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.

NCT06988566 | Completed

• 1 other identifier: F-24055647
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• The Readiness and Enablement Index for Health Technology (READHY)

  From enrollment to the end of treatment at 12 month

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

The placebo group received the usual care provided by the GP and other health relevant stakeholders.

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.

Other: Intervention Group

Interventions

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.

Also known as: ECM Intervention

Intervention group; Placebo group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ECM Klinikken APS: lead

Study Sites (1)

The ECM Clinic

Søborg, 2860, Denmark

Location

Related Publications (7)

• 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.

  PMID: 30698060 BACKGROUND

• 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.

  PMID: 30747717 BACKGROUND

• 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.

  PMID: 25654366 BACKGROUND

• 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.

  PMID: 37578832 BACKGROUND

• 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.

  PMID: 34665151 BACKGROUND

• 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.

  PMID: 28093379 BACKGROUND

• 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.

  PMID: 41125235 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus Phanareth, MD, Ph.D.

  ECM Klinikken APS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, Ph.D.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: September 4, 2020
• Primary Completion: July 1, 2022
• Study Completion: September 2, 2022
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DK (1)