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Completed

NCT Number: NCT06419400

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre, Canterbury, Kent, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to provide informed consent and to comply with the study instructions
  • Male and females age 18 or older
  • Confirmed diagnosis of asthma and/or COPD as recorded in the patient's GP medical record
  • Currently prescribed a preventer inhaler
  • Access to a mobile phone
  • Ability to check text messages on phone
  • Ability to read

Exclusion criteria

  • Inability to understand the study procedures
  • Inability or reluctance to provide responses to the study questionnaires
  • Inability to receive and respond to text messages

Treatment and study plan

Supportive Text messages

Behavioral

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

Primary outcomes

  1. Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire

    Time frame: Baseline to 13 and 26 weeks

    Changes in the MARS-5 Questionnaire

Secondary outcomes

  1. Improved control of asthma symptoms as measured by the Asthma Control Test

    Time frame: Baseline to 13 and 26 weeks (for asthma patients)

    Changes in the Asthma Control Test

  2. A reduction in the interval between patients requesting preventer inhaler prescriptions

    Time frame: Baseline to 13 and 26 weeks

    Reduction in days between consecutive preventer inhaler prescription requests

  3. Difference in emergency admissions

    Time frame: Over 26 weeks

    Differences in the number of emergency admissions between the intervention and control group

  4. Differences in NHS utilisation

    Time frame: Over 26 weeks

    Differences in the utilisation of NHS resources between the intervention and control group

Sponsors and collaborators

Lead sponsor

Accurx

Industry

Collaborators

  • Lindus Health

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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