Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03662438
Status:
UNKNOWN
Last Update Posted:
2019-06-24
First Post:
2018-08-29
Brief Title:
HOPE Home-based Oxygen Portable and Exercise for Patients on Long Term Oxygen Therapy LTOT
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
HOPE Home-based Oxygen Portable and Exercise - Improving Mobility in Patients on Long Term Oxygen Therapy a Home-based Physiotherapy Programme With Novel Ambulatory Oxygen Device
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
RECRUITING
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:
HOPE
Brief Summary:
Long term oxygen therapy LTOT is proven to increase the survival of patients with respiratory failure most commonly from diseases such as Chronic Obstructive Pulmonary Disease COPD At least 15 hours usage per day is needed to improve mortality Most patients on LTOT utilise bulky oxygen concentrators OC which run on continuous Alternating Current AC power This intervention however limits patient mobility and social engagement as patients are tethered to their device and confined to their homes
Reduced physical activity levels have been shown in COPD patients to be associated with reduced quality of life QoL increased admission rates to hospital and survival even after adjustment for severity of COPD Significant benefits stand to be made by improving physical activity levels in LTOT patients Pulmonary Rehabilitation PR which is traditionally conducted in a healthcare setting is an established intervention that addresses this by improving exercise tolerance but uptake and completion rates have been low due to reasons such as cost and difficulty with transport LTOT usage is also cited as an independent barrier to PR
The investigators propose the establishment of a 10-week home-based physiotherapy programme as a novel community-centric and resource-lean intervention that seeks to improve the physical activity level of LTOT patients Patients will be prescribed an ambulatory oxygen device and receive education on its usage in conjunction with a home exercise regimen which includes a home visit and subsequent telephone support by a physiotherapist in partnership with a community-based healthcare provider
A prospective pilot study of 30 patients is proposed The outcome measures include mobility function activity levels generic and disease-specific QoL
If successful our programme may revolutionize the approach to LTOT patients in Singapore and improve their ability to function independently in the community greatly in addition the reduction in hospital-based healthcare utilisation is greatly advantageous
Reduced physical activity levels have been shown in COPD patients to be associated with reduced quality of life QoL increased admission rates to hospital and survival even after adjustment for severity of COPD Significant benefits stand to be made by improving physical activity levels in LTOT patients Pulmonary Rehabilitation PR which is traditionally conducted in a healthcare setting is an established intervention that addresses this by improving exercise tolerance but uptake and completion rates have been low due to reasons such as cost and difficulty with transport LTOT usage is also cited as an independent barrier to PR
The investigators propose the establishment of a 10-week home-based physiotherapy programme as a novel community-centric and resource-lean intervention that seeks to improve the physical activity level of LTOT patients Patients will be prescribed an ambulatory oxygen device and receive education on its usage in conjunction with a home exercise regimen which includes a home visit and subsequent telephone support by a physiotherapist in partnership with a community-based healthcare provider
A prospective pilot study of 30 patients is proposed The outcome measures include mobility function activity levels generic and disease-specific QoL
If successful our programme may revolutionize the approach to LTOT patients in Singapore and improve their ability to function independently in the community greatly in addition the reduction in hospital-based healthcare utilisation is greatly advantageous
Detailed Description:
This will be an investigator-initiated prospective pilot study which aims to recruit 30 patients in total and conducted over 24 months
Study Aims and Hypotheses Utilisation of healthcare resources and burden of care on society for LTOT patients is disproportionately high The study investigators aim to describe this group of patients and introduce an intervention that aims to promote quality living with a home-based physiotherapy programme
1 To test the hypothesis that the intervention of a home-based physiotherapy programme together with a lightweight POC will improve physical activity level reduce daily time spent in sedentary activity improve Quality of Life QoL and reduce symptoms of anxiety and depression of patients on LTOT
2 To describe the functional status of patients on LTOT and their caregivers - physical activity levels body mass index psychological socio-economic background activities of daily living ADL status
3 To describe the barriers to uptake of ambulatory oxygen in patients who fulfil criteria for LTOT
4 As there is a lack of local data on the effectiveness and safety of a home-based physiotherapy program the study being conducted is a pilot study intended to establish the feasibility of a home-based physiotherapy programme
STUDY BACKGROUND
