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Integrated Digitally Enhanced Care for Long-term Conditions- Asthma (IDEAL)

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ClinicalTrials.gov Identifier: NCT03511482
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Expert Health Ltd
CLAHRC Wessex
Information provided by (Responsible Party):
my mhealth Ltd

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.


Condition or disease Intervention/treatment Phase
Asthma Device: myAsthma Application Device: Lloyds Pharmacy Online Doctor Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Open Feasibility
Masking: Single (Outcomes Assessor)
Masking Description: The study will have a blinded team to perform final assesments
Primary Purpose: Supportive Care
Official Title: An Open Feasibility Study to Investigate the Impact of A Digitally Delivered Asthma Service for Patients in Primary Care (IDEAL-001: Integrated Digitally EnhAnced Care for Long-term Conditions-001
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: MyAsthma Application and Lloyds Pharmacy Online Doctor
Web based applications to support people with Asthma management
Device: Lloyds Pharmacy Online Doctor

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.


Experimental: MyAsthma Application and Usual care
Web based application to support people with Asthma Management
Device: myAsthma Application
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.

No Intervention: Usual care only (control)
Usual care of asthma management



Primary Outcome Measures :
  1. Asthma Control Test (ACT) [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Incidence of treatment emergent Adverse and Serious Adverse Events (Safety and Tolerability [ Time Frame: 12 months ]
    Safety assessed by the incidence of treatment pathway emergent adverse event (AE's) and Serious Adverse Events (SAE's) at study completion. The number of adverse events and serious adverse events will be tabulated also by the number patients reporting an event.

  2. Patient Activation Measurement (PAM) [ Time Frame: 12 months ]
    PAM is a tool used for measuring the level of patient engagement in their healthcare. It was designed to assess an individual's knowledge, skill and confidence for self-management. PAM is a 13-item scale that asks people about their beliefs, knowledge and confidence for engaging in a wide range of health behaviors and then assigns an activation score based on their responses to the 13-item scale. This will be assessed prior to and three months post intervention.

  3. Asthma Exacerbation [ Time Frame: 12 months ]
    Asthma exacerbation data will be collecting from their primary prescriber on their exacerbation history. The numbers of asthma exacerbations requiring oral antibiotics and/or oral steroids by the participants one year prior to starting the study will be recorded at visit one. If the participant has any exacerbations requiring oral antibiotics and/or steroids during the study period this will be recorded during monthly telephone contact with participants and at visit 2 .

  4. Inhaler Technique [ Time Frame: 12 months ]
    This will be assessed using the "7 Steps to successfully inhaler technique developed by the UK Inhaler Group. Each step is evaluated as being Good or Poor and the number of critical errors will be recorded.

  5. Health Care Usage [ Time Frame: 12 months ]
    Change in the median number of hospital and primary care interventions in the 6 months prior to the study and during the study period from baseline to study completion

  6. Medication Adherence [ Time Frame: 12 months ]
    Measure of primary and secondary medication adherence analysing prescription capture data, self-reported data via the MyAsthma app

  7. Lung Function [ Time Frame: 12 months ]
    Mean change in FEV1 from baseline to study completion - FEV1 will be obtained using spirometry. Spirometry will be performed at screening and end of study visit

  8. Fractional Exhaled Nitric Oxide (FENO) [ Time Frame: 12 months ]
    It is a simple breath test that measures the level of Nitric Oxide Concentration that the body naturally produces in the airways. FENo will be measured using a Bedfont device and will be performed at screening visit and end of study visit

  9. Health Economics Analysis [ Time Frame: 12 months ]
    The measurement of health outcome used will be the Quality Adjusted Life Year (QALY) calculated using the EQ5D-5L questionnaire.The EQ5D 5L is a validated questionnaire which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine.The use of NHS resources from an adjusted baseline period prior to staring the study compared to during the study will be used as a comparator for cost outcomes

  10. Patient Health Questionnaire (PHQ9) [ Time Frame: 12 month ]
    This is a self-administered validated questionnaire which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day) and has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. Validity has been assessed against an independent structured mental health professional interview. PHQ-9 greater than or equal to 10 had a sensitivity of 88% and specificity of 88% for major depression. The questionnaire can be delivered over the telephone.

  11. General Anxiety Disorder (GAD7) [ Time Frame: 12 months ]
    The GAD-7 is a self-administered validated questionnaire and is used as a screening tool and severity measure for generalised anxiety disorder The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%).

  12. Problematic Experiences of Therapy (PETS) [ Time Frame: 12 months ]
    This is a validated questionnaire which measures difficulties experienced following the advice provided by an intervention.It has 4 domains which cover: 1) Whether symptoms themselves impede ability to follow advice, or are worsened by the advice, 2) Uncertainty about how to follow the advice, 3) Doubts about the efficacy of the app or online advice and 4) Practical obstacles to following the advice such as time or opportunity.

  13. Self Efficacy for Appropriate Medication use Scale (SEAMS) [ Time Frame: 12 months ]
    Was developed by a multidisciplinary team with expertise in medication adherence and health literacy. Its psychometric properties were then evaluated among 436 patients with coronary heart disease among other comorbid conditions. Reliability was evaluated by measuring internal consistency and test-retest reliability. The final 13 item scale showed good internal consistency reliability (Cronbach's alpha= 0.89). The SEAMS is a reliable and valid instrument that may provide a valuable assessment of medication self-efficacy in chronic disease management and appears to also be appropriate for use in patients with low literacy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511482


Contacts
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Contact: Mal North +44 (0)1202 299 583 mal.north@mymhealth.com
Contact: Tom Wilkinson +44 (0)1202 299 583 tom.wilkinson@mymhealth.com

Locations
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United Kingdom
my mhealth Limited Recruiting
Bournemouth, Hampshire, United Kingdom, BH1 1JU
Contact: Mal North    1202299583    mal.north@mymhealth.com   
Sponsors and Collaborators
my mhealth Ltd
Expert Health Ltd
CLAHRC Wessex
Investigators
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Principal Investigator: Minal Bakhai Lloyds Pharmacy Online Doctor

Additional Information:
Publications of Results:
DiBello K, Boyar K, Abrenica S, Worral PS. The effectiveness of text messaging programs on adherence to treatment regimens among adults aged 18 to 45 years diagnosed with asthma: a systematic review. JBI Database of Systematic Reviews and Implementation Reports 2014;12(1):485-532.
Ofcom, Communications Marketing Report (2015)
Charlton I, White P. Asthma. Chapter 2.4. In: Jones R, Britten N, Culpepper L, Gass DA, Grol R, Mant D, et al. (eds). Oxford Textbook of Primary Medical Care, Vol. 2: clinical management. Oxford: Oxford University Press; 2004. pp. 682-90 20. Asthma UK. Annual Asthma Survey; 2016.

Other Publications:
Glaser, BG and Strauss, A. 1967. The discovery of grounded theory: Strategies for qualitative research, Chicago, IL: Aldine.
Pope C, Mays N (2006) Qualitative Research in Health Care (3rd Edition) London: BMJ Books.
Braun, V. and Clarke, V. (2006) Using thematic analysis in psychology. Qualitative Research in Psychology, 3 (2). pp. 77-101. ISSN 1478-0887 Available from: http://eprints.uwe.ac.uk/11735

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Responsible Party: my mhealth Ltd
ClinicalTrials.gov Identifier: NCT03511482     History of Changes
Other Study ID Numbers: IDEAL 001
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases