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Pulmonary Disease, Chronic Obstructive2-TELEKOLNCT03443817

Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up

A study testing Tele rehab in people with Pulmonary Disease, Chronic Obstructive, run by University of Aarhus at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Introduction In order to guarantee chronic patients \& elderly a high quality service from health care organizations in the coming decades, new technologies have been implemented to treat patients from a distance. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Tele rehab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteDenmark
Study dates
1 Mar 2018to 30 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stable COPD
  • Signed informed consent
  • Completion of the standard rehabilitation program
  • Permanent oxygen therapy is not an obstacle for participation.

Who cannot join

  • The patient has significant musculoskeletal disorders that limit his / her function levels to a degree that is not caused by dyspnea
  • The patient has pronounced dizziness, significant sensory or motor disability, dementia or terminal malignant disease
  • Serious comorbidities (unstable heart disease, irregular diabetes, known malignant disease, another disease that makes the patient unfit to participate in the study).
  • Non-compliant patient (eg. Nursing Homes Residents)
  • Participation in another project within the last 30 days
  • Mini-Mental State Examination score less than 24 points
Show all 15Show fewer
  • Severe vision or hearing loss.
  • Non-Danish speaking.
  • Lack of will to implement the protocol.
  • Motor or sensory disease, which makes it impossible for walk training
  • Have experienced a worsening in the last 4-6 weeks
  • Musculoskeletal disorders
  • Serious heart diseases (ejection fraction <30%, daily angina, or as indicated by treating the cardiologist)
  • Can not understand informed consent
  • Other factors that inhibit the use of telerehabilitation

Trial locations and contacts

1 site in 1 country.

Jose Cerdan, PhD stud contact

+4530648283

joscer@rm.dk

Elisabeth Bendstrup, MD,Ph.d contact

+45 7846 2201

karbends@rm.dk

Denmark1 site, 1 recruiting
  • Jose Cerdan

    Aarhus, Danmark, 8000

    Jose Cerdan, PhD student, 30648283, joscer@rm.dk

    Elisabeth Bendstrup, PhD, M.D, +45 7846 2201, karbends@rm.dk

    Recruiting

Other trials in Denmark

About this study

Introduction In order to guarantee chronic patients \& 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.

Read more

Method and material The study is a prospective randomized controlled trial comparing the effects of a follow-up tele-rehabilitation program and conventional follow-up rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either an 8 week follow-up tele-rehabilitation program or to standard follow up after rehabilitation. Participants will be tested at baseline, after 8 weeks 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.

Read the detailed description

Intro

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.

TR 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 et al., 2013), knee (Cabana et al., 2010) (Tousignant, Moffet, et al., 2011) (Tousignant, Boissy, et al., 2011) and shoulder (Eriksson et al., 2009)(Eriksson, Lindström and 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 et al., 2011)(Parker and Thorslund, 2007)(Yach, Hawkes, Gould, and Hofman, 2004). Such facts points to the need of creating and improving solution 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 on 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, Juel and Kamper-Jørgensen, 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 et al., 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 et al., 1995)(Lacasse et al., 2009)(Nava, 1998)(Simpson et al., 1992), quality of life (Wijkstra et al., 1995)(Bendstrup et al., 1997), long-term survival (Godoy, 2007), sputum clearance (Garrod and Lasserson, 2007) (Oldenburg et al., 1979); Health-related quality of life (Almagro and Castro, 2013) (Blackstock et al., 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 et al., 2008) (Wedzicha et al., 1998), exercise capacity, endurance (Lacasse, Guyatt and Goldstein, 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, Guyatt and Goldstein, 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 et al., 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 et al., 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, Huniche and Toft, 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 and Sppath, 2010).

Hypothesis:

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.

To assess and compare the feasibility and effect of a follow-up tele-rehabilitation program after standard COPD rehabilitation with a new and innovative TR platform (NITRP) compared to standard follow-up after 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 after standard COPD rehabilitation with a NITRP compared to the usual follow-up after 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 follow-up tele-rehabilitation after standard COPD rehabilitation compared to follow-up.

