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The purpose of this study (The TEMOKAP study) is to investigate whether home-based treatment with telemedicine and support from healthcare professionals can prevent acute exacerbations of COPD and avoid acute hospital admissions, and whether this will improve the participant's health status and quality of life. In other words, the project seeks to document how life with COPD can be made better and safer for all COPD patients.
The project is a collaboration between the University of Copenhagen, alles Lægehus (everyone's medical practice), Epital Health A/S, and Apopro.dk and will be conducted as a scientific study.
Why the TEMOKAP Study? The TEMOKAP study represents a new treatment method where, with the help of modern technology and telemedicine, we can offer examination and treatment in your own home if a medical issue or an acute exacerbation of your chronic illness should arise. In a time of Corona, as Denmark is experiencing, this principle is fully in line with the Danish Health Authority's recommendations to protect our chronic patients and reduce the risk of infection.
What are the benefits of participating?
As a participant in the TEMOKAP study, in addition to your usual medication, you will have two types of "acute medication" (antibiotics and corticosteroids) readily available at home. This means that our doctors and nurses can initiate treatment immediately if an exacerbation should occur. You avoid a lot of hassle with getting prescriptions and picking up medication at the pharmacy - and most importantly, you save time and can start treatment quickly. TEMOKAP study, participant information (v3) 2 The TEMOKAP study also has a strong focus on your well-being and safety and therefore offers an open emergency line where you can get in touch with qualified healthcare professionals who are always ready if you need help or support in your daily life.
What does participation involve? Initially, you will undergo a clinical examination by a doctor or nurse from the TEMOKAP study with a special focus on your COPD. We will adjust your medication if necessary, and together we will make a plan for your wishes and goals for the future. You will then decide whether you wish to participate in the TEMOKAP study, and if you meet the necessary criteria for participation, you will need to sign a "Consent Form". Once signed, you will be randomly placed in either an "active group" or a "control group".
Active group As a participant in the "active group", you will be provided with an electronic screen (tablet) with a direct connection to the TEMOKAP study's doctors and nurses, as well as a spirometer and an oximeter. You will be trained in how to use the equipment to take your daily measurements and learn how to contact us if you need to.
Treatment, access to doctors and nurses, all technical equipment, and the delivery of medication are completely free for you. The only thing you have to pay for is your usual medication and the acute medication that you need to have readily available at home. The acute medication costs approximately DKK 50 after subsidy.
Electronic screen (tablet) Spirometer Oximeter Your participation in the TEMOKAP study will last for one year. At the start of the project, after 6 months, and at the end of the project, we will collect a series of health information about your health, which we will analyze to investigate how you have been and to compare with a "control group". This will take place a total of three times, through questionnaires and consultations that you will be invited to.
You will continue to be affiliated with alles LægeHus, so you can contact and visit your own doctor, just as you usually do, and if you are connected to a hospital outpatient clinic, this will also continue - as usual.
Control group As a participant in the "control group", you will continue your treatment as usual through alles LægeHus. At the start of the project, after 6 months, and at the end of the project after 1 year, you will be contacted by one of the TEMOKAP study's staff members who will collect a series of health information about your health to investigate and analyze how you have been. The results will be compared with the "Active group" to investigate the effect of the two treatments. This will take place a total of three times, through questionnaires and consultations that you will be invited to or called about.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | The placebo group received the usual care provided by the GP and other health relevant stakeholders. |
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| Intervention group | Active Comparator | The intervention were connected to the ECM response and coordination centre (RCC) which provided the participants with 24/7/365 access to assistance from certified RCC staff who were supported by eDoctors. Patients self-tracking activities (saturation, pulse, lung function, temperature and report on increased sputum, coughing, and shortness of breath) were monitored dayly by the RCC whoom would contact them in the event of signs of deterioration. The RCC staff together with the participant would make informed decisions, via phone or video call, on how to best manage the change in condition guided by the previous measures evaluated with graphs, including plotted trends. If there was a need for medical treatment, a treatment plan was drawn up with fixed follow-ups and a course plan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Other | The intervention were connected to the ECM response and coordination centre (RCC) which provided the participants with 24/7/365 access to assistance from certified RCC staff who were supported by eDoctors. Patients self-tracking activities (saturation, pulse, lung function, temperature and report on increased sputum, coughing, and shortness of breath) were monitored dayly by the RCC whoom would contact them in the event of signs of deterioration. The RCC staff together with the participant would make informed decisions, via phone or video call, on how to best manage the change in condition guided by the previous measures evaluated with graphs, including plotted trends. If there was a need for medical treatment, a treatment plan was drawn up with fixed follow-ups and a course plan. |
