Trial of E-Health Platform Supported Care vs Usual Care After Exacerbation of COPD

NCT02706600 | Completed

• 1 other identifier: PHT/2015/039
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms such as chronic cough, breathlessness and reduced tolerance to exercise. National Institute for Health and Care Excellence (NICE) recommends that patients with COPD have a self management plan (SMP). The utilisation of SMP's has been shown to reduce healthcare utilisation, improve quality of life, and reduces the need for hospitalisation. Currently SMP's are delivered to patient in a paper format, myCOPD is a web based self management system which has been developed by Healthcare professional and patients encompasses the principles of Self management and offers a viable solution to a national recommendation. The study will compare paper self management plans against the online version myCOPD. The study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital for an exacerbation or flare up of their COPD. Patients will be given an information sheet during their admission and prior to leaving hospital be asked if they wish to participate in the study. Patients will participate in the study for no less than two months and a maximum of three months. 30 patients will receive written self management and 30 will receive online self management. There will be a total of 4 visits for the duration of the study. The screening visits will comprise of written or verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler technique assessment and delivery of either a written self management plan. The telephone visits will comprise of verbal consent and completion of the COPD Assessment Test. The End of Study visit will comprise of verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler technique.

Conditions

Chronic Obstructive Pulmonary Diseases

Outcome Measures

Primary Outcomes (2)

• COPD Assessment Test (CAT)

  This is a validated symptom scoring system used in COPD studies9 The CAT questionnaire contains eight questions and provides a reliable measure of the impact of COPD on health status. Patients read the two statements for each item, which describe the best and worst scenario, (e.g I never cough - I cough all the time), and decide where on the scale of 0-5 they fit. The maximum score is out of 40. The higher the CAT score the greater the impact of symptoms on their health status. Experts involved in the development of CAT suggest that any change of 2 or more in the patient's final score may indicate a clinically significant change. CAT will be recorded at the start prior to any intervention at visit one and 3 months post intervention at visit 4

  3 months

• Inhaler technique

  As different inhaled medication devices require different techniques, each participant's inhaler technique will be assessed according to manufactures guidelines for each device and critical errors recorded. Their technique will be video recorded at visit one and visit two. Any changes to devices during the study will be recorded prior to starting any new treatment. Each participant's technique will be evaluated and the number of critical errors recorded for each device and a composite . Each device will have its own critical error list we have created based on manufactures guidelines. Participants technique will be videoed and assessed using a critical error list for each device by a Health care Professional. This assessment will take place at visit one prior to intervention and 3 months post intervention at visit 4. The difference in the number of errors for each device pre and post intervention will then be recorded.

  3 months

Secondary Outcomes (8)

• St Georges Respiratory Questionnaire (SGRQ)

  3 months

• modified MRC

  3 months

• Hospital Anxiety and Depression Score (HAD)

  3 months

• Patient Activation Measure (PAM)

  3 months

• Work Productivity Activity Impairment (WPAI)

  3 months

Study Arms (2)

Written Self Management

OTHER

The HealthQuest written self management plan was produced in 2013. It is a one page document which contains a written self management plan which can be individualised for the patient. It consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate.

Behavioral: Written Self management plan

Online Self Management

ACTIVE COMPARATOR

myCOPD is a system that can be accessed by patients using any device that can connect to the internet and can operate in any internet browser. It contains: Educational information, Inhaler technique videos explaining the correct technique required to use different inhaler devices licensed for use in people with COPD. Medication and symptom diaries. Appointment diary, pulmonary rehabilitation videos to promote and support exercises that can be done in the home. Oxygen Alert Card - Users can create their own oxygen alert card online A 5 Day local weather and pollution reports - Feed for reports come from the met office and DEFRA. A Self management plan, which consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. The action plan is populated automatically with the information input by the patients.

Behavioral: myCOPD

Interventions

myCOPD BEHAVIORAL

myCOPD is a system that can be accessed by patients using any device that can connect to the internet and can operate in any internet browser. It contains: Educational information, Inhaler technique videos explaining the correct technique required to use different inhaler devices licensed for use in people with COPD. Medication and symptom diaries. Appointment diary Bitesize pulmonary rehabilitation videos designed to promote and support exercises that can be done in a home setting. Oxygen Alert Card - Users can create their own oxygen alert card online A 5 Day local weather and pollution reports - Feed for reports come from the met office and DEFRA. A Self management plan, which consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. The action plan is populated automatically with the information input by the patients.

Online Self Management

Written Self management plan BEHAVIORAL

The HealthQuest written self management plan was produced in 2013. It is a one page document which contains a written self management plan which can be individualised for the patient. It consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate.

Written Self Management

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects able to complete all study procedures and give written informed consent.
• A diagnosis of COPD defined as per the NICE COPD guidelines
• Male or female volunteers aged 45+ admitted to hospital or the ambulatory care service with a primary diagnosis of acute exacerbation of COPD
• Patients who are taking inhaled therapies for COPD
• Current or ex-smokers with a pack year history of more than 10 years
• Access to the internet and ability to operate web platform and or use written action plan

You may not qualify if:

• Patients who have any another respiratory disease as their main complaint such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
• Patients unable to read or use an Internet enabled device.
• Patients with any uncontrolled medical condition which in the view of the principle investigator or their team would confound the impact of a COPD directed support tool.

Sponsors & Collaborators

• my mhealth Ltd: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (1)

Portsmouth Hospital NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (6)

• Rice KL, Dewan N, Bloomfield HE, Grill J, Schult TM, Nelson DB, Kumari S, Thomas M, Geist LJ, Beaner C, Caldwell M, Niewoehner DE. Disease management program for chronic obstructive pulmonary disease: a randomized controlled trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):890-6. doi: 10.1164/rccm.200910-1579OC. Epub 2010 Jan 14.

  PMID: 20075385 BACKGROUND

• Bourbeau J, Bartlett SJ. Patient adherence in COPD. Thorax. 2008 Sep;63(9):831-8. doi: 10.1136/thx.2007.086041.

  PMID: 18728206 BACKGROUND

• Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

  PMID: 19720809 BACKGROUND

• Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.

  PMID: 1759018 BACKGROUND

• Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.

  PMID: 23258783 BACKGROUND

• Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.

  PMID: 12622605 RESULT

Related Links

• NICE (2010). National guidelines for the management of COPD in adults in primary and secondary care.
• Department of Health (2012) An Outcomes Strategy for COPD and Asthma: NHS Companion Document.
• Consultation on a strategy for services for chronic obstructive pulmonary disease (COPD) in England.
• 4 National Institute for Health and Care Institute (2011) guidance.nice.org.uk

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Green, Dr

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: March 11, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2015-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)