Clinical trial NCT06419400: A Research Study to Explore the Impact of GP Support Via Text Messages to Patients With Asthma and/or COPD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
COPD
Lead sponsor: Accurx
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2024-05-17
Enrollment: 6053
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire
timeFrame: Baseline to 13 and 26 weeks
Secondary outcomes:
measure: Improved control of asthma symptoms as measured by the Asthma Control Test
timeFrame: Baseline to 13 and 26 weeks (for asthma patients)
measure: A reduction in the interval between patients requesting preventer inhaler prescriptions
timeFrame: Baseline to 13 and 26 weeks
measure: Difference in emergency admissions
timeFrame: Over 26 weeks
measure: Differences in NHS utilisation
timeFrame: Over 26 weeks
Other outcomes:
Locations:
city: Canterbury
country: United Kingdom
facility: University Medical Centre
state: Kent
city: Gravesend
country: United Kingdom
facility: Gravesend Medical Centre
state: Kent
city: Longfield
country: United Kingdom
facility: Jubilee Medical Centre
state: Kent
city: Rochester
country: United Kingdom
facility: Marlowe Park Medical Centre
state: Kent
city: Dudley
country: United Kingdom
facility: High Oak Surgery
state: West Midlands
city: Stourbridge
country: United Kingdom
facility: Lion Health
state: West Midlands
city: Worsley
country: United Kingdom
facility: Wordsley Green Health Centre
state: West Midlands
Study officials:
affiliation: Lindus Health
name: Luke Twelves
role: PRINCIPAL_INVESTIGATOR
References: