LIving BEtteR With asThma - Intervention Development Study

NCT06159803 | Recruiting

• 1 other identifier: RHM MED2028
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Qualitative interviews

  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

Study Arms (2)

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

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

Interventions

Qualitative Interview BEHAVIORAL

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

NHS professionals/Exercise professionals; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

Judit Varkonyi-Sepp

Southampton, Hampshire, SO166YD, United Kingdom

RECRUITING

Related Publications (16)

• Freeman A, Cellura D, Minnion M, Fernandez BO, Spalluto CM, Levett D, Bates A, Wallis T, Watson A, Jack S, Staples KJ, Grocott MPW, Feelisch M, Wilkinson TMA. Exercise Training Induces a Shift in Extracellular Redox Status with Alterations in the Pulmonary and Systemic Redox Landscape in Asthma. Antioxidants (Basel). 2021 Nov 30;10(12):1926. doi: 10.3390/antiox10121926.

  PMID: 34943027 BACKGROUND

• Grimmett C, Bates A, West M, Leggett S, Varkonyi-Sepp J, Campbell A, Davis J, Wootton S, Shaw C, Barlow R, Ashcroft J, Scott A, Moyes H, Hawkins L, Levett DZH, Williams F, Grocott MPW, Jack S. SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open. 2021 Aug 26;11(8):e048175. doi: 10.1136/bmjopen-2020-048175.

  PMID: 34446487 BACKGROUND

• Yardley L, Morrison L, Bradbury K, Muller I. The person-based approach to intervention development: application to digital health-related behavior change interventions. J Med Internet Res. 2015 Jan 30;17(1):e30. doi: 10.2196/jmir.4055.

  PMID: 25639757 BACKGROUND

• GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.

  PMID: 33069326 BACKGROUND

• Tay TR, Hew M. Comorbid "treatable traits" in difficult asthma: Current evidence and clinical evaluation. Allergy. 2018 Jul;73(7):1369-1382. doi: 10.1111/all.13370. Epub 2017 Dec 15.

  PMID: 29178130 BACKGROUND

• McDonald VM, Hiles SA, Godbout K, Harvey ES, Marks GB, Hew M, Peters M, Bardin PG, Reynolds PN, Upham JW, Baraket M, Bhikoo Z, Bowden J, Brockway B, Chung LP, Cochrane B, Foxley G, Garrett J, Jayaram L, Jenkins C, Katelaris C, Katsoulotos G, Koh MS, Kritikos V, Lambert M, Langton D, Lara Rivero A, Middleton PG, Nanguzgambo A, Radhakrishna N, Reddel H, Rimmer J, Southcott AM, Sutherland M, Thien F, Wark PAB, Yang IA, Yap E, Gibson PG. Treatable traits can be identified in a severe asthma registry and predict future exacerbations. Respirology. 2019 Jan;24(1):37-47. doi: 10.1111/resp.13389. Epub 2018 Sep 19.

  PMID: 30230137 BACKGROUND

• Hansen ESH, Pitzner-Fabricius A, Toennesen LL, Rasmusen HK, Hostrup M, Hellsten Y, Backer V, Henriksen M. Effect of aerobic exercise training on asthma in adults: a systematic review and meta-analysis. Eur Respir J. 2020 Jul 30;56(1):2000146. doi: 10.1183/13993003.00146-2020. Print 2020 Jul.

  PMID: 32350100 BACKGROUND

• Freitas PD, Ferreira PG, Silva AG, Stelmach R, Carvalho-Pinto RM, Fernandes FL, Mancini MC, Sato MN, Martins MA, Carvalho CR. The Role of Exercise in a Weight-Loss Program on Clinical Control in Obese Adults with Asthma. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Jan 1;195(1):32-42. doi: 10.1164/rccm.201603-0446OC.

  PMID: 27744739 BACKGROUND

• Paolucci EM, Loukov D, Bowdish DME, Heisz JJ. Exercise reduces depression and inflammation but intensity matters. Biol Psychol. 2018 Mar;133:79-84. doi: 10.1016/j.biopsycho.2018.01.015. Epub 2018 Feb 3.

  PMID: 29408464 BACKGROUND

• Cordova-Rivera L, Gibson PG, Gardiner PA, McDonald VM. A Systematic Review of Associations of Physical Activity and Sedentary Time with Asthma Outcomes. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):1968-1981.e2. doi: 10.1016/j.jaip.2018.02.027. Epub 2018 Mar 3.

  PMID: 29510231 BACKGROUND

• Garcia-Aymerich J, Varraso R, Anto JM, Camargo CA Jr. Prospective study of physical activity and risk of asthma exacerbations in older women. Am J Respir Crit Care Med. 2009 Jun 1;179(11):999-1003. doi: 10.1164/rccm.200812-1929OC. Epub 2009 Feb 26.

  PMID: 19246716 BACKGROUND

• Freeman AT, Hill D, Newell C, Moyses H, Azim A, Knight D, Presland L, Harvey M, Haitchi HM, Watson A, Staples KJ, Kurukulaaratchy RJ, Wilkinson TMA. Patient perceived barriers to exercise and their clinical associations in difficult asthma. Asthma Res Pract. 2020 Jun 9;6:5. doi: 10.1186/s40733-020-00058-6. eCollection 2020.

  PMID: 32537235 BACKGROUND

• Azim A, Freeman A, Lavenu A, Mistry H, Haitchi HM, Newell C, Cheng Y, Thirlwall Y, Harvey M, Barber C, Pontoppidan K, Dennison P, Arshad SH, Djukanovic R, Howarth P, Kurukulaaratchy RJ. New Perspectives on Difficult Asthma; Sex and Age of Asthma-Onset Based Phenotypes. J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3396-3406.e4. doi: 10.1016/j.jaip.2020.05.053. Epub 2020 Jun 13.

  PMID: 32544545 BACKGROUND

• Varkonyi-Sepp J, Freeman A, Ainsworth B, Kadalayil LP, Haitchi HM, Kurukulaaratchy RJ. Multimorbidity in Difficult Asthma: The Need for Personalised and Non-Pharmacological Approaches to Address a Difficult Breathing Syndrome. J Pers Med. 2022 Aug 31;12(9):1435. doi: 10.3390/jpm12091435.

  PMID: 36143220 BACKGROUND

• Morrison L, Muller I, Yardley L, Bradbury K. The person-based approach to planning, optimising, evaluating and implementing behavioural health interventions. The European Health Psychologist. 2018;20(3):464-9

  BACKGROUND

• Bourgeault, I., Dingwall, R., & De Vries, R. (Eds.). (2010). The SAGE handbook of qualitative methods in health research. Sage Publications Ltd., London

  BACKGROUND

Related Links

• Asthma GIf. Global Strategy for Asthma Management and Prevention 2021
• Braun V, Clarke V. Using thematic analysis in psychology Using thematic analysis in psychology. Qual Res Psychol \[Internet\]. 206AD;3:77-101
• HRA guidance
• ICMJE - Roles and Responsibilities of Authors, Contributors, Reviewers, Editors, Publishers, and Owners

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Anna Freeman

CONTACT

02381206397; a.freeman@soton.ac.uk

Judit Varkonyi-Sepp

CONTACT

02381206315; J.Varkonyi-Sepp@soton.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: December 7, 2023
• Study Start: April 19, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)