Remote Monitoring of Patients With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2021-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This clinical investigation will evaluate the patient-equipment interface and patient preference in the use of modern possibilities for remote monitoring of patients with COPD in a personalized care approach.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Telemetry-assisted Care in Home Home Vented COPD

NCT05287555

Chronic Obstructive Pulmonary Disease

COMPLETED NA

A Wearable and a Self-management Application for Chronic Obstructive Pulmonary Disease (COPD) Patients at Home

NCT03857061

Pulmonary Disease, Chronic Obstructive

COMPLETED

Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

NCT01522859

Chronic Obstructive Pulmonary Disease

COMPLETED NA

Telemonitoring of Patients With COPD in Carinthia

NCT01580072

Pulmonary Disease, Chronic Obstructive (COPD)

COMPLETED NA

Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)

NCT04369885

Pulmonary Disease, Chronic Obstructive

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective is to evaluate the impact and feasibility of tele monitoring and video contact in personalized care of moderate and severe COPD patients. This should be compared to normal standards of care. The cross-over design evaluates the influence on general HRQOL of this tablet and monitoring system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This clinical trial is an open, randomized, controlled cross-over study. Eligible subjects to include will be given the possibility to participate in the study. They will at their first visit be randomized to start either telemonitoring, using the tablet system arm or to normal standard of care period for 26 weeks. After 26 weeks the subject will have a second visit and after that, four weeks (wash out) of standard of care or telemonitoring treatment. After that there will be a third visit and the subject will start the second treatment period with the alternative management. At the end of this period (56 weeks) there will be a fourth (last) visit at the center for the subject.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal Care

During normal care the subjects will get the possibility to call the COPD-center via telephone on their own initiative e g with worsening symptoms as usual.

Group Type ACTIVE_COMPARATOR

Normal Care

Intervention Type OTHER

During normal care the subjects will get the possibility to call the COPD-center via telephone on their own initiative e g with worsening symptoms as usual.

Telemonitoring

Twice a week subject will perform additional vital functions:

Blood pressure and heart rate will be measured using the Electronic Sphygmomanometers "Track".

Weight will be taken using the Scale "lite" Oxygen saturation will be measured using Pulse Oximeter "Air" And

Complete two PRO´s (integrated in the application):

CAT MRC All this is estimated to take approximately 20-30 min each time.

For the first 4 weeks there will be weekly video calls with a COPD-center nurse discussing health condition and vital parameters.

Thereafter there will be monthly video calls with a COPD-center nurse for the remaining 5 months, i.e. 4 further calls. The video calls will take approximately 15 min.

Group