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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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