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

Not Applicable

Completed

• Conditions: COPD; Asthma
• Interventions: Behavioral: Supportive text messages

• Registration Number: NCT06419400
• Lead Sponsor: Accurx

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.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2023-09-15
• Study Completion: 2023-11-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6053

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Text Messagses	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. 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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (7)

High Oak Surgery; 🇬🇧 Dudley, West Midlands, United Kingdom

Lion Health; 🇬🇧 Stourbridge, West Midlands, United Kingdom

Wordsley Green Health Centre; 🇬🇧 Worsley, West Midlands, United Kingdom

Gravesend Medical Centre; 🇬🇧 Gravesend, Kent, United Kingdom

University Medical Centre; 🇬🇧 Canterbury, Kent, United Kingdom

Marlowe Park Medical Centre; 🇬🇧 Rochester, Kent, United Kingdom

Jubilee Medical Centre; 🇬🇧 Longfield, Kent, United Kingdom