1 Long-term oxygen therapy LTOT is an established medical intervention that has been shown to prolong the survival of a select group of patients with respiratory failure 1 2 Although local data on the incidence and prevalence of LTOT use in Singapore is lacking it has been reported in the Danish Oxygen Register that the annual incidence and prevalence of LTOT use in 2010 was 322 and 481 per 100000 inhabitants respectively 3 Older studies have reported a LTOT prevalence of 28 per 100000 in 1992 in the French Oxygen Register 4 LTOT incidence and prevalence of 71 and 24 per 100000 respectively in 2000 in the Swedish Oxygen Register 5 and prevalence of LTOT of 241 per 100000 in the USA in 1994 6 Chronic Obstructive Pulmonary Disease COPD is by far the main respiratory diagnosis in LTOT patients followed by other diseases such as interstitial lung disease and bronchiectasis 7 In addition the medical literature has documented rising LTOT usage over the years due to reasons such as increasing survival of COPD patients and increased physician and patient awareness of the benefits of LTOT 8 The costs of LTOT have been recognised to be high with an estimated 800000 patients in USA utilising LTOT at cost of approximately 14 billion American dollars annually according to a 1995 publication by ODonohue et al 9 Total Medicare payments for LTOT in 1998 were reported to be USD 13 billion 10 A more recent analysis of 329482 Medicare beneficiaries with COPD who received oxygen from 2001 to 2010 found that 73659 224 received oxygen therapy 8
2 The majority of patients utilise oxygen concentrators OC 311 which typically run on continuous AC power and weigh between 13-22kg This intervention although life-prolonging nonetheless limits patient mobility as patients are required to utilise oxygen therapy for at least 15 hours a day to benefit As a result many patients become confined in their homes
3 Indeed patients with chronic respiratory disease requiring LTOT have been reported to be severely limited in their physical activity Studies of patients on LTOT have shown that 46 of patients walk less than 600m per day 12 and up to 45 are house-bound 13 While this may be due to low exercise tolerance oxygen therapy may be a contributory factor in itself as patients receiving oxygen from a stationary source often become tethered their device over time Although there are theoretical benefits to improving exercise tolerance with oxygen therapy 14 it has been reported that patients with severe COPD on LTOT have significantly reduced levels of domestic activity compared with patients with COPD of similar severity but who were not on LTOT 15 Patients with severe COPD and broadly similar health status on LTOT have also been reported to be less independent on activities of daily living than those not requiring LTOT 16
4 Apart from reduced quality of life reductions in daily activity levels have been shown to be related to clinically relevant outcomes in COPD patients such as reduced health status 17 hospital admissions 18 19 and survival 19 even after adjustment for severity of COPD Over the years interest has shifted from improving exercise capacity to increasing daily physical activity 20 which is defined as any bodily movement produced by the contraction of skeletal muscles that increased energy expenditure 21 In fact it was found in a prospective cohort study of 170 outpatients with stable COPD that objectively measured physical activity was the strongest predictor for all-cause mortality in patients with COPD and that there was a linear association between physical activity and mortality 22 Significant gains in quality of life and reduced utilisation of healthcare stand to be made if the physical activity and mobility profile of patients on LTOT can be increased
5 An established intervention to improve the mobility and physical activity levels of LTOT patients is Pulmonary Rehabilitation PR PR is a structured multidimensional and multidisciplinary programme over time at least 6 weeks that comprises physical training and breathing exercises supervised by a respiratory physiotherapist in conjunction with education guided by objective tests of the respiratory system and exercise capacity such as pulmonary function tests 6-minute walk test and cardiopulmonary exercise testing PR been shown to be cost-effective and beneficial in improving shortness of breath health status and exercise tolerance in patients of all grades of COPD severity including patients with chronic respiratory failure on LTOT 23
6 Although the benefits of PR are established uptake and completion of PR is frequently limited The percentage of referred participants who did not attend PR at all ranged from 83 to 496 in a systematic review 24 Many barriers have been cited such as low referral rates from healthcare providers 25 and low patient and healthcare provider awareness of its availability and benefits Usage of LTOT has also been found to an independent predictor for non-attendance to PR 26 This is not surprising as patients on LTOT face even greater difficulty than the average patient in participating in PR due to challenges in being able to independently navigate the transportation system to attend outpatient PR whilst on oxygen therapy Another major barrier worth mentioning is the lack of access from a combination of factors of geography culture finances transportation and other logistics 27 28 This may be due to the fact that PR is a healthcare-provider centric intervention that is traditionally conducted in a healthcare institution in an outpatient or inpatient setting
7 Locally in Singapore patients face a financial disincentive towards participating in PR in the outpatient setting as Medisave the national medical savings scheme imposes limits on withdrawals for outpatient healthcare expenditure Outpatient PR also imposes hidden costs to the patient in the form of transportation and missed days at work for family caregivers who accompany the patient for outpatient PR Patients are often accompanied by family caregivers or sponsors to healthcare visits in Singapore and the lack of a caregiver to accompany patients for outpatient PR is an important cultural barrier to PR Inpatient PR in Singapore on the other hand is also limited in its capacity to serve many patients due to the national strain on hospital beds PR clearly has its limitations as a modality in improving the poor physical activity levels of patients on LTOT and a novel solution is needed that addresses the many barriers with PR uptake
