Adapting Body Reprogramming for Severe Asthma: a Feasibility Study

Severe Asthma Clinical Trial

— BoBSA  

Official title:

Body Reprogramming as an Adjunct to Biologic Administration in Patients With Severe Asthma: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980755
• Other study ID #: 2109166
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2021
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: Joseph Lanario, MSc
• Phone: 01752 764403
• Email: joseph.lanario[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are many symptoms associated with severe asthma, not all of them related to the lung. These are referred to as extra-pulmonary symptoms and their relationship with quality of life is complex. Body reprogramming (BR) is a non-drug intervention originally developed for fibromyalgia patients with the aim of improving health and wellbeing in a personalised way, with evidence-based lifestyle changes. The frequency and severity of multiple symptoms in severe asthma is similar to fibromyalgia and the investigators propose that BR may be a suitable non-drug intervention for severe asthma patients who are about to step up drug treatment. Our study aims are therefore to assess how BR may be suitable for people with severe asthma, and to adapt and optimise the programme for these people. In two phases, severe asthma patients will be recruited via a regional severe asthma clinic at the Royal Devon & Exeter NHS Trust and invited to take part in a short course of BR. In phase one, patients will be asked to attend four weekly researcher-led sessions of BR via video call and be given practice tasks to report on at the subsequent session. Questionnaires will be completed for the first and last session. At the end of BR, patients will also be invited to take part in a focus group. The data collected will inform development of the programme for phase two, which will involve recruitment of severe asthma patient who are about to start biologic drug treatment for their severe asthma

Description:

There are many symptoms associated with severe asthma, not all of them asthma specific (e.g. mental fog, fatigue, unexplained pain), and the relationship between these symptoms and quality of life is complex. Body reprogramming (BR) is another non-drug intervention originally developed for fibromyalgia patients. BR aims to to improve health and wellbeing in a personalised way, with evidence-based lifestyle changes. The frequency and severity of the non-asthma specific symptoms in severe asthma are similar to those experienced by patients with fibromyalgia. Therefore, the investigators propose that BR may be a suitable non-drug intervention for severe asthma patients who report many non-asthma specific symptoms. This intervention includes optimising knowledge of disease management, physical activity, relaxation and other psychological and biological lifestyle changes which aim to improve wellbeing and mood, and this could lead to better self-management of complex symptoms in asthma patients. Phase 1 Eligible patients attending a severe asthma service at an RD&E Hospital will be identified by a health professional familiar to them and invited to take part in the study by post, including a Participant Invitation, Information Leaflet and consent form. The Invitation Letter and Patient Information Leaflet will include instructions to read the material carefully and to bring the consent form with them to their next scheduled clinic appointment. Participants will be asked to attend four weekly sessions of Body Reprogramming via group video call using Zoom. Each session will include up to 8 patients and will consist of a 25-30 minute live presentation delivered by a researcher from the University of Plymouth. At the end of the presentation, there will be an opportunity to ask questions or raise points of interest. Each session will include a 'practice and report back next week' instruction, and participants will be encouraged to provide written after completing all sessions. feedback before Session topics will include: conceptualising severe asthma, stress and happiness, movement and exercise, and eating and asthma triggers. Demographics (e.g. age) and clinical data (e.g. current drug treatment) will be collected from participants' hospital notes at the start of the programme. Participants will be asked to complete a series of questionnaires for the first and last weeks of Body Reprogramming. These will be posted to participants and returned to the research team using an enclosed FREEPOST envelope. Questionnaires will include: the Severe Asthma Questionnaire (SAQ), the General Symptom Questionnaire (GSQ), the Positive And Negative Affect Schedule (PANAS), the Asthma Control Questionnaire. At the end of the course participants will be asked to complete the much shorter General Symptom Questionnaire-Asthma (GSQ-A) instead of the full GSQ. In addition to these questionnaires participants will also be asked to complete and return the Global Rating of Change Questionnaire (GRCQ) and the Friends and Family Test after completing the intervention. These should take no longer than 20 minutes to complete. Following the course, participants will be invited to attend a focus group with up to 5 other participants via video call or a one to one interview also via video. This time will be used to discuss participants experience of Body Reprogramming, including any problems they may have faced. This will last for up to 2 hours and will be recorded using a voice recorder for transcription and analysis by the research team. Analysis will include generation of summary statistics and mean differences for numerical data, including the number of people who were invited and attended each BR course. Thematic analysis of transcribed focus group data will be used to inform any changes which need to made to improve the programme before Phase 2. Phase 2 Before commencing a biologic treatment for severe asthma in normal clinic care, patients are reviewed by a multidisciplinary team responsible for their care, and the participating hospital's Principal Investigator will identify eligible participants. Participant recruitment will then proceed as outlined in Phase 1. A modified GRCQ will completed by participants at the end of the intervention in phase 2. The changes to the wording of GRCQ are to take into account that participants have started a new treatment (the biologic drug) and completed BR. Except for this change, the same questionnaire data will be collected at the same time-points in this phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Phase one:
• Aged =18 years attending the regional specialist severe asthma service in Royal Devon and Exeter hospitals.
• Diagnosed with severe asthma as per ERS/ATS definition.
• Requiring high dose inhaled corticosteroids (NICE definition of high dose ICS).
• Eight or more non-respiratory symptoms per week (approximately 60% of patients with severe asthma have a moderate or high extra-pulmonary symptom burden) as measured by the General Symptom Questionnaire
• Phase two:
• Diagnosed with severe asthma as per ERS/ATS definition.
• Requiring high dose inhaled corticosteroids (NICE definition of high dose ICS).
• Patients with severe asthma who have been approved for biologic treatment according to national guidance and have been assessed by a multi-disciplinary team will be offered the intervention pending starting their biologic treatment.
• Patients with eight or more non-respiratory symptoms per week as measured by the GSQ.

