NCT05643924

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

November 21, 2022

Last Update Submit

November 12, 2024

Conditions

Keywords

AsthmaAdherenceBehaviour and psychological barriersCOM-BInhalerTheoretical Domains FrameworkBehaviour change

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Can the COM-B questionnaire be used in a clinical asthma pathway?

    3 Years

  • 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

    3 Years

Other Outcomes (2)

  • Exploring the associations between the COM-B questionnaire responses and asthma phenotype, including clinical, biological, psychosocial and behavioural components

    3 Years

  • Explore the associations between the COM-B questionnaire responses and digital readiness

    3 Years

Study Arms (1)

Patients diagnosed with Asthma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All people with a diagnosis of asthma, under the care of the asthma service at Portsmouth Hospitals University NHS Trust will be invited to participate in this study. This will include recruitment from both primary and secondary care sites. In addition, both outpatients and inpatients will be approached and invited to participate.

You may qualify if:

  • 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

You may not qualify if:

  • Unable to comprehend the study and provide informed consent, e.g., insufficient command of English in the absence of someone who can adequately interpret.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals University NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (1)

  • Munns A, Wiffen L, Brown T, Fasulo A, Chauhan M, D'Cruz L, Kaklamanou D, Chauhan AJ. Capability, Opportunity, and Motivation Model for Behavior Change in People With Asthma: Protocol for a Cross-Sectional Study. JMIR Res Protoc. 2023 Jul 6;12:e44710. doi: 10.2196/44710.

MeSH Terms

Conditions

AsthmaBehavior

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 9, 2022

Study Start

February 24, 2022

Primary Completion

September 26, 2022

Study Completion

October 24, 2022

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations