Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881590
Status:
COMPLETED
Last Update Posted:
2023-11-03
First Post:
2023-04-17
Brief Title:
Hybrid Pulmonary Rehabilitation Study
Sponsor:
Anglia Ruskin University
Organization:
Anglia Ruskin University
Study Overview
Official Title:
Real-world Evidence Feasibility Trial in Both Community and Hospital-based Settings for a Technology-enabled Hybrid Service Delivery Model for Pulmonary Rehabilitation Assessing Patient Uptake and Adherence and Impact on Patient Outcomes and Service Capacity
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary rehabilitation is an exercise and education programme that helps improve breathlessness and quality of life for people living with lung and breathing problems It improves exercise levels and breathlessness and is a recommended treatment for people with lung diseases and symptoms Standard pulmonary rehabilitation programmes involve individuals attending group classes at hospitals or community centres twice a week for 8 weeks These classes are supervised by physiotherapists At the moment there are long waiting times for pulmonary rehabilitation in the NHS
Some patients may prefer more pulmonary rehabilitation based in their own home This might be because they find it difficult to travel to classes Some would like to do more home pulmonary rehabilitation in between supervised classes or continue pulmonary rehabilitation after the 8-week supervised programme The blending between supervised classes and home pulmonary rehabilitation is known as HYBRID PULMONARY REHABILITATION Hybrid pulmonary rehabilitation is not being provided routinely in the NHS but the NHS would like to see it used more as it might help reduce waiting times and give patients more choice on how to access pulmonary rehabilitation
The study will assess the feasibility of a larger study to provide strong evidence on patients uptake and adherence to the hybrid programme and the impact on patients health outcomes and service delivery The investigators will also look at what measures would be best to use in a larger study
The study will recruit up to 100 patients These individuals will be aged 18 years or older have respiratory disease and a referral for pulmonary rehabilitation Individuals with reasons why they cannot exercise will be excluded
Participants will be provided with an application App that can be installed on a mobile phone This App is called Activeme REMOTE and is made by a company called Aseptika Ltd wwwactiv8rlivescom Activeme REMOTE provides live online video exercise classes pre-recorded exercise classes a walking programme educational talks and a care plan personalised for the user
Data will be collected at the beginning and end of the hybrid pulmonary rehabilitation programme and will include routinely collected data as part of usual care Additional data will be collected via the App and trial surveys The investigators will ask staff and patients about the experiences of the new way of delivering rehabilitation and explore how cost effective it is
Some patients may prefer more pulmonary rehabilitation based in their own home This might be because they find it difficult to travel to classes Some would like to do more home pulmonary rehabilitation in between supervised classes or continue pulmonary rehabilitation after the 8-week supervised programme The blending between supervised classes and home pulmonary rehabilitation is known as HYBRID PULMONARY REHABILITATION Hybrid pulmonary rehabilitation is not being provided routinely in the NHS but the NHS would like to see it used more as it might help reduce waiting times and give patients more choice on how to access pulmonary rehabilitation
The study will assess the feasibility of a larger study to provide strong evidence on patients uptake and adherence to the hybrid programme and the impact on patients health outcomes and service delivery The investigators will also look at what measures would be best to use in a larger study
The study will recruit up to 100 patients These individuals will be aged 18 years or older have respiratory disease and a referral for pulmonary rehabilitation Individuals with reasons why they cannot exercise will be excluded
Participants will be provided with an application App that can be installed on a mobile phone This App is called Activeme REMOTE and is made by a company called Aseptika Ltd wwwactiv8rlivescom Activeme REMOTE provides live online video exercise classes pre-recorded exercise classes a walking programme educational talks and a care plan personalised for the user
Data will be collected at the beginning and end of the hybrid pulmonary rehabilitation programme and will include routinely collected data as part of usual care Additional data will be collected via the App and trial surveys The investigators will ask staff and patients about the experiences of the new way of delivering rehabilitation and explore how cost effective it is
Detailed Description:
Pulmonary rehabilitation PR for patients with respiratory disease eg chronic obstructive pulmonary disease COPD and bronchiectasis improves exercise capacity quality-of-life and provides vital education for condition management PR is now recommended for all COPD patients NICE guidelines NG115
A standard PR programme involves two in-person exercise classes per week over a period of 8 weeks after which the patient is discharged to self-care While retaining some in-person contact technology could increase access and automate delivery of education and exercise by overcoming shortages of skilled staff New technology exists to allow the delivery of a hybrid PR programme which may be used to support a move to a remotely delivered service with patients having the opportunity to attend in-person PR sessions during the programme if they need the motivation or support of an in-person session
This study will use the UKCACE Class I-approved and DTAC-certified Activeme REMOTE App Aseptika Ltd wwwactiv8rlivescom The Activeme App accessible by patients on their smartphones with Bluetooth or connected medical monitors includes remote tracking of adherence symptoms and physiological parameters where appropriate live online video exercise classes pre-recorded classes a paced walking programme an educational programme delivered in bite-sized pieces and personalised care plans for every patient