8 The investigators are therefore proposing the establishment of a home-based physiotherapy programme as a novel community and patient-centric and resource-lean intervention that seeks to improve the physical activity of LTOT patients Patients will be prescribed an ambulatory oxygen device and receive education on its usage in conjunction with a home exercise regimen which would include a home visit by a physiotherapist It is hypothesised that home-based physiotherapy would be more patient-centric compared to healthcare centre-based physiotherapy as realistic rehabilitation goal settings and exercise regimens can be personalised to each patients unique home and community environment lifestyle and care needs The proposed intervention would be similar to an 8-week home-based PR study recently conducted in the UK which comprised 1 home visit and 7 once-weekly telephone calls from a physiotherapist in the home-based intervention arm which found equivalent short-term outcomes such as exercise tolerance and dyspnoea-related quality of life that were equivalent to outpatient centre-based PR 29
9 Ambulatory Oxygen AO is an important enabler in improving the mobility of patients on LTOT in the community and therefore their participation in PR However there remain many barriers to the uptake of AO such as i lack of instruction on the usage of AO and particularly with regards to AO delivered via oxygen cylinders ii fear of running out of their AO supply while they were using it iii embarrassment and iv difficulties with carrying the AO supply 30
10 These barriers have led to low usage rates of AO via oxygen cylinder with only 39 of patients using AO for more than 2 hours a week in a Danish study published in 1999 31 In the same study it was reported that when patients had outdoor activity the usage of stationary oxygen fell by a couple of hours resulting in lower overall oxygen usage This suggested that patients were spending a considerable time outside their home without using their AO 31 In Italy where LTOT is almost exclusively provided by liquid oxygen it was reported that although most patients 84 possessed an AO device only 40 declared that they used it daily with being ashamed of being seen by passersby with a stroller being the principal barrier 7 Similar data was presented in a French study which reported that most patients 630930 used their oxygen only while resting 32
11 Compared to oxygen cylinders AO delivered by lightweight Portable Oxygen Concentrator POC has the advantages of being i user-friendly ii aesthetically more pleasing and is iii easily rechargeable with standard household electrical supply 33
Such advantages will overcome some of the aforementioned barriers to AO usage
12 A prospective pilot study of 30 patients is proposed Assessment of activity levels QoL and breathlessness will be measured before and after 10 weeks The 2 components of the proposed intervention namely the home-based physiotherapy programme and the prescription of a lightweight POC are synergistic in its effects Supplemental oxygen has been shown to improve exercise duration 34 and therefore rehabilitation while it has been shown that effective use of oxygen was improved by follow-up education whether given by nurse or physiotherapist after initiation of oxygen therapy 32 It has been shown that the prescription of AO alone does not automatically assure good adherence to the prescribed treatment or use of AO outdoors 30 The guidance from the home-based physiotherapy programme will comprise of a home visit by a physiotherapist with the aim of reinforcing compliance and usage of AO outside the house thereby improving the patients mobility over simply prescribing an AO device It is hypothesised therefore that patients will be encouraged to use their AO device when they are guided by a home-based physiotherapy programme where rehabilitation goals and exercises are tailored to each patients unique life-space in the home and community
13 In summary the proposed intervention of a home-based activity education programme in partnership with a community healthcare provider and in conjunction with a lightweight POC may revolutionize the approach to patients with chronic respiratory failure in Singapore and improve their ability to function independently in the community greatly in addition the ability to stay active and community ambulant as well as the reduction the demand on national healthcare resources eg inpatient rehabilitation beds for PR is greatly advantageous
Note - References have been cited in subsequent sections
Study Aims and Hypotheses Utilisation of healthcare resources and burden of care on society for LTOT patients is disproportionately high The study investigators aim to describe this group of patients and introduce an intervention that aims to promote quality living with a home-based physiotherapy programme
1 To test the hypothesis that the intervention of a home-based physiotherapy programme together with a lightweight POC will improve physical activity level reduce daily time spent in sedentary activity improve Quality of Life QoL and reduce symptoms of anxiety and depression of patients on LTOT
2 To describe the functional status of patients on LTOT and their caregivers - physical activity levels body mass index psychological socio-economic background activities of daily living ADL status
