Asthma, COPD
Conditions
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
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.
Interventions
BEHAVIORALSupportive text messages
The intervention group will receive a series of supportive text messages over the 6 month trial period, varying in content and frequency.
Sponsors
Lindus Health
Accurx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide informed consent and to comply with the study instructions 2. Male and females age 18 or older 3. Confirmed diagnosis of asthma and/or COPD as recorded in the patient's GP medical record 4. Currently prescribed a preventer inhaler 5. Access to a mobile phone 6. Ability to check text messages on phone 7. Ability to read
Exclusion criteria
1. Inability to understand the study procedures 2. Inability or reluctance to provide responses to the study questionnaires 3. Inability to receive and respond to text messages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire | Baseline to 13 and 26 weeks | Changes in the MARS-5 Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved control of asthma symptoms as measured by the Asthma Control Test | Baseline to 13 and 26 weeks (for asthma patients) | Changes in the Asthma Control Test |
| A reduction in the interval between patients requesting preventer inhaler prescriptions | Baseline to 13 and 26 weeks | Reduction in days between consecutive preventer inhaler prescription requests |
| Difference in emergency admissions | Over 26 weeks | Differences in the number of emergency admissions between the intervention and control group |
| Differences in NHS utilisation | Over 26 weeks | Differences in the utilisation of NHS resources between the intervention and control group |
Countries
United Kingdom
Outcome results
None listed