Integrated Digitally Enhanced Care for Long-term Conditions- Asthma

NCT03511482 | Withdrawn

• 1 other identifier: IDEAL 001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a common lung condition that causes long term breathing difficulties. There is currently no cure for asthma but the use of simple inhaler treatments can keep the symptoms under control. If asthma symptoms get worse this can lead to an asthma attack which can be life-threatening. It has been shown that most of the deaths related to asthma are preventable if asthma is managed using the correct treatment plan however a significant proportion of patients are not using the right inhalers or not using them properly and do not know how to manage their asthma if it gets worse. There is currently an unmet need to develop tools that can help improve asthma care, identify high risk patients, closely monitor their asthma control in 'real time' and intervene to optimise treatment to prevent asthma attacks. Both patients and indeed, the current British Thoracic Society (BTS) asthma guidelines recognise that technology has the potential to be used to improve asthma care and could lead to reductions in National Health Service (NHS) services use and improvements in symptoms. Patients with better controlled asthma are less likely to be admitted to hospital and more likely to have an improved quality of life. This study aims to evaluate the delivery of an asthma service using an online doctor providing remote consultations paired with a self-management asthma app. The patients will use the app to input and track their symptoms, which will be monitored by a doctor remotely who can provide advice, optimise medications and intervene in a timely manner to prevent an asthma attack. The service is interactive, so the patient and doctor can communicate with one another 7 days a week by completing a consultation or sending messages via the online doctor portal or speaking on the telephone. The app will relay information about environmental triggers to the patient to help prevent the patient's asthma getting worse. The service will provide a new and potentially more convenient way of delivering routine appointments to reduce the numbers that do not attend. The patients will be able to watch educational videos stored on the app about asthma to potentially improve understanding of their condition. Digital training in inhaler technique will be supported with face to face support from pharmacists. The goals are to increase adherence to and correct use of medication, help patients self-manage dynamically to reduce their risk of an asthma attack (with solutions personalised to an individual's triggers) and equip healthcare professionals with the data to identify those people at higher risk of an attack. This is a before-and-after open interventional study, which means participants' asthma control will be compared before and after using the digital asthma management service. It is not a randomised study and participants will be given the choice of using a digital service. It is a single-centre study which will take place within one Clinical Commissioning Group (CCG) in Hampshire (UK), across at least two GP surgeries. It is anticipated that approximately 80 patients will be recruited. Patients will be provided with this digital asthma service for a period of 6 months of 2018 and outcomes will be measured using a combination of questionnaires (quality of life, patient satisfaction, level of activation) and quantitative measures such as Forced Expired Volume over 1 second (FEV1)(measure of airway obstruction), Fractional Exhaled Nitric Oxide (FENO) (measure of airway inflammation) and Asthma Control Test Scores (measure of symptom control). Feedback from NHS professionals hosting the study and online doctors will also be sought. A Health economic model will be generated comparing the digitally enhanced model versus usual care. The main outcome of this study is looking at whether this new model of service delivery can provide an improvement in asthma control test scores.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test (ACT)

  The ACT is a validated self administered questionnaire used to evaluate asthma control.ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning

  12 months

Secondary Outcomes (13)

• Incidence of treatment emergent Adverse and Serious Adverse Events (Safety and Tolerability

  12 months

• Patient Activation Measurement (PAM)

  12 months

• Asthma Exacerbation

  12 months

• Inhaler Technique

  12 months

• Health Care Usage

  12 months

Study Arms (3)

MyAsthma Application and Lloyds Pharmacy Online Doctor

EXPERIMENTAL

Web based applications to support people with Asthma management

Device: Lloyds Pharmacy Online Doctor

MyAsthma Application and Usual care

EXPERIMENTAL

Web based application to support people with Asthma Management

Device: myAsthma Application

Usual care only (control)

NO INTERVENTION

Usual care of asthma management

Interventions

myAsthma Application DEVICE

myAsthma Application is a Multi facetted online self management tool developed by my mhealth Ltd, which is an online interface for patient to feedback symptoms and (Quality of Life) QoL score. The app consists of an online action /self management plan, Patient education videos, medication diary, Peak Flow diary, Inhaler technique videos, mindfulness videos as well as weather and Pollution forecasters.

MyAsthma Application and Usual care

Lloyds Pharmacy Online Doctor DEVICE

Online Doctor is part of Expert Health Ltd a doctor-led initiative providing safe and reliable remote online healthcare to adults in the UK. Their patient-centred model of healthcare allows patients to tailor care around their schedule and increases healthcare access for harder-to-reach patient groups. As the first ever online healthcare organisation to register with the government regulator of healthcare - and having received outstanding feedback from the Care Quality Commission about the high level of safe, effective, caring, responsive and well led care provided by the service - They pride themselves on their pioneer status and work constantly to expand the boundaries of personalised healthcare.

MyAsthma Application and Lloyds Pharmacy Online Doctor

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years and over
• Able to give written informed consent
• A clinical diagnosis of Asthma on regular inhaled medication
• Measures of poor asthma control: Oral steroid use in the last 12 months and /or ACT score of less than 20 at screening, and/or use of 6 or more short acting beta-agonist inhalers in the last 6 months and/or frequent symptoms and/or (Accident and Emergency) A+E or hospital admission for asthma
• Access to the internet at home, use of mobile technology and the ability to operate a web platform in English
• No plans to travel abroad for prolonged periods during the trial period
• Consent to be contacted by phone, text and email

You may not qualify if:

• Asthma exacerbation in the past 4-6 weeks (Baseline visit to be delayed)
• Patients who have a significant medical comorbidity that can present with asthma type symptoms e.g. COPD, Heart Failure, Lung Cancer (these cases require physical examination and a remote assessment would not be appropriate)
• Terminal Illness Pregnant
• Breast Feeding
• Patients who have another medical condition, including but not limited to respiratory immunological or cardiac disease other than asthma deemed by the investigators as significant
• Diagnosis of Occupational Asthma
• Patients on long term oral steroids or theophylline, as these treatments are not provided by the online doctor service
• Previous Intensive Therapy Unit (ITU) admission for asthma
• Patients under routine follow up of secondary care for asthmaHousebound
• Patients who are unable to read or use an internet-enabled device
• Alcohol and drug misuse
• Patients deemed unsuitable by their GP
• Patients who have another medical treatment(s), including but not limited to beta blockers deemed unsuitable by the investigators.
• Already using a self management app.

Sponsors & Collaborators

• my mhealth Ltd: lead
• Expert Health Ltd: collaborator
• CLAHRC Wessex: collaborator

Study Sites (1)

my mhealth Limited

Bournemouth, Hampshire, BH1 1JU, United Kingdom

Location

Related Publications (32)

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  RESULT

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Minal Bakhai

  Lloyds Pharmacy Online Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will have a blinded team to perform final assesments
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Feasibility

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 27, 2018
• Study Start: March 8, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: August 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)