Clinical trial NCT06988566: Reduced COPD Related Utilization of Healthcare Services and Increased Social Activities by Patients Offered a 24/7 Accessible Telehealth Service Based on the Epital Care Model.
Official title: Telemedical Monitoring and Treatment of COPD Patients Associated With General Practice (TEMOKAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Lead sponsor: ECM Klinikken APS
Sponsor class: NETWORK
First posted: 2025-05-25
Enrollment: 184
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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?

* Direct and easy daily access to medical/healthcare professional help regarding your COPD
* The possibility of receiving treatment in the safe environment of your own home
* Free delivery of medication to your home address, so you don't have to go to the pharmacy yourself
* Reduced risk of infection with the Corona virus and other infectious diseases
* Prevention of exacerbations of your COPD and avoidance of hospital admissions
* Increased co-determination in your own treatment process
* Freedom and security to live better with a chronic illness How does it work? The TEMOKAP study works "proactively", meaning it reacts and acts "before the damage is done". This has become possible through the tele-tools that you will be provided with and use daily to take measurements from home. Your measurements are analyzed daily by mathematical models that can help the TEMOKAP study's doctors and nurses predict exacerbations, so they can initiate treatment much earlier than normal.

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.

Eligibility criteria: Inclusion Criteria:

* aged ≥ 45 years
* diagnosed with COPD according to the criteria of the GOLD guideline
* a score of minimum three out of six points in cognitive screening test (The Clock Test + Three-Word Recall Memory Test)
* must have the ability to provide oral or written informed consent
* must have access to the internet in their own home
* must own a smartphone
* must be able to use simple functions in web browsers.

Exclusion Criteria:

* unstable heart disease
* poorly regulated diabetes
* diagnosed with psychiatric conditions who leads to mental impaired functions
* unable to communicate in oral and written Danish.

Primary outcomes:
measure: 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
timeFrame: From enrollment to the end of treatment at 12 month
measure: Patients' contacts to healthcare services associated with COPD
timeFrame: From enrollment to the end of treatment at 12 month
Secondary outcomes:
measure: The Readiness and Enablement Index for Health Technology (READHY)
timeFrame: From enrollment to the end of treatment at 12 month
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: The ECM Clinic
Study officials:
affiliation: ECM Klinikken APS
name: Klaus Phanareth, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.