AsthmaNCT06419400
A Research Study to Explore the Impact of GP Support Via Text Messages to Patients With Asthma and/or COPD
A study testing Supportive text messages in people with Asthma and COPD, run by Accurx at 7 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Supportive text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,053 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 1 Apr 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to understand the study procedures
- Inability or reluctance to provide responses to the study questionnaires
- Inability to receive and respond to text messages
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
University Medical Centre
Canterbury, Kent, CT2 7PB
High Oak Surgery
Dudley, West Midlands
Gravesend Medical Centre
Gravesend, Kent, DA12 2EN
Jubilee Medical Centre
Longfield, Kent, DA3 7QD
Marlowe Park Medical Centre
Rochester, Kent, ME2 2PW
Lion Health
Stourbridge, West Midlands, DY8 3SS
Wordsley Green Health Centre
Worsley, West Midlands, DY8 5PD
About this study
Official title: 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)
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
Read the detailed description
This trial will be a 6-month prospective, randomised controlled trial in which the study population is randomly allocated (1:1) to an intervention or control group. The trial is multicentre and is non-blind. All patients in both groups will continue to receive their usual care for the duration of the study. Randomisation will be at the individual level. Participants will be randomly allocated as per a computer-generated randomisation list using a random number generator as part of the Microsoft .NET framework.
This is a behavioural intervention. The intervention will consist of a series of supportive text messages to patients from their GP practice over a 6 month period. The messages will vary in frequency from 2 or 3 in the first weeks of the trial to only 1 or 2 a month in the final months of the trial. The content of the messages will vary; some will contain information about how to use a preventer inhaler, some will emphasise the importance of using it, and some will provide simple reminders to patients to take their inhaler.
All participants will continue to receive their usual care throughout the duration of the study; the text message intervention with be in addition to their usual care.
- Being tested
- Supportive text messages
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive text messagesBehavioural
The intervention group will receive a series of supportive text messages over the 6 month trial period, varying in content and frequency.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Text Messagses | Experimental | The 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). Receives: Behavioral: Supportive text messages |
| Control Group | No intervention | The 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire
Changes in the MARS-5 Questionnaire
Measured: Baseline to 13 and 26 weeks
Secondary outcomes (4)
Improved control of asthma symptoms as measured by the Asthma Control Test
Changes in the Asthma Control Test
Measured: Baseline to 13 and 26 weeks (for asthma patients)
A reduction in the interval between patients requesting preventer inhaler prescriptions
Reduction in days between consecutive preventer inhaler prescription requests
Measured: Baseline to 13 and 26 weeks
Difference in emergency admissions
Differences in the number of emergency admissions between the intervention and control group
Measured: Over 26 weeks
Differences in NHS utilisation
Differences in the utilisation of NHS resources between the intervention and control group
Measured: Over 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Apr 2022
- Primary completion15 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accurx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
- Investigators
- Luke Twelves, Principal investigator, Lindus Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419400
- Sponsor's protocol ID
- Accurx-001
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06419400
- Acronym / sponsor ID
- Accurx-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,053 participants (actual)
- Lead sponsor
- AccurxIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This trial will be a 6-month prospective, randomised controlled trial in which the study population is randomly allocated (1:1) to an intervention or control group. The trial is multicentre and is non-blind. All patients in both groups will continue to receive their usual care for the duration of the study. Randomisation will be at the individual level. Participants will be randomly allocated as per a computer-generated randomisation list using a random number generator as part of the Microsoft .NET framework.
This is a behavioural intervention. The intervention will consist of a series of supportive text messages to patients from their GP practice over a 6 month period. The messages will vary in frequency from 2 or 3 in the first weeks of the trial to only 1 or 2 a month in the final months of the trial. The content of the messages will vary; some will contain information about how to use a preventer inhaler, some will emphasise the importance of using it, and some will provide simple reminders to patients to take their inhaler.
All participants will continue to receive their usual care throughout the duration of the study; the text message intervention with be in addition to their usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Text Messagses | Experimental | Behavioral: Supportive text messagesThe 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 intervention | –The 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to understand the study procedures
- Inability or reluctance to provide responses to the study questionnaires
- Inability to receive and respond to text messages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive text messagesThe intervention group will receive a series of supportive text messages over the 6 month trial period, varying in content and frequency. | Behavioural | Supportive Text Messagses |
Primary outcome
Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire
Time frame: Baseline to 13 and 26 weeks
Changes in the MARS-5 Questionnaire
4 secondary outcomes
Improved control of asthma symptoms as measured by the Asthma Control Test
Time frame: Baseline to 13 and 26 weeks (for asthma patients)
A reduction in the interval between patients requesting preventer inhaler prescriptions
Time frame: Baseline to 13 and 26 weeks
Difference in emergency admissions
Time frame: Over 26 weeks
Differences in NHS utilisation
Time frame: Over 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Twelves principal investigator
Lindus Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive text messages in people with Asthma and COPD, run by Accurx at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire (time frame: Baseline to 13 and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.