A Research Study to Explore the Impact of GP Support Via Text Messages to Patients With Asthma and/or COPD
A Randomised Controlled Trial to Evaluate the Impact of Supportive Text Messages From GP Practices on Self-reported Symptoms and Inhaler Adherence in Patients With Asthma and/or Chronic Obstructive Pulmonary Disease (COPD) Who Have Been Prescribed a Preventer (Daily) Inhaler (Inhaler Trial)
1 other identifier
interventional
6,053
1 country
7
Brief Summary
A 6-month randomised controlled trial to evaluate the impact of text message support on symptom control and inhaler adherence for patients with asthma and/or COPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Apr 2022
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedMay 20, 2024
May 1, 2024
1.5 years
May 14, 2024
May 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire
Changes in the MARS-5 Questionnaire
Baseline to 13 and 26 weeks
Secondary Outcomes (4)
Improved control of asthma symptoms as measured by the Asthma Control Test
Baseline to 13 and 26 weeks (for asthma patients)
A reduction in the interval between patients requesting preventer inhaler prescriptions
Baseline to 13 and 26 weeks
Difference in emergency admissions
Over 26 weeks
Differences in NHS utilisation
Over 26 weeks
Study Arms (2)
Supportive Text Messagses
EXPERIMENTALThe intervention group will receive a series of supportive text messages over the 6 month trial period, varying in content and frequency. They will also be asked to provide self reported data on their symptoms and their adherence at 3 points in time (start, mid-point, and end of trial).
Control Group
NO INTERVENTIONThe control group will receive no supportive text messages over the period of the trial. They will be asked to only provide self reported data on their symptoms and their adherence at 3 points in time (start, mid-point, and end of trial).
Interventions
The intervention group will receive a series of supportive text messages over the 6 month trial period, varying in content and frequency.
Eligibility Criteria
You may qualify if:
- Willing and able to provide informed consent and to comply with the study instructions
- Male and females age 18 or older
- Confirmed diagnosis of asthma and/or COPD as recorded in the patient's GP medical record
- Currently prescribed a preventer inhaler
- Access to a mobile phone
- Ability to check text messages on phone
- Ability to read
You may not qualify if:
- Inability to understand the study procedures
- Inability or reluctance to provide responses to the study questionnaires
- Inability to receive and respond to text messages
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Accurxlead
- Lindus Healthcollaborator
Study Sites (7)
University Medical Centre
Canterbury, Kent, CT2 7PB, United Kingdom
Gravesend Medical Centre
Gravesend, Kent, DA12 2EN, United Kingdom
Jubilee Medical Centre
Longfield, Kent, DA3 7QD, United Kingdom
Marlowe Park Medical Centre
Rochester, Kent, ME2 2PW, United Kingdom
High Oak Surgery
Dudley, West Midlands, United Kingdom
Lion Health
Stourbridge, West Midlands, DY8 3SS, United Kingdom
Wordsley Green Health Centre
Worsley, West Midlands, DY8 5PD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luke Twelves
Lindus Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 17, 2024
Study Start
April 1, 2022
Primary Completion
September 15, 2023
Study Completion
November 1, 2023
Last Updated
May 20, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share