Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03569384 |
| Other study ID # |
1-TELE KOL 1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2017 |
| Est. completion date |
March 31, 2020 |
Study information
| Verified date |
June 2018 |
| Source |
University of Aarhus |
| Contact |
Jose Cerdan, PhD student |
| Phone |
+4530648283 |
| Email |
ppmanucerdan[@]yahoo.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction In order to guarantee chronic patients and elderly a high quality service from
health care organizations in the coming decades, new technologies have been implemented to
treat patients from a distance. There is still a need for more studies on the efficacy and
cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be
determined. To guarantee individuals with chronic obstructive pulmonary diseases (COPD) a
high quality service from health care organizations in the coming decades and economically
save the national health systems for an expensive bill for the treatment of COPD, new actions
plans has to be taken into use. Hereby, more patients can be treated with less human
resources while still sustaining or even improving today's services. The importance of such
welfare action plans has to maintain a high quality of service that individuals with COPD are
willing to accept. Here, TR seems to be a good welfare action plans. Despite proof of
improved cost-effectiveness, no studies support the benefits of TR in COPD patient with
respect to adherence, security, treatment efficacy and improved quality of life.
Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a
new and innovative TR platform (NITRP) compared to standard treatment with respect to
exercise capacity, quality of life and activities of daily living in patients with COPD.
Method and material The study is a prospective randomized controlled trial comparing the
effects of tele-rehabilitation and conventional rehabilitation in patients with severe COPD.
54 patients fulfilling the inclusion criteria will be randomized in two groups to either a 8
week tele-rehabilitation program or a conventional COPD rehabilitation program at the
hospital. Participants will be tested at baseline, 8 weeks, 3 and 6 months after cessation of
the training programs. In the intervention group, a real- and a virtual physiotherapist agent
will facilitate the rehabilitation.
Ethical considerations This study will not pose any risk to the patient as compared to
current practice. Participation is voluntary and the patient may at any time withdraw from
the study without consequences for future care or treatment. The questionnaires and the test
methods used are clinically recognized instruments. Signed informed consent will be obtained
from the all participants after verbal and written information and before the study starts.
The study will not be initiated before approval from the Ethics Committee and the Data
Protection Agency has been obtained. The study will follow the general research ethical rules
as expressed in the Helsinki Declaration II.
Description:
Introduction
To guarantee chronic patients and elderly a high quality service from health care
organizations in the coming decades, new technologies has been implemented to treat patients
from a distance. This document reflects the latest research studies based on
tele-rehabilitation (TR), its application in chronic lung diseases and the topics that still
needs to be investigated.
Tele-rehabilitation Studies of TR in patients with lymphedema (Galiano-Castillo et al., 2014)
or COPD (Paneroni et al., 2014)(Tousignant et al., 2012)(Dinesen, Seeman, and Gustafsson,
2011)(Dinesen, Huniche, and Toft, 2013) or in the orthopedic areas as, lower back
(Palacín-Marín, Esteban-Moreno, Olea, Herrera-Viedma, & Arroyo-Morales, 2013), knee (Cabana
et al., 2010) (Tousignant, Moffet, et al., 2011) (Tousignant, Boissy, et al., 2011) and
shoulder (Eriksson, Lindström, Gard, & Lysholm, 2009)(Eriksson, Lindström, & Ekenberg, 2011)
show that tele-technology has been developed to a level where it is possible to treat, test
and follow-up patients from a distance. Patients who have not been offered such solutions
face increased risks of hospital-acquired infections (Dancer, 2009) and longer travel and
waiting time to get treated. The public sector expects higher expenditure due to treatment
and transportation cost, specifically in chronic patients and the elderly whose numbers tends
to increase according to demographics trend (Palacín-Marín et al., 2013)(Barros, Francisco,
Zanchetta, & César, 2011)(Parker & Thorslund, 2007)(Yach, Hawkes, Gould, and Hofman, 2004).
Such facts points to the need of creating and improving solutions that overcome such health
care challenges.
