LIving BEtteR With asThma - Intervention Development Study (LIBERTY-ID)

April 16, 2024 updated by: University Hospital Southampton NHS Foundation Trust
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO166YD
        • Recruiting
        • Judit Varkonyi-Sepp
        • Contact:
        • Principal Investigator:
          • Anna Freeman, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: Qualitative Interview
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
Behavioral: Qualitative Interview
One-to-one semi-structured interviews and Think Aloud interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative interviews
Time Frame: 24 months
Experiences, preferences and perceived barriers to support for exercise, diet and emotional self-management of people living with asthma and professionals working with people living with asthma
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 19, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHM MED2028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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