A Research Study to Explore the Impact of GP Support Via Text Messages to Patients With Asthma and/or COPD

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06419400
• Other study ID #: Accurx-001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: May 2024
• Source: Accurx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6053
• Est. completion date: November 1, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Behavioral:
• Supportive text messages
The intervention group will receive a series of supportive text messages over the 6 month trial period, varying in content and frequency.

Locations

Country	Name	City	State
United Kingdom	University Medical Centre	Canterbury	Kent
United Kingdom	High Oak Surgery	Dudley	West Midlands
United Kingdom	Gravesend Medical Centre	Gravesend	Kent
United Kingdom	Jubilee Medical Centre	Longfield	Kent
United Kingdom	Marlowe Park Medical Centre	Rochester	Kent
United Kingdom	Lion Health	Stourbridge	West Midlands
United Kingdom	Wordsley Green Health Centre	Worsley	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
Accurx	Lindus Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improved control of asthma symptoms as measured by the Asthma Control Test	Changes in the Asthma Control Test	Baseline to 13 and 26 weeks (for asthma patients)
Secondary	A reduction in the interval between patients requesting preventer inhaler prescriptions	Reduction in days between consecutive preventer inhaler prescription requests	Baseline to 13 and 26 weeks
Secondary	Difference in emergency admissions	Differences in the number of emergency admissions between the intervention and control group	Over 26 weeks
Secondary	Differences in NHS utilisation	Differences in the utilisation of NHS resources between the intervention and control group	Over 26 weeks