Feasibility & Effect of a Tele-rehabilitation Program for Chronic Obstructive Pulmonary Disease vs. Standard Rehabilitation
TELEKOL-1
1 other identifier
interventional
54
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJune 26, 2018
June 1, 2018
2.1 years
June 15, 2018
June 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
6 Minutes Walk Test
Change in the 6MWT measured at week 9
9 weeks
Secondary Outcomes (5)
6 Minutes Walk Test
3 and 6 months after cessation of the tele-rehabilitation program
Health-related quality of life SGRQ (in total score)
at week 9, and 3 and 6 months after cessation of the tele-rehabilitation program
Health-related quality of life GAD-7
at week 9, and 3 and 6 months after cessation of the tele-rehabilitation program
Health-related quality of life SGRQ (symptoms, activity & impact)
at week 9, and 3 and 6 months after cessation of the tele-rehabilitation program
Cost of the tele-rehabilitation program
at week 9
Study Arms (2)
Intervention group "tele-rehabilitation"
EXPERIMENTALVideo 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.
Control
ACTIVE COMPARATORCOPD 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.
Interventions
The intervention group will obtain telerehabilitation
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Eurostarscollaborator
Study Sites (1)
Jose Cerdan
Århus C, Danmark, 8000, Denmark
Related Publications (4)
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.
PMID: 27992099RESULTZanaboni 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.
PMID: 27549782RESULTCross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.
PMID: 35514131DERIVEDCox 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.
PMID: 33511633DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Cerdan, PhD student
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2018
First Posted
June 26, 2018
Study Start
March 1, 2017
Primary Completion
March 30, 2019
Study Completion
March 31, 2020
Last Updated
June 26, 2018
Record last verified: 2018-06