TR seems to be a good approach to reach patients in low inhabited areas (Hill and Sppath,
2010), changing health care to self-care (Haarder, 2011), empowering patient's awareness of
their disease and increasing the flexibility patients need to acquire to obtain healthier
behaviors. Although the interest in TR research is high, there is still a need for more
studies on the efficacy (Paneroni et al., 2014) and cost-effectiveness of TR (Paneroni et
al., 2014) (Langberg, Lindahl, Kidholm, and Dinesen, 2014) just as the long-term effects of
TR have to be determined (Langberg et al., 2014).
Chronic obstructive pulmonary disease (COPD) COPD is among the most resource costly diseases
we face in our century (Kjøller, Juel, and Kamper-Jørgensen, 2007). In Denmark, approximately
430,000 people have COPD of which around 50,000 have severe COPD (Kirkegaard N, Brandt A,
Timm H, 2013)(Mannino, Doherty, and Sonia Buist, 2006). Eriksen (Eriksen and Vestbo, 2010)
states that up to 42.3% of patients with COPD discharged from hospitals are readmitted the
following year, and 17% of patients treated in emergency departments require hospitalization.
Danish pulmonary physicians concluded that COPD cost the Danish society three billion DKK in
2002 (Hos, 2007) where up to 20% of the most severe COPD patients consume over 70% of the
total health expenditure (Jansson et al., 2002). Nowadays, some municipalities have already
problems with offering rehabilitation services to all COPD patients in some areas in Denmark
(Kjøller et al., 2007). Actions implementing TR for COPD patients have been started and
research begins to show some improvements.
Pulmonary rehabilitation in COPD The objective of treatment for patients with COPD is to
delay the progression of the disease, prevent acute exacerbations, improve quality of life,
reduce symptoms and reduce mortality. Rehabilitation of COPD includes among others physical
training and patient education (Sundhedsstyrelsen, 2007). There is a need for an improved
prevention and treatment of exacerbations (Barnes, Calverley, Kaplan, & Rabe, 2013). Despite
the poor evidence about determinants of physical activity and impact of treatment in COPD
patients (Gimeno-Santos et al., 2014), a wide range of interventions are commonly used by
physiotherapist to treat individuals with COPD (Kozu et al., 2011),(Kenn, Gloeckl, and Behr,
2013) (Garrod and Lasserson, 2007). Researchers have shown significant improvement in general
condition (Lacasse, Guyatt, and Goldstein, 1997)(Ries, Kaplan, Limberg, and Prewitt,
1995)(Lacasse, Goldstein, Tj, and Martin, 2009)(Nava, 1998)(Simpson, Killian, McCartney,
Stubbing, and Jones, 1992), quality of life (Wijkstra et al., 1995)(Bendstrup 1997),
long-term survival (Godoy 2007), sputum clearance (Garrod 2007) (Oldenburg 1979);
Health-related quality of life (Almagro 2013) (Blackstock 2013) (Jones, 2013)(Bendstrup et
al. 1997), training of muscle strength and exercise tolerance (Ortega et al., 2002)(Bendstrup
et al., 1997), walking distance (Ries et al. 2007) (Ringbaek 2008) (Wedzicha et al., 1998),
exercise capacity, endurance (Lacasse et al., 1997) (Ries et al., 1995) (Lacasse et al.,
2009) (Nava 1998) (Simpson et al., 1992); days of hospitalization (Ries et al., 2007)
(Griffiths et al., 2000), tachypnea (Lacasse et al., 1997) (Ortega et al., 2002) and
morbidity (Godoy, 2007). Although the advantages of PR are many, its implementation should be
placed alongside the routine treatment options (Ozalevli 2010). It has been shown that the
frequency of emergency department presentations and hospital admissions in COPD patients was
significantly reduced after participation in early discharge care with ongoing follow-up
support (Lawlor et al., 2009).
Tele-rehabilitation in COPD Tele-rehabilitation at home is feasible and well accepted by
patients, although technology may be perceived as difficult (Paneroni et al.,
2014)(Tousignant et al., 2012). It seems to improve walking capacity, dyspnea, quality of
life and daily physical activity (Paneroni et al., 2014). The interaction between the COPD
patients at home and the healthcare professionals at the clinic through TR has evolved as a
dialogue channel forming the basis for mutual learning processes and new relationships
(Dinesen 2011). Here, patients exhibit four types of attitudes about their
tele-rehabilitation: indifference, learning as part of situations in everyday life, feeling
of security and motivation for performing physical training (Dinesen et al., 2013).
Preliminary evaluations from tele-rehabilitation initiatives in Scotland showed
tele-rehabilitation to be more cost effective for patients living in remote areas compared to
an out-reach- or centralized model (Hill 2010).
Conclusion There is still a need for more studies of the efficacy and cost-effectiveness of
TR, just as also the long-term effects of TR have to be determined. To guarantee individuals
with COPD a qualitative service from health care organizations in the coming decades and
economically save the national health systems for an expensive bill to treating COPD, new
actions plans has to be taken in mind in order to treat more patients with less human
resources and still sustaining or improving today's services. The importance of such welfare
action plans has to maintain a quality of service that individuals with COPD are willing to
accept. Here, TR seems to be a good welfare action plans. Despite improved cost
effectiveness, evidence supporting patient ´s adherence and security, treatment efficacy and
improvements of quality of life with tele-rehabilitation in COPD is still warranted.
Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a
new and innovative TR platform (NITRP) compared to standard COPD rehabilitation with respect
to exercise capacity, quality of life and activities of daily living in patients with COPD.
The primary purpose of the study is to assess the effect of tele-rehabilitation with a NITRP
compared to standard COPD rehabilitation on exercise capacity and quality of life in COPD
patients based on the following hypotheses:
Activities of daily living, exercise capacity and health-related quality of life are equal or
improved by tele-rehabilitation compared to conventional COPD rehabilitation.
The secondary purpose is to investigate the efficacy and cost effectiveness of
tele-rehabilitation with a NITRP compared to standard COPD rehabilitation on "number of acute
exacerbations and number of visits to the health care system in a period of time" and
"rehabilitation- and transportation costs" in rehabilitation of COPD patients based on the
following hypothesis:
The rehabilitation costs of tele-rehabilitation are lower or equal compared to conventional
rehabilitation.
METHOD AND MATERIAL
Design:
The study is a prospective randomized controlled trial comparing the effects of
tele-rehabilitation and conventional rehabilitation in patients with COPD.
Patients 54 adult patients with moderate to severe COPD referred for conventional COPD
rehabilitation in the outpatient clinic at the Department of Respiratory Medicine and
Allergy, Aarhus University Hospital
Inclusion criteria
In order to be eligible to participate in this study, the patient must meet all of the
following criteria:
A diagnosis of COPD (FEV1/FVC < 70% in a stable phase of the disease) Age > 18 years Referred
for conventional COPD rehabilitation Compliant patient willing to fulfill the study
requirements Signed informed consent Oxygen therapy is not an obstacle for participation.
Exclusion criteria
A potential patient who meets any of the following criteria will be excluded from
participation in this study if:
Musculoskeletal disorders limiting training Dizziness, significant sensory or motor
disabilities, dementia or terminal malignant disease precluding training Severe comorbidities
such as i.e. unstable heart disease, dysregulated diabetes, known malignant disease, any
other illness making the patient inappropriate for participating in the study Non-compliant
patient Severe vision or hearing impairment Non-Danish speaking Unwillingness or inability to
follow the protocol COPD exacerbation in the preceding 6 weeks
Sample size calculation In this non-inferiority study of tele-rehabilitation vs. standard
rehabilitation, we will use 6MWT as the primary outcome. Power calculations based on previous
rehabilitation studies in COPD results I 54 patients that should participate in this study.
The biggest allowed difference in 6MWT: +/- 35 m (Puhan et al 2008) to accept the H0: same
mean difference, assuming equal group sizes, means that 18 patients is needed in each group.
