Clinical trial NCT02706613: Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD
Official title: A Randomised Controlled Research Study Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Diseases
Lead sponsor: my mhealth Ltd
Sponsor class: INDUSTRY
Collaborators: name: Portsmouth Hospitals NHS Trust
First posted: 2016-03-11
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over time, patients with COPD (Chronic Obstructive Pulmonary Disease) develop progressive symptoms of breathlessness, which can limit day-to-day activities and tolerance to exercise. Pulmonary Rehabilitation (PR) is an established intervention in the management of COPD and is a structured programme of exercise training and education. Pulmonary Rehabilitation encourages and enables patients to improve their exercise capacity incrementally over the course of a six-week programme. An established evidence base has placed PR at the centre of interventions for COPD and its provision is mandated by NICE as a key pillar of integrated care.

Currently, the provision of PR in the NHS is limited to group sessions run over an established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise capacity, access to PR classes can be problematic for some patients. Also, staff and facility resources limit delivering the programme at scale. An online PR programme developed by my mhealth known as 'myPR', in consultation with patients and physiotherapy experts, offers an alternative provision of this important intervention.

The study aims to compare this online PR programme to conventional face-to-face PR as currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from Portsmouth Hospital and local Participant Identification Centres.They will then be assessed for suitability onto PR, consented and randomised onto an arm of the study. 36 will undertake a conventional PR programme as reflected in the NHS, and 70 the online PR programme known as 'myPR'. Pre and post programme measurements including walking distance and quality of life questionnaires will then be compared between each arm of the trial, to ensure that the online PR is not inferior to the conventional face-to-face PR.

Detailed description: Everyone with Chronic Obstructive Pulmonary Disease (COPD) who is able to exercise should be offered pulmonary rehabilitation (PR). Participants will be invited to take part in the study after being referred for PR by members of Queen Alexandra Hospital (QAH), Portsmouth Hospitals NHS Trust clinical team. They will be given a PIS for the patient to contact the study team to arrange an appointment, or alternatively if verbal consent is obtained the research team will contact the patient to arrange an assessment appointment. Potential participants will also be identified from databases from selected GP who meet the protocol inclusion and exclusion criteria. These potential participants will be sent a study participation invitation letter and asked to contact the respiratory research team at QAH to arrange an assessment appointment.

If a participant decides they would like to take part and contacts the respiratory research team or have been contacted by the team, an initial appointment will be arranged. This will take part at the participants home, GP surgery or Queen Alexandra Hospital depending on the patients choice. After obtaining consent, suitability for inclusion onto pulmonary rehabilitation will be assessed. A full medical history (including confirmation of diagnosis, COPD severity, smoking history, medications and current activity) along with blood pressure will be taken to assess for any exclusion criteria. The timed "Up and Go" Test will also be performed to assess safety of mobility and exercising. This is to ensure it is safe for the participant to exercise independently. If a participant does not meet the inclusion criteria, they will be referred back to their GP with the reason they were not suitable for PR. It is explained to the participant that they can withdraw from the study at any point and that this will not affect their care. If a participant decides they do not wish to be included onto the study they will be referred to the conventional NHS PR programme. If a participant is suitable for PR and is willing to participate, further screening is undertaken. This can take place immediately if this initial appointment is carried out at QAH, or a further appointment will be arranged at QAH will be arranged.

The next stage of the assessment (this may be a further appointment (visit 2) if the initial assessment was not carried out a QAH) will take place at Queen Alexandra Hospital where the space is available to carry out the assessments. Transport can be provided to this venue if required. Consent will first be obtained and participants will then complete the first of two walking test for 6 minutes to measure how far they can walk, known as the six-minute walking test . Oxygen levels will be measured using a probe that fits on the finger and if significant oxygen desaturation is noted, the participant will be withdrawn from the study and referred onto the local oxygen assessment centre. The participant will be asked to fill out four health- related questionnaires and they will then repeat the six minute walking test and the best of the two tests will be recorded.

If the participant is suitable to undertake a PR programme they will then be randomised to either receive the online PR 'my PR', or the conventional face-to-face PR. Randomisation will be undertaken by an online randomisation system hosted by my mhealth.

Participants randomised to receive the conventional PR will be given 12 visit dates (twice a week for six weeks) at the PR venue where the face-to-face sessions will take place. This attendance length and frequency is standard for PR. The components of the PR programme will include an exercise programme, including a warm-up and cool- down programme. Education sessions will also be provided and includes anatomy of the lungs and what is COPD, anxiety and depression, claiming benefits, self management, managing breathlessness, medications and treatments, managing exacerbations of COPD and chest infections, clearing sputum and the Active Cycle of Breathing Technique, nutrition, pacing, smoking cessation and advice on travel with COPD. Participants on the face to face arm will also be instructed to carry out the pulmonary rehabilitation exercises an additional three times a week at home. An exercise leaflet used in the PR classes will be given to be filled out at home.

Those randomised to receive the online programme will be loaned a computer/tablet for the six-week duration, given log-in details and a password, and instructions to begin the programme at home. A further visit to these participants home may need to be arranged to ensure that the Internet connection is suitable. If the internet connection is unsuitable, the participant will be withdrawn from the study and referred to the NHS PR. The online programme mirrors the conventional face-to-face PR programme and the exercise and educational components are given by means of instructional videos. Participants will be instructed to exercise five times a week. Participants in the online arm will receive during the PR course telephone contact to record any adverse or serious adverse events. They will be contacted twice during the first 2 weeks, then weekly for the remaining 5 weeks.

After completing the 6- week online PR or the 6- week conventional PR, participants will have their final visit arranged which will take place at the Queen Alexandra Hospital. The pre-PR measurements including the two 6-minute walking tests and quality of life questionnaires will be repeated, and results collected. These measurements will be statistically analysed for comparison between the two arms of the study to ensure the online PR is not inferior to face-to-face PR.

Eligibility criteria: Inclusion Criteria:

1. Subjects able to complete all study procedures and give written informed consent.
2. A diagnosis of COPD defined as per the NICE COPD guidelines with an MRC score of 2 or greater or appropriately symptomatic patients.
3. Male or female volunteers aged 40+ with a diagnosis of COPD referred for pulmonary rehabilitation
4. Access to the internet and ability to operate a web platform

Exclusion Criteria:

1. Patients who have had an exacerbation requiring additional antibiotics and/or an additional course of steroids within 2 weeks prior to commencing the study.
2. Patients who have already undertaken a pulmonary rehabilitation programme within the last 6 months
3. Patients who have another respiratory disease as their main complaint, such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
4. Uncontrolled hypertension
5. Unstable cardiovascular disease that would make pulmonary rehabilitation exercise unsafe or prevent programme participation
6. Patients who are unable to walk or whose ability to walk safely and independently is significantly impaired due to non-respiratory related conditions and/or cognitive impairment
7. Patients who are unable to read, or use an internet enabled device or do not have access to the internet at home
8. A timed 'Up and Go' test greater than 14 seconds

Primary outcomes:
measure: Six Minute Walk Distance
timeFrame: 6 weeks
measure: COPD Assesment Tool (CAT)
timeFrame: 6 weeks
Secondary outcomes:
measure: St Georges Respiratory Questionnaire
timeFrame: 6 weeks
measure: Hospital Anxiety and Depression scale
timeFrame: 6 weeks
measure: Modified Medical Research Council Dyspnoea scale
timeFrame: 6 weeks
measure: Safety
timeFrame: 6 weeks
measure: Adherence
timeFrame: 6 week
measure: Usability of online platform
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospital NHS Trust
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Ben Green, Dr
role: PRINCIPAL_INVESTIGATOR
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