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

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

Study Overview

• Status: Completed
• Conditions: Asthma; COPD
• Intervention / Treatment: Behavioral: Supportive text messages

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 Type: Interventional
• Enrollment (Actual): 6053
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Canterbury, Kent, United Kingdom, CT2 7PB
      • University Medical Centre
    • Gravesend, Kent, United Kingdom, DA12 2EN
      • Gravesend Medical Centre
    • Longfield, Kent, United Kingdom, DA3 7QD
      • Jubilee Medical Centre
    • Rochester, Kent, United Kingdom, ME2 2PW
      • Marlowe Park Medical Centre
  • West Midlands
    • Dudley, West Midlands, United Kingdom
      • High Oak Surgery
    • Stourbridge, West Midlands, United Kingdom, DY8 3SS
      • Lion Health
    • Worsley, West Midlands, United Kingdom, DY8 5PD
      • Wordsley Green Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Text Messagses; 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).	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.
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
Difference in emergency admissions	Differences in the number of emergency admissions between the intervention and control group	Over 26 weeks
Differences in NHS utilisation	Differences in the utilisation of NHS resources between the intervention and control group	Over 26 weeks

Collaborators and Investigators

• Sponsor: Accurx
• Collaborators: Lindus Health
• Investigators: Principal Investigator: Luke Twelves, Lindus Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Accurx-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No