Asthma Clinical Trial
— COM-BOfficial title:
The Use of the COM-B Questionnaire to Determine the Psychological and Behavioural Barriers to Adherence in Patients With Asthma
NCT number | NCT05643924 |
Other study ID # | 300735 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 24, 2022 |
Est. completion date | February 24, 2025 |
Verified date | November 2022 |
Source | Portsmouth Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Asthma is a common lung condition that cannot be cured, although usually it can be effectively controlled with available treatments. Yet, it is well recognised that 70% of patients are non-adherent to their asthma treatment. Personalising treatment by offering the most relevant interventions based on the patient's psychological/behavioural needs results in great success. However, health care providers have limited available resources to deliver a patient-centred approach to their psychological/behavioural needs, resulting in a current one-size-fits-all strategy due to the non-feasible nature of existing surveys. The solution would be to provide health care professionals with a clinically feasible questionnaire that identifies the patients personal psychological/behavioural factors to adherence.
Status | Recruiting |
Enrollment | 146 |
Est. completion date | February 24, 2025 |
Est. primary completion date | February 24, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged 18 years or over - Willing and able to give informed consent for participation in the study. - Diagnosis of asthma confirmed by a healthcare professional and requiring maintenance asthma treatment, including an inhaled corticosteroid Exclusion Criteria: - Unable to comprehend the study and provide informed consent, e.g., insufficient command of English in the absence of someone who can adequately interpret. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Portsmouth Hospitals University NHS Trust | Portsmouth | Hampshire |
Lead Sponsor | Collaborator |
---|---|
Portsmouth Hospitals NHS Trust | University of Portsmouth |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploring the associations between the COM-B questionnaire responses and asthma phenotype, including clinical, biological, psychosocial and behavioural components | Compare responses between capability, opportunity and motivation (COM-B components) with variables including (but not limited to): Type of asthma (T2 or non-T2 defined by the presence of a T2 inflammatory signal assessed using FeNO and/or peripheral blood eosinophil count) Asthma severity using BTS/SIGN stage Level of asthma control assessed using the ACQ6 questionnaire (a score of =1.5 reflects poor asthma control and number of severe exacerbations in preceding 12 months Quality of life measured using the mini AQLQ score Number of co-morbidities The complexity of treatment (number of inhaled doses/day, total number of medications taken each day) Item responses from the digital readiness questionnaire |
3 Years | |
Other | Explore the associations between the COM-B questionnaire responses and digital readiness | Compare responses between capability, opportunity and motivation (COM-B components) and scores of the digital readiness scale. Low COM-B questionnaire scores indicate that interventions are needed, and low digital readiness scores indicate that the individual will struggle with digital technology. | 3 Years | |
Primary | Can the COM-B questionnaire detect a patient's perceived psychological and behavioural barriers to adherence | Comparisons of the (1) short COM-B questionnaire (2) 61-item Theoretical Domain Framework Questionnaire to assess content validity. A low score on the COM-B questionnaire and the Theoretical Domains Framework Questionnaire indicates that the individual is experiencing a barrier based on that source of behaviour domain. | 3 Years | |
Secondary | Can the COM-B questionnaire be used in a clinical asthma pathway? | The total number of questionnaires distributed and the proportion of completed questionnaires compared to the 61-item Theoretical Domain Framework Questionnaire and the asthma control questionnaire (ACQ). | 3 Years | |
Secondary | To explore the key psychological and behavioural barriers indicated by the COM-B questionnaire and adherence to treatment in patients with confirmed asthma with heterogenous severity | Compare responses between capability, opportunity and motivation (COM-B components) with levels of adherence measured by: 1) Medicines Possession Ratio (MPR) |
3 Years |
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