## Protocol Section
### Identification Module
**NCT ID:** NCT06419400

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

**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)

#### Organization Study ID Info
**ID:** Accurx-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Accurx
### Status Module
#### Completion Date
**Date:** 2023-11-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-15

**Type:** ACTUAL

#### Start Date
**Date:** 2022-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Lindus Health

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Accurx

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Asthma

- COPD

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6053

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Behavioral: Supportive text messages

**Label:** Supportive Text Messagses

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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).

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Supportive Text Messagses

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

**Name:** Supportive text messages

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in the MARS-5 Questionnaire

**Measure:** 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

#### Secondary Outcomes

**Description:** Changes in the Asthma Control Test

**Measure:** Improved control of asthma symptoms as measured by the Asthma Control Test

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

**Description:** Reduction in days between consecutive preventer inhaler prescription requests

**Measure:** A reduction in the interval between patients requesting preventer inhaler prescriptions

**Time Frame:** Baseline to 13 and 26 weeks

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

**Measure:** Difference in emergency admissions

**Time Frame:** Over 26 weeks

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

**Measure:** Differences in NHS utilisation

**Time Frame:** Over 26 weeks

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Canterbury

**Country:** United Kingdom

**Facility:** University Medical Centre

**State:** Kent

**Zip:** CT2 7PB

**Location 2:**

**City:** Gravesend

**Country:** United Kingdom

**Facility:** Gravesend Medical Centre

**State:** Kent

**Zip:** DA12 2EN

**Location 3:**

**City:** Longfield

**Country:** United Kingdom

**Facility:** Jubilee Medical Centre

**State:** Kent

**Zip:** DA3 7QD

**Location 4:**

**City:** Rochester

**Country:** United Kingdom

**Facility:** Marlowe Park Medical Centre

**State:** Kent

**Zip:** ME2 2PW

**Location 5:**

**City:** Dudley

**Country:** United Kingdom

**Facility:** High Oak Surgery

**State:** West Midlands

**Location 6:**

**City:** Stourbridge

**Country:** United Kingdom

**Facility:** Lion Health

**State:** West Midlands

**Zip:** DY8 3SS

**Location 7:**

**City:** Worsley

**Country:** United Kingdom

**Facility:** Wordsley Green Health Centre

**State:** West Midlands

**Zip:** DY8 5PD

#### Overall Officials

**Official 1:**

**Affiliation:** Lindus Health

**Name:** Luke Twelves

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Misc Info Module

- Version Holder: 2024-05-31