Exclusion Criteria:

• Phase one and Phase two
• Unable or unwilling to partake.
• In the opinion of the patient's treating physician, the patient has another condition which is significantly impairs their ability to take part in the BR.
• No access to the internet or appropriate IT equipment.

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Intervention

Other:
• Body Reprogramming
An educational intervention originally designed for patients with fibromyalgia.

Locations

Country	Name	City	State
United Kingdom	Royal Devon and Exeter Hospital	Exeter	Devon

Sponsors (3)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	Plymouth Marjon University, University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants taking part and completing week 1 of the course	This information will be used to gain insight into participants' willingness to attend four online course. Any decline in attendance will be observed, and reasons for this can be explored in the focus groups or one to one interviews.	Week 1
Primary	Percentage of participants taking part and completing week 2 of the course	See outcome 1	Week 2
Primary	Percentage of participants taking part and completing week 3 of the course.	See outcome 1	Week 3
Primary	Percentage of participants taking part and completing week 4 of the course	See outcome 1	Week 4
Primary	Number and percentage of participants who complete the study questionnaires	By capturing this information, we will determine if one of our study questionnaires is routinely unfinished by the study participants. Reasons for this can be explored during the focus groups or one to one interviews.	Baseline
Primary	Number and percentage of participants who complete the study questionnaires	See outcome 5	4 weeks
Secondary	Change in severe Asthma Questionnaire (SAQ) mean score	The new questionnaire will provide a combined assessment of disease and its treatment on the quality of life of patients with severe asthma. The scale is based on existing HRQoL scales but modified for the severe population and provides separate assessments of the effect of asthma symptoms and the effect of asthma medicines. The questionnaire has 16 items assessing experience over the last two weeks and was produced from detailed qualitative research. An additional 3 items are included to assess overall QoL during the last two weeks, and QoL during different months of the year.; The 16 items are scored from 1 - 7 and the questions concerning overall Qol, best and worst months are scored using a 0 - 100 point scale. In all cases, a higher score indicates better quality of life.	Change from baseline to post course (week 4)
Secondary	General Symptom Questionnaire (GSQ)	The GSQ is a 65 item questionnaire that was designed to measure the symptoms of patients with fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The questionnaire assesses the frequency of extra-pulmonary symptoms, such as somatic and psychological symptoms, on a 6 point Likert scale (the value scoring for each response shown in brackets): "Never or almost never" (1), "Less than 3 or 4 times per year" (2), "Every month or so" (3), "Every week or so" (4), "More than once per week" (5) or "Every day" (6). This questionnaire was used to measure the number and frequency of extra-pulmonary symptoms reported by patients. The scale measures frequency of symptoms with a higher score indicating greater symptom frequency and a worse outcome.; This questionnaire be completed by potential participants at baseline to identify those that report 8 or more non-respiratory symptoms per week and are eligible to participate	Pre-course (before enrollment on a BR course)
Secondary	Change in General Symptom Questionnaire-A score	This is an abridged General Symptom Questionnaires (GSQ) consisting of 16 non-respiratory symptoms that are associated with asthma severity. It uses the same 6 point Likert scale as the full GSQ with a higher score indicating a worse outcome.	Change from baseline to post course (week 4)
Secondary	Change in The Positive and Negative Affect Schedule (PANAS) score	This questionnaire measures positive and negative affect and consists 20 questions in total, 10 measuring positive affect and 10 measuring negative affect. Participants respond to each question by using a 5 point scale where 1 indicates "not at all" and 5 indicates "very much". A higher score for the first 10 questions indicates higher positive affect and a higher score for the next 10 questions indicates higher negative affect.	Change from baseline to post course (week 4)
Secondary	Change in the Asthma Control Questionnaire (ACQ) score	This questionnaire contains 7 items and takes into consideration FEV1% predicted and daily use of rescue bronchodilator. Patients respond to 7 items concerning their symptom severity on a 0-6 scale (0 = no impairment, 6 = maximum impairment). The questionnaire asks patients to assess their symptoms over the last week.	Change from baseline to post course (week 4)
Secondary	Global Rating of Change Questionnaire (GRCQ)	Phase one; This scale will be used by participants to indicate how much better they feel since commencing a BR. The 11-point scale ranges from -5 (a great deal worse) to 5 (A great deal better) (15). The time scale is between before the start of treatment and the current assessment.; Phase two; In this phase of the study the GRCQ will be used by participants to indicate how much better they feel since commencing a BR and a biologic treatment they recently started.	Post course (week 4)
Secondary	Friends and Family Test (FFT)	This is a one question questionnaire used throughout the NHS to assess a patient's thoughts on a health service they regularly use. The question we will use in the FFT asks "We would like you to think about your recent experience of our Body Reprogramming. How likely are you to recommend Body Reprogramming to friends and family if they needed a similar service? " Participants will respond on a 5 point scale from "Extremely Unlikely" to "Extremely Likely".	Post course (week 4)