Generally NICE guidance draws on randomised controlled trials RCTs to inform guidelines however RCTs are costly and time consuming for digital healthcare and this delays uptake and adoption by the NHS New and innovative approaches to obtaining effectiveness evidence for digitally delivered healthcare are urgently needed and new approaches and solutions are being reviewed by NICE This feasibility study will use a real-world study design drawing on routinely collected data to compare outcomes for patients recruited to a Hybrid PR Intervention with a propensity-matched Control Group that has previously received Standard PR Additional data will be collected from the Hybrid PR group via Activeme REMOTE Trial Surveys to provide supporting evidence relating to uptake adherence clinical outcomes not routinely recorded in standard practice and usabilityacceptability of the Hybrid PR programme
Patients with chronic respiratory disease who are referred to the Harefield Pulmonary Rehabilitation Programme will be screened for eligibility to participate in the Hybrid PR Trial Informed consent will obtained in eligible patients who wish to take part Recruited participants will follow a hybrid PR programme Intervention Group The Control Group will be patients that have previously received a standard pulmonary rehabilitation programme and are matched on specified criteria including age sex measure of respiratory disability index of multiple deprivation exercise capacity and hospital vs community location
Following their informed consent the Hybrid PR Intervention Group will attend an onboarding session where a member of the clinical research team will i download the Activeme REMOTE App onto patients smartphone or provide patients without a smartphone one on which the App is preloaded and ii connect the patients Activeme REMOTE account to the clinical team via a secure clinical portal The clinician will also assign appropriate monitoring devices eg BP monitor Inhaler tracker smart weight scale pulse oximeter peak flow monitor to the participant After saving the participants details the patients App dashboard will be displayed and as required the clinician will demonstrate exercise educational content of the App
Participants will have a preliminary in-person assessment with a member of the Harefield Pulmonary Rehabilitation Team as part of routine care The participant will then follow the 8-week Hybrid PR intervention involving two exercise classes per week While this is an 8-week programme this may be extended to up to 12 weeks for some patients for example if the patient is not able to attend 2 sessions per week After completing the Hybrid PR programme the participant will have a discharge assessment as part of routine care
Demographic data from routine medical records and data on service location ie hospital vs community setting will be collected at baseline for the Hybrid PR Intervention and the Control Group Data from routine medical records will be collected both at baseline and on completing the HybridStandard PR programme These data will include measures of exercise capacity disease knowledge lower limb function health-related quality of life anxiety and depression and breathlessness Additional research data collection in the Hybrid PR Group will include
a questionnaire at baseline and on completion of the intervention to measure patient activation ie knowledge skills and confidence to manage their own healthwellbeing This will be administered by a member of the clinical research team who will add the information to the Clinical Portal
A symptoms survey built into the Activeme App which will be completed daily
Uptakeadherence to the Hybrid PR programme including number of sessions completeddropouts activity adherence educational adherence and medication adherence this will be remotely tracked via the Activeme App
The study will undertake qualitative interviewsfocus groups in staff and patient participants involved in the Hybrid PR Programme
The eligibility criteria for the interviewsfocus groups will be
i Hospital staff delivering Hybrid PR via the Activeme REMOTE platform ii Patients who have agreed to take part in the Hybrid PR intervention
For the qualitative component staff will be sent an email invite to participate in a focus group together with an information sheet and a copy of the consent form As part of their informed consent for taking part in the Hybrid PR intervention patient participants will be given the option to agree to take part in the qualitative component Not all patients who agree to the qualitative component will be invited to take part instead a purposively selected group with a broad range of characteristics eg age gender stage of disease will be selected
The qualitative research with staff will explore the experience of delivering the Hybrid PR programme whether anticipated and unanticipated barriers were overcome and perceptions of success Any potential cost savings will be explored Interviewsfocus groups with patient participants will address their experience of the Hybrid PR programme and the barriers and facilitators to using different components of the blended PR pathway
This feasibility study will generate evidence to support larger trial to compare effectiveness of a Hybrid PR vs Standard PR delivery model on patient uptake adherence and outcomes and service capacity The aim of the larger trial is to provide definitive evidence to inform clinical guidelines for PR delivery
A standard PR programme involves two in-person exercise classes per week over a period of 8 weeks after which the patient is discharged to self-care While retaining some in-person contact technology could increase access and automate delivery of education and exercise by overcoming shortages of skilled staff New technology exists to allow the delivery of a hybrid PR programme which may be used to support a move to a remotely delivered service with patients having the opportunity to attend in-person PR sessions during the programme if they need the motivation or support of an in-person session