The secondary purpose is to investigate the efficacy and cost effectiveness of follow-up tele-rehabilitation after standard COPD rehabilitation with a NITRP compared to usual follow-up 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 after standard COPD rehabilitation are lower or equal compared to conventional rehabilitation response.

Being tested
Tele rehab
Keywords
Feasibility, tele-rehabilitation, follow-up, COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele rehabBehavioural

    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

    Retraining breath: Patients will also be instructed to use different techniques to breath during the video consultations with the physiotherapist.

    Chat Sessions: Each patient has the opportunity to chat with the physiotherapist any time via the chat module of the system.

    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.

    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.

Study groups in NCT03443817
Study groupRoleWhat they receive
Control groupNo interventionThere is no conventional rehabilitation follow up program, but all patients are encouraged to continue training
Intervention groupExperimentalThe intervention group will obtain telerehabilitation
Receives: Behavioral: Tele rehab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 minute walk test

    Change in the 6 minute walk test

    Measured: measured at week 8

Secondary outcomes (5)
  1. 6 minute walk test

    Change in the 6 minute walk test measured 6 months after cessation of the tele-rehabilitation program compared to baseline.

    Measured: 6 months after cessation

  2. Health-related quality of life

    Change in total score in health-related quality of life measured by SGRQ after 8 weeks, and 6 months after cessation of the tele-rehabilitation program compared to baseline.

    Measured: 8 weeks, and 6 months after cessation

  3. Generalised Anxiety Disorder Assessment (GAD-7)

    Change in total score in health-related quality of life measured by GAD-7 after 8 weeks, and 6 months after cessation of the tele-rehabilitation program compared to baseline.

    The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.

    Measured: 8 weeks, and 6 months after cessation

  4. health-related quality of life measured by SGRQ

    Change in component scores (symptoms, activity \& impact) in health-related quality of life measured by SGRQ immediately after, and 6 months after cessation of the tele-rehabilitation program compared to baseline.

    Measured: 6 months after cessation

  5. Cost tele-rehab

    Cost of the tele-rehabilitation program

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2018
  2. Study start1 Mar 2018 (estimated)
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Jan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective randomized controlled trial comparing the effects of a follow-up tele-rehabilitation program and conventional follow-up rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either an 8 week follow-up tele-rehabilitation program or to standard follow up after rehabilitation. Participants will be tested at baseline, after 8 weeks and 6 months after cessation of the training programs. In the intervention group, a real- and a virtual physiotherapist agent will facilitate the rehabilitation.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03443817
Sponsor's protocol ID
2-KOL
Acronym
2-TELEKOL
Status last verified
Feb 2018
First submitted
19 Feb 2018
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The study 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).

Publications

  • Tsai LL, McNamara RJ, Moddel C, Alison JA, McKenzie DK, McKeough ZJ. Home-based telerehabilitation via real-time videoconferencing improves endurance exercise capacity in patients with COPD: The randomized controlled TeleR Study. Respirology. 2017 May;22(4):699-707. doi: 10.1111/resp.12966. Epub 2016 Dec 19.

    PubMed 27992099
  • Zanaboni P, Dinesen B, Hjalmarsen A, Hoaas H, Holland AE, Oliveira CC, Wootton R. Long-term integrated telerehabilitation of COPD Patients: a multicentre randomised controlled trial (iTrain). BMC Pulm Med. 2016 Aug 22;16(1):126. doi: 10.1186/s12890-016-0288-z.

    PubMed 27549782
  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

    PubMed 33511633

Questions about this trial

What is this clinical trial studying?

A study testing Tele rehab in people with Pulmonary Disease, Chronic Obstructive, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jose Cerdan, PhD stud (+4530648283, joscer@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 minute walk test (time frame: measured at week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443817, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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