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

NCT ID: NCT06419400

Last Updated: 2024-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6053 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-11-01

Brief Summary

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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

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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.

Conditions

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Asthma COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Supportive text messages

Intervention Type BEHAVIORAL

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

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lindus Health

INDUSTRY

Sponsor Role collaborator

Accurx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luke Twelves

Role: PRINCIPAL_INVESTIGATOR

Lindus Health

Locations

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University Medical Centre

Canterbury, Kent, United Kingdom

Site Status

Gravesend Medical Centre

Gravesend, Kent, United Kingdom

Site Status

Jubilee Medical Centre

Longfield, Kent, United Kingdom

Site Status

Marlowe Park Medical Centre

Rochester, Kent, United Kingdom

Site Status

High Oak Surgery

Dudley, West Midlands, United Kingdom

Site Status

Lion Health

Stourbridge, West Midlands, United Kingdom

Site Status

Wordsley Green Health Centre

Worsley, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Accurx-001

Identifier Type: -

Identifier Source: org_study_id

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