A drop-out rate less than or equal to 30% is expected (Sohanpal et al 2012). The maximum
dropout rate in the present study is set to 40%. Thus, the final power calculations results
in 54 patients, significance rate 0.05. Therefore, 27 patients will enrolled in each group.
Recruitment All COPD patients referred for rehabilitation at the Department of Respiratory
Medicine and Allergy, Aarhus University Hospital that might be eligible will be informed
about the study by their respiratory physician or physiotherapist when evaluated after
referral for rehabilitation. The patients will be asked if they are interested in
participating in this study, and if so, they will receive verbal and written information. An
enrolment letter will also be hung up at the outpatient clinic to inform potential
participants about the project. An advertisement will be published in local newspapers, on
AUH facebook and on www.forsoegsperson.dk (Appendix 4). In this information the study is
explained in detail. Potential participants are entitled to at least one day consideration
time before they decide whether to participate in the trial. They have the right to be
accompanied by a family member, friend or acquaintance for the oral information they will
receive previous to the enrolment. . The patients have to give their informed signed consent
to the principal investigator or his designee before the patient can enter the trial.
Clinical stability will be assessed by the physician. If patients are eligible they will be
randomized to the intervention group or control group.
Treatment of subjects There will be no changes in the patients' regular treatment due to
participation in the tele-rehabilitation study.
Investigational treatment The intervention is the use of a tele-rehabilitation program during
8 weeks. The patient's training time will be registered automatically. The control group will
receive standard COPD rehabilitation.
Escape medication In case of a COPD exacerbation or any other medical incidence, the patient
will be treated to the discretion of the clinician in charge and excluded from the study.
However, the patients will be offered to be included again at the moment clinical stability
is reached and the patient again fulfils inclusion criteria.
Randomisation, blinding & treatment allocation Randomisation will allocate patients to either
the intervention or control group and will be performed electronically.
Study procedures The trial is registered in the public database of Clinical Trials.gov. After
informed consent, the patients will be screened at baseline and physical examination,
pulmonary function tests and 6MWT will be performed.
Information on comorbidities and smoking status will be registered. All patients will be
asked to fill in the questionnaires on health-related quality of life, general-well-being and
anxiety. Patients will be asked to wear a pedometer and record steps during 7 days and will
be instructed not to change their daily routine while wearing this device. After returning
back the pedometer, patients allocated to the intervention group will receive instructions
about the tele-rehabilitation program while patients allocated to the control group will
start the standard rehabilitation program.
In week 8, the intervention group will again receive a pedometer to register steps for 7 days
during the intervention. 8 weeks after the end of the intervention program, pulmonary
function tests, 6MWT and the questionnaires will be repeated. The same investigations and
questionnaires are performed at follow-up after 3 and 6 months after the end of the
rehabilitation program.
Patients allocated to the control group will follow the same procedure during the first 9
weeks, except not using tele-rehabilitation.
Control group COPD patients in the control group will undergo the conventional standardized
rehabilitation program as implemented at the Department of Respiratory Medicine and Allergy,
Aarhus University Hospital. The program is an 8 weeks program consisting of 2 weekly group
training sessions at the hospital with instruction by a physiotherapists and 6 hours of
education about COPD and its treatment.
Intervention group The intervention group will follow this procedure Video Consultation (VC)
Sessions: Each patient will have the opportunity to have minimum one VC per week the first
month, one VC each second week the second month one VC a month the rest of the trial. Here
the physiotherapist, via history will extract the information needed to calibrate the daily
tele rehabilitation program according to patient's physical status and needs.
Retraining breath: Patients will also be instructed to use different techniques to breath
during the video consultations with the physiotherapist. The patient receives advice on how
to the use breathing retraining techniques such as pursed lip breathing. Because COPD
patients suffer from obstructed airways, the goal for them using PLB will be to increase
their positive expiratory pressure.
Chat Sessions: Each patient has the opportunity to chat with the physiotherapist any time via
the chat module of the system. The patient and physiotherapist will be reminded via mail,
anytime someone is writing in the chat, allowing the users to interact when needed.