3 To describe the barriers to uptake of ambulatory oxygen in patients who fulfil criteria for LTOT
4 As there is a lack of local data on the effectiveness and safety of a home-based physiotherapy program the study being conducted is a pilot study intended to establish the feasibility of a home-based physiotherapy programme
STUDY BACKGROUND
1 Long-term oxygen therapy LTOT is an established medical intervention that has been shown to prolong the survival of a select group of patients with respiratory failure 1 2 Although local data on the incidence and prevalence of LTOT use in Singapore is lacking it has been reported in the Danish Oxygen Register that the annual incidence and prevalence of LTOT use in 2010 was 322 and 481 per 100000 inhabitants respectively 3 Older studies have reported a LTOT prevalence of 28 per 100000 in 1992 in the French Oxygen Register 4 LTOT incidence and prevalence of 71 and 24 per 100000 respectively in 2000 in the Swedish Oxygen Register 5 and prevalence of LTOT of 241 per 100000 in the USA in 1994 6 Chronic Obstructive Pulmonary Disease COPD is by far the main respiratory diagnosis in LTOT patients followed by other diseases such as interstitial lung disease and bronchiectasis 7 In addition the medical literature has documented rising LTOT usage over the years due to reasons such as increasing survival of COPD patients and increased physician and patient awareness of the benefits of LTOT 8 The costs of LTOT have been recognised to be high with an estimated 800000 patients in USA utilising LTOT at cost of approximately 14 billion American dollars annually according to a 1995 publication by ODonohue et al 9 Total Medicare payments for LTOT in 1998 were reported to be USD 13 billion 10 A more recent analysis of 329482 Medicare beneficiaries with COPD who received oxygen from 2001 to 2010 found that 73659 224 received oxygen therapy 8
2 The majority of patients utilise oxygen concentrators OC 311 which typically run on continuous AC power and weigh between 13-22kg This intervention although life-prolonging nonetheless limits patient mobility as patients are required to utilise oxygen therapy for at least 15 hours a day to benefit As a result many patients become confined in their homes
3 Indeed patients with chronic respiratory disease requiring LTOT have been reported to be severely limited in their physical activity Studies of patients on LTOT have shown that 46 of patients walk less than 600m per day 12 and up to 45 are house-bound 13 While this may be due to low exercise tolerance oxygen therapy may be a contributory factor in itself as patients receiving oxygen from a stationary source often become tethered their device over time Although there are theoretical benefits to improving exercise tolerance with oxygen therapy 14 it has been reported that patients with severe COPD on LTOT have significantly reduced levels of domestic activity compared with patients with COPD of similar severity but who were not on LTOT 15 Patients with severe COPD and broadly similar health status on LTOT have also been reported to be less independent on activities of daily living than those not requiring LTOT 16
4 Apart from reduced quality of life reductions in daily activity levels have been shown to be related to clinically relevant outcomes in COPD patients such as reduced health status 17 hospital admissions 18 19 and survival 19 even after adjustment for severity of COPD Over the years interest has shifted from improving exercise capacity to increasing daily physical activity 20 which is defined as any bodily movement produced by the contraction of skeletal muscles that increased energy expenditure 21 In fact it was found in a prospective cohort study of 170 outpatients with stable COPD that objectively measured physical activity was the strongest predictor for all-cause mortality in patients with COPD and that there was a linear association between physical activity and mortality 22 Significant gains in quality of life and reduced utilisation of healthcare stand to be made if the physical activity and mobility profile of patients on LTOT can be increased
5 An established intervention to improve the mobility and physical activity levels of LTOT patients is Pulmonary Rehabilitation PR PR is a structured multidimensional and multidisciplinary programme over time at least 6 weeks that comprises physical training and breathing exercises supervised by a respiratory physiotherapist in conjunction with education guided by objective tests of the respiratory system and exercise capacity such as pulmonary function tests 6-minute walk test and cardiopulmonary exercise testing PR been shown to be cost-effective and beneficial in improving shortness of breath health status and exercise tolerance in patients of all grades of COPD severity including patients with chronic respiratory failure on LTOT 23
6 Although the benefits of PR are established uptake and completion of PR is frequently limited The percentage of referred participants who did not attend PR at all ranged from 83 to 496 in a systematic review 24 Many barriers have been cited such as low referral rates from healthcare providers 25 and low patient and healthcare provider awareness of its availability and benefits Usage of LTOT has also been found to an independent predictor for non-attendance to PR 26 This is not surprising as patients on LTOT face even greater difficulty than the average patient in participating in PR due to challenges in being able to independently navigate the transportation system to attend outpatient PR whilst on oxygen therapy Another major barrier worth mentioning is the lack of access from a combination of factors of geography culture finances transportation and other logistics 27 28 This may be due to the fact that PR is a healthcare-provider centric intervention that is traditionally conducted in a healthcare institution in an outpatient or inpatient setting