This study will use the UKCACE Class I-approved and DTAC-certified Activeme REMOTE App Aseptika Ltd wwwactiv8rlivescom The Activeme App accessible by patients on their smartphones with Bluetooth or connected medical monitors includes remote tracking of adherence symptoms and physiological parameters where appropriate live online video exercise classes pre-recorded classes a paced walking programme an educational programme delivered in bite-sized pieces and personalised care plans for every patient
Generally NICE guidance draws on randomised controlled trials RCTs to inform guidelines however RCTs are costly and time consuming for digital healthcare and this delays uptake and adoption by the NHS New and innovative approaches to obtaining effectiveness evidence for digitally delivered healthcare are urgently needed and new approaches and solutions are being reviewed by NICE This feasibility study will use a real-world study design drawing on routinely collected data to compare outcomes for patients recruited to a Hybrid PR Intervention with a propensity-matched Control Group that has previously received Standard PR Additional data will be collected from the Hybrid PR group via Activeme REMOTE Trial Surveys to provide supporting evidence relating to uptake adherence clinical outcomes not routinely recorded in standard practice and usabilityacceptability of the Hybrid PR programme
Patients with chronic respiratory disease who are referred to the Harefield Pulmonary Rehabilitation Programme will be screened for eligibility to participate in the Hybrid PR Trial Informed consent will obtained in eligible patients who wish to take part Recruited participants will follow a hybrid PR programme Intervention Group The Control Group will be patients that have previously received a standard pulmonary rehabilitation programme and are matched on specified criteria including age sex measure of respiratory disability index of multiple deprivation exercise capacity and hospital vs community location
Following their informed consent the Hybrid PR Intervention Group will attend an onboarding session where a member of the clinical research team will i download the Activeme REMOTE App onto patients smartphone or provide patients without a smartphone one on which the App is preloaded and ii connect the patients Activeme REMOTE account to the clinical team via a secure clinical portal The clinician will also assign appropriate monitoring devices eg BP monitor Inhaler tracker smart weight scale pulse oximeter peak flow monitor to the participant After saving the participants details the patients App dashboard will be displayed and as required the clinician will demonstrate exercise educational content of the App
Participants will have a preliminary in-person assessment with a member of the Harefield Pulmonary Rehabilitation Team as part of routine care The participant will then follow the 8-week Hybrid PR intervention involving two exercise classes per week While this is an 8-week programme this may be extended to up to 12 weeks for some patients for example if the patient is not able to attend 2 sessions per week After completing the Hybrid PR programme the participant will have a discharge assessment as part of routine care
Demographic data from routine medical records and data on service location ie hospital vs community setting will be collected at baseline for the Hybrid PR Intervention and the Control Group Data from routine medical records will be collected both at baseline and on completing the HybridStandard PR programme These data will include measures of exercise capacity disease knowledge lower limb function health-related quality of life anxiety and depression and breathlessness Additional research data collection in the Hybrid PR Group will include
a questionnaire at baseline and on completion of the intervention to measure patient activation ie knowledge skills and confidence to manage their own healthwellbeing This will be administered by a member of the clinical research team who will add the information to the Clinical Portal
A symptoms survey built into the Activeme App which will be completed daily
Uptakeadherence to the Hybrid PR programme including number of sessions completeddropouts activity adherence educational adherence and medication adherence this will be remotely tracked via the Activeme App
The study will undertake qualitative interviewsfocus groups in staff and patient participants involved in the Hybrid PR Programme
The eligibility criteria for the interviewsfocus groups will be
i Hospital staff delivering Hybrid PR via the Activeme REMOTE platform ii Patients who have agreed to take part in the Hybrid PR intervention
For the qualitative component staff will be sent an email invite to participate in a focus group together with an information sheet and a copy of the consent form As part of their informed consent for taking part in the Hybrid PR intervention patient participants will be given the option to agree to take part in the qualitative component Not all patients who agree to the qualitative component will be invited to take part instead a purposively selected group with a broad range of characteristics eg age gender stage of disease will be selected
The qualitative research with staff will explore the experience of delivering the Hybrid PR programme whether anticipated and unanticipated barriers were overcome and perceptions of success Any potential cost savings will be explored Interviewsfocus groups with patient participants will address their experience of the Hybrid PR programme and the barriers and facilitators to using different components of the blended PR pathway
This feasibility study will generate evidence to support larger trial to compare effectiveness of a Hybrid PR vs Standard PR delivery model on patient uptake adherence and outcomes and service capacity The aim of the larger trial is to provide definitive evidence to inform clinical guidelines for PR delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None