COPD (Chronic Obstructive Pulmonary Disease)TEMOKAPNCT06988566
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.
A study testing Intervention Group in people with COPD (Chronic Obstructive Pulmonary Disease), run by ECM Klinikken APS at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Sep 2020to 2 Sep 2022
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- unstable heart disease
- poorly regulated diabetes
- diagnosed with psychiatric conditions who leads to mental impaired functions
- unable to communicate in oral and written Danish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemedical Monitoring and Treatment of COPD Patients Associated With General Practice (TEMOKAP)
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.
Read the 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.
- Being tested
- Intervention Group
- 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.
Intervention GroupOther
Also called ECM Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | The placebo group received the usual care provided by the GP and other health relevant stakeholders. Receives: Other: Intervention Group |
| 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. Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From enrollment to the end of treatment at 12 month
Secondary outcomes (1)
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
Measured: From enrollment to the end of treatment at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start4 Sep 2020
- Primary completion1 Jul 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECM Klinikken APS
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Klaus Phanareth, ECM Klinikken APS
- Investigators
- Klaus Phanareth, MD, Ph.D., Principal investigator, ECM Klinikken APS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988566
- Sponsor's protocol ID
- F-24055647
- Acronym
- TEMOKAP
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Publications
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.
PubMed 30698060Kayser 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.
PubMed 30747717Jakobsen 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.
PubMed 25654366Krag 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.
PubMed 37578832Phanareth 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.
PubMed 34665151Phanareth 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.
PubMed 28093379Phanareth 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.
PubMed 41125235
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Monitoring and Treatment of COPD Patients Associated With General Practice (TEMOKAP)
- ClinicalTrials.gov ID
- NCT06988566
- Acronym / sponsor ID
- TEMOKAP / F-24055647
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- ECM Klinikken APSResearch network
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Intervention GroupThe placebo group received the usual care provided by the GP and other health relevant stakeholders. |
| Intervention group | Active comparator | Other: Intervention GroupThe 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- unstable heart disease
- poorly regulated diabetes
- diagnosed with psychiatric conditions who leads to mental impaired functions
- unable to communicate in oral and written Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupAlso: ECM InterventionThe 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. | Other | Intervention group, Placebo group |
Primary outcome
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
Time frame: From enrollment to the end of treatment at 12 month
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
Patients' contacts to healthcare services associated with COPD
Time frame: From enrollment to the end of treatment at 12 month
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.
1 secondary outcome
The Readiness and Enablement Index for Health Technology (READHY)
Time frame: From enrollment to the end of treatment at 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 30698060Rossen 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.
- Background: PubMed 30747717Kayser 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.
- Results publication: PubMed 25654366Jakobsen 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.
- Results publication: PubMed 37578832Krag 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.
- Results publication: PubMed 34665151Phanareth 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.
- Results publication: PubMed 28093379Phanareth 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.
- Derived from this study: PubMed 41125235Phanareth 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.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Phanareth, MD, Ph.D. principal investigator
ECM Klinikken APS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with COPD (Chronic Obstructive Pulmonary Disease), run by ECM Klinikken APS 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From enrollment to the end of treatment at 12 month). The study lists 2 primary outcomes in all. 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 NCT06988566, which also lists 7 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 3 Jun 2025.