7 Locally in Singapore patients face a financial disincentive towards participating in PR in the outpatient setting as Medisave the national medical savings scheme imposes limits on withdrawals for outpatient healthcare expenditure Outpatient PR also imposes hidden costs to the patient in the form of transportation and missed days at work for family caregivers who accompany the patient for outpatient PR Patients are often accompanied by family caregivers or sponsors to healthcare visits in Singapore and the lack of a caregiver to accompany patients for outpatient PR is an important cultural barrier to PR Inpatient PR in Singapore on the other hand is also limited in its capacity to serve many patients due to the national strain on hospital beds PR clearly has its limitations as a modality in improving the poor physical activity levels of patients on LTOT and a novel solution is needed that addresses the many barriers with PR uptake
8 The investigators are therefore proposing the establishment of a home-based physiotherapy programme as a novel community and patient-centric and resource-lean intervention that seeks to improve the physical activity of LTOT patients Patients will be prescribed an ambulatory oxygen device and receive education on its usage in conjunction with a home exercise regimen which would include a home visit by a physiotherapist It is hypothesised that home-based physiotherapy would be more patient-centric compared to healthcare centre-based physiotherapy as realistic rehabilitation goal settings and exercise regimens can be personalised to each patients unique home and community environment lifestyle and care needs The proposed intervention would be similar to an 8-week home-based PR study recently conducted in the UK which comprised 1 home visit and 7 once-weekly telephone calls from a physiotherapist in the home-based intervention arm which found equivalent short-term outcomes such as exercise tolerance and dyspnoea-related quality of life that were equivalent to outpatient centre-based PR 29
9 Ambulatory Oxygen AO is an important enabler in improving the mobility of patients on LTOT in the community and therefore their participation in PR However there remain many barriers to the uptake of AO such as i lack of instruction on the usage of AO and particularly with regards to AO delivered via oxygen cylinders ii fear of running out of their AO supply while they were using it iii embarrassment and iv difficulties with carrying the AO supply 30
10 These barriers have led to low usage rates of AO via oxygen cylinder with only 39 of patients using AO for more than 2 hours a week in a Danish study published in 1999 31 In the same study it was reported that when patients had outdoor activity the usage of stationary oxygen fell by a couple of hours resulting in lower overall oxygen usage This suggested that patients were spending a considerable time outside their home without using their AO 31 In Italy where LTOT is almost exclusively provided by liquid oxygen it was reported that although most patients 84 possessed an AO device only 40 declared that they used it daily with being ashamed of being seen by passersby with a stroller being the principal barrier 7 Similar data was presented in a French study which reported that most patients 630930 used their oxygen only while resting 32
11 Compared to oxygen cylinders AO delivered by lightweight Portable Oxygen Concentrator POC has the advantages of being i user-friendly ii aesthetically more pleasing and is iii easily rechargeable with standard household electrical supply 33
Such advantages will overcome some of the aforementioned barriers to AO usage
12 A prospective pilot study of 30 patients is proposed Assessment of activity levels QoL and breathlessness will be measured before and after 10 weeks The 2 components of the proposed intervention namely the home-based physiotherapy programme and the prescription of a lightweight POC are synergistic in its effects Supplemental oxygen has been shown to improve exercise duration 34 and therefore rehabilitation while it has been shown that effective use of oxygen was improved by follow-up education whether given by nurse or physiotherapist after initiation of oxygen therapy 32 It has been shown that the prescription of AO alone does not automatically assure good adherence to the prescribed treatment or use of AO outdoors 30 The guidance from the home-based physiotherapy programme will comprise of a home visit by a physiotherapist with the aim of reinforcing compliance and usage of AO outside the house thereby improving the patients mobility over simply prescribing an AO device It is hypothesised therefore that patients will be encouraged to use their AO device when they are guided by a home-based physiotherapy programme where rehabilitation goals and exercises are tailored to each patients unique life-space in the home and community
13 In summary the proposed intervention of a home-based activity education programme in partnership with a community healthcare provider and in conjunction with a lightweight POC may revolutionize the approach to patients with chronic respiratory failure in Singapore and improve their ability to function independently in the community greatly in addition the ability to stay active and community ambulant as well as the reduction the demand on national healthcare resources eg inpatient rehabilitation beds for PR is greatly advantageous
Note - References have been cited in subsequent sections
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SHFHSRHO0132017 | OTHER_GRANT | Singhealth Foundation | None |