Workout Sessions with a Virtual Physiotherapist Agent (VPA): The patient will train according
to what is decided by the physiotherapist and the patient in the VC or chat meetings.
Normally, the patients will train 10-20 minutes daily at home with its individual and
tailored VPA. Instead of ergometer bike training, the patient will receive some easy training
tools such as elastics and weights that can be used in the different exercises showed by the
VPA to reach the same intensity of work out. The VPA will then be animated to motivate and
encourage the patient to exercises at home. A digital diary will automatically register the
data obtained by the system on patient's performance.
Patients' security: In order to minimize the risks of possible accidents while performing the
exercises, the patient will answer questions before and after each exercise performance that
the physiotherapist can follow in real time via scales and use to calibrate the performance
of the virtual physiotherapist. The patient has the opportunity to chat with the
physiotherapist 24 hours per day any time if needed and for consultation reasons.
Study parameters/endpoints
Primary endpoint:
Change in the 6MWT measured at week 9.
Secondary endpoint:
Change in the 6MWT measured 3 and 6 months after cessation of the tele-rehabilitation program
compared to baseline.
Change in total score in health-related quality of life measured by SGRQ at week 9, and 3 and
6 months after cessation of the tele-rehabilitation program compared to baseline.
Change in total score in health-related quality of life measured by GAD-7 at week 9, and 3
and 6 months after cessation of the tele-rehabilitation program compared to baseline.
Change in component scores (symptoms, activity & impact) in health-related quality of life
measured by SGRQ at week 9, and 3 and 6 months after cessation of the tele-rehabilitation
program compared to baseline.
Cost of the tele-rehabilitation program
End point measures
Pulmonary function tests (PFT):
PFT are done as part of the routine follow-up and performed to prove disease stability. The
following pulmonary function indices will be registered:
Forced expiratory volume in 1 second (FEV1) Forced vital capacity (FVC)
6 minute walk test A 6 minute walk test will be performed at baseline, after 8 weeks, and
after 3 and 6 months after cessation of the program to assess exercise performance. The
purpose of this test is to see how far and fast the test person can walk during 6 minutes.
This test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The
distance covered over a time of 6 minutes is used as the outcome by which to compare changes
in performance capacity. During this test the patient will be asked to walk between two cones
placed 30 meters apart. The patient is asked to go to the speed he thinks he can walk without
stopping during 6 minutes. Oximetry, pulse and Borgs Dyspnea Score are tracked before, after
6, 7, and 8 minutes. Total distance is recorded after 6 minutes. The patient stops walking
after 6 minutes but recovery is also recorded at 7 and 8 minutes.
Pedometer:
To assess the physical activity status of the patient, measurement of the number of steps
walked is an indication of the magnitude of physical activity. In controlled laboratory
settings, the Yamax Digi-walker SW-200 has consistently been shown to be among the most
accurate. It's a small device worn on the belt or waist and responds to vertical
accelerations of the hip during gait cycles.
Questionnaires:
At baseline, and after 8 weeks, 3 and 6 months, the patient will be asked to self-administer
the following questionnaires on quality of life and general well-being:
IADL Instrumental Activity of Daily Living consists of seven questions related to shopping,
housework, cooking, walks, money management, handling of medications and use of telephone.
Both patients and their closest relatives (mostly spouses) should reply. For each of the
seven questions, a score of zero indicates no need for help, one indicates some needs and two
indicates inability to perform an activity without assistance. A total score is calculated on
a scale from 0 to 14. Higher scores indicate greater dependence. The form has been translated
into Danish (Appendix 1), SGRQ Sct. Georges Respiratory Questionnaire is a disease specific,
self-administered questionnaire with 50 items comprising two domains with 3 components as
symptoms, activity and impacts. Each is scored from 0-100, with higher scores corresponding
to worse health related quality of life. SGRQ has been developed for COPD patients and found
to be a valid measure of health related quality of life (Appendix 2).
GAD-7:
The General Anxiety Disorder Score measures the presence and severity of general anxiety
disorder. It is a 7 self-rated items. Each item scores 0-3. The total score range is 0-21.
Reliability and validity are excellent (Appendix 3).
COPD exacerbations The number of exacerbations and visits to the general practitioner,
emergency room or hospital during rehabilitation and follow-up will be registered, first via
a diary and corroborated then by short interviews performed during follow-up at 8 weeks and 3
and 6 months after cessation of training.
Cost The average cost of the hospital rehabilitation program and transportation per patients
for an eight weeks standard and tele-rehabilitation program and transportation will be
calculated.
Data Collection Information about patient demographics, lung function (spirometry with
measurement of FEV1 and FVC), oxygen saturation, comorbidities, smoking habits, BMI, blood
pressure, visits to the clinic, number of exacerbations, use of any public health care
service and cost of it will be registered at each visit.
Data analysis There will be used Wilcoxon rank sum test for assessing, the primary endpoint
comparing the performance of the physical functions tests between the intervention group and
control group from base line to 8 weeks, 3 and 6 months after and for the test variables with
correction for multiple comparisons. A p-value less than 0.05 will be considered
statistically significant. All patients will be analyzed in the groups they originally were
randomized from according to the intention-to-treat principles.
Differences in activities of daily living and health-related quality of life between the two
groups from baseline to 8 weeks, 3 and 6 months after will be compared with Chi2 test or
Fischer's exact test for categorical data. Continuous data will be compared with t -tests or
Wilcoxon rank sum test depending on distribution. A p-value less than 0.05 will be considered
statistically significant.
Copyrights, distribution and implications Authorship must meet the Vancouver rules, and
everyone who has contributed under this framework will be named in the author list. The
authors will try to publish the results of the study in international peer-reviewed journals
and present them at relevant conferences. Moreover, the results will be published in other
relevant media. All positive, negative and inconclusive results will be published
Ethical issues Since rehabilitation is a standard treatment offer, it is not expected that
this study will result in any risk to patients. Participation is voluntary and the patient
may, at any time, withdraw from the study without consequences for future care or treatment.
Questionnaires and test methods used are clinically recognized instruments. An informed
written consent will be obtained from the participants after verbal and written information.
The Regional Research Ethics Committee will be applied in order to obtain their consent to
carry out the study. The is approved by the Data Protection Agency for permission for data
recording and storage of data. The data will be rendered anonymous through a code system and
stored safely in accordance with applicable rules of the organizers. The study follows the
general research ethics rules as expressed in the Helsinki Declaration II ("World Medical
Association Declaration of Helsinki: Ethical Principles for Medical Research involving Human
Subjects," 2000).
Passed on information from the patient journal system Patient data as mentioned below will be
passed on from the electronic patient files to the project.
Gender, age, marital status, comorbidities and smoking status will be passed on at the
beginning of the study to compare the data at the end of the trial.
Telephone number, address and or E-mail from participants in the focus group will be passed
on with the goal to contact the participant in the case there is a break in the connection
via the tele rehab devices or if we need to send a new updated devices.
Health status, number of exacerbations in the last period, days of hospitalization, number of
visits to the hospital or number of visits from healthcare suppliers to participants at home
will be used to calculate the health care expenditure for each participant.
Economy MD, Ph.D. Elisabeth Bendstrup, MD Anders Løkke, MD, ph.d. Ole Hilberg and
physiotherapist José Cerdan has initiated this project and sought various foundations to
execute this study.
Elisabeth Bendstrup, Anders Løkke and Ole Hilberg are the responsibles of the investigation
for this study and have no financial ties to the donors.
The study is predominantly financed by EURO STARS Foundation (1,500,000 kr.) and Aarhus
University (about 450,000 kr.).
Physio R & D, Laster Technologies, Cortrium and bookBeo are providing the the technology,
network, hardware, software and support needed for free.
Aarhus University Hospital provides locations and resources as needed and pays for the costs
of the control group training. Aarhus University Hospital is also responsible for the
administration and disbursement of funding.
Enrolled participants do not receive honorees for participating in this study. Transport
costs associated with the trial will be covered by Aarhus University Hospital.
