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Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up (2-TELEKOL)

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ClinicalTrials.gov Identifier: NCT03443817
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Eurostars
Information provided by (Responsible Party):
University of Aarhus

Brief 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. 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 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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: Tele rehab Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
There is no conventional rehabilitation follow up program, but all patients are encouraged to continue training
Experimental: Intervention group
The intervention group will obtain telerehabilitation
Behavioral: Tele rehab

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.





Primary Outcome Measures :
  1. 6 minute walk test [ Time Frame: measured at week 8 ]
    Change in the 6 minute walk test


Secondary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 6 months after cessation ]
    Change in the 6 minute walk test measured 6 months after cessation of the tele-rehabilitation program compared to baseline.

  2. Health-related quality of life [ Time Frame: 8 weeks, and 6 months after cessation ]
    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.

  3. Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: 8 weeks, and 6 months after cessation ]

    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.


  4. health-related quality of life measured by SGRQ [ Time Frame: 6 months after cessation ]
    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.

  5. Cost tele-rehab [ Time Frame: 6 months ]
    Cost of the tele-rehabilitation program



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443817


Contacts
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Contact: Jose Cerdan, PhD stud +4530648283 joscer@rm.dk
Contact: Elisabeth Bendstrup, MD,Ph.d +45 7846 2201 karbends@rm.dk

Locations
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Denmark
Jose Cerdan Recruiting
Aarhus, Danmark, Denmark, 8000
Contact: Jose Cerdan, PhD student    30648283    joscer@rm.dk   
Contact: Elisabeth Bendstrup, PhD, M.D    +45 7846 2201    karbends@rm.dk   
Sponsors and Collaborators
University of Aarhus
Eurostars
Investigators
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Principal Investigator: Jose Cerdan Aarhus University Hospital

Publications:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03443817     History of Changes
Other Study ID Numbers: 2-KOL
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Feasibility
tele-rehabilitation
follow-up
COPD

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes