors, Contributors, Reviewers, Editors, Publishers, and Owners

Other Identifiers

RHM MED2028

Identifier Type: -

Identifier Source: org_study_id