| Measure | Description | Time Frame |
|---|---|---|
| WHO-5 Well-Being Index and 1b: Contacts to healthcare services associated with COPD, 1c: The Readiness and Enablement Index for Health Technology (READHY) questionnaire | Patient's mental well-being was assessed by the WHO-5 Well-Being Index. This is a validated questionnaire that examines patients' mental well-being and can also indicate anxiety, stress, and depression. 1b: Patients' contacts to healthcare services associated with COPD included general practice (GP), out-of-offices services, outpatient clinics and hospital admissions at T0, T1 and T2 in both groups. Baseline information on hospital admissions was also examined retrospectively 12 months from the date of inclusion. Data are only self-reported but were verified by the clinical co-investigators with interviews to ensure that the COPD-related outcomes were accurate. 1c: The Readiness and Enablement Index for Health Technology (READHY) allows for a more systematic assessment of patient readiness for health technology, which includes dimensions of self-management capabilities (including emotional distress), perceived support and digital health literacy. Together with socio-demographic | From enrollment to the end of treatment at 12 month |
| Patients' contacts to healthcare services associated with COPD | Patients' contacts to healthcare services associated with COPD included general practice (GP), out-of-offices services, outpatient clinics and hospital admissions at T0, T1 and T2 in both groups. Baseline information on hospital admissions was also examined retrospectively 12 months from the date of inclusion. Data are only self-reported but were verified by the clinical co-investigators with interviews to ensure that the COPD-related outcomes were accurate. | From enrollment to the end of treatment at 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| The Readiness and Enablement Index for Health Technology (READHY) | The Readiness and Enablement Index for Health Technology (READHY) allows for a more systematic assessment of patient readiness for health technology, which includes dimensions of self-management capabilities (including emotional distress), perceived support and digital health literacy. Together with socio-demographic | From enrollment to the end of treatment at 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Phanareth, MD, Ph.D. | ECM Klinikken APS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The ECM Clinic | Søborg | 2860 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30698060 | Background | Rossen S, Kayser L, Vibe-Petersen J, Ried-Larsen M, Christensen JF. Technology in exercise-based cancer rehabilitation: a cross-sectional study of receptiveness and readiness for e-Health utilization in Danish cancer rehabilitation. Acta Oncol. 2019 May;58(5):610-618. doi: 10.1080/0284186X.2018.1562213. Epub 2019 Jan 30. | |
| 30747717 |
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All IPD collected throughout the trial
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| Kayser L, Rossen S, Karnoe A, Elsworth G, Vibe-Petersen J, Christensen JF, Ried-Larsen M, Osborne RH. Development of the Multidimensional Readiness and Enablement Index for Health Technology (READHY) Tool to Measure Individuals' Health Technology Readiness: Initial Testing in a Cancer Rehabilitation Setting. J Med Internet Res. 2019 Feb 12;21(2):e10377. doi: 10.2196/10377. |
| 25654366 | Result | Jakobsen AS, Laursen LC, Rydahl-Hansen S, Ostergaard B, Gerds TA, Emme C, Schou L, Phanareth K. Home-based telehealth hospitalization for exacerbation of chronic obstructive pulmonary disease: findings from "the virtual hospital" trial. Telemed J E Health. 2015 May;21(5):364-73. doi: 10.1089/tmj.2014.0098. Epub 2015 Feb 5. |
| 37578832 | Result | Krag T, Jorgensen EH, Phanareth K, Kayser L. Experiences With In-Person and Virtual Health Care Services for People With Chronic Obstructive Pulmonary Disease: Qualitative Study. JMIR Rehabil Assist Technol. 2023 Aug 14;10:e43237. doi: 10.2196/43237. |
| 34665151 | Result | Phanareth K, Dam AL, Hansen MABC, Lindskrog S, Vingtoft S, Kayser L. Revealing the Nature of Chronic Obstructive Pulmonary Disease Using Self-tracking and Analysis of Contact Patterns: Longitudinal Study. J Med Internet Res. 2021 Oct 19;23(10):e22567. doi: 10.2196/22567. |
| 28093379 | Result | Phanareth K, Vingtoft S, Christensen AS, Nielsen JS, Svenstrup J, Berntsen GK, Newman SP, Kayser L. The Epital Care Model: A New Person-Centered Model of Technology-Enabled Integrated Care for People With Long Term Conditions. JMIR Res Protoc. 2017 Jan 16;6(1):e6. doi: 10.2196/resprot.6506. |
| 41125235 | Derived | Phanareth K, Purreskov GT, Nielsen EF, Bentsen AT, Schou L, Newman S, Kayser L. Reduced Chronic Obstructive Pulmonary Disease-Related Utilization of Health Care Services and Increased Social Activities by Patients Offered a 24/7 Accessible Telehealth Service Based on the Epital Care Model: Pragmatic Modified Stepped Wedge Randomized Controlled Trial. J Med Internet Res. 2025 Oct 22;27:e65300. doi: 10.2196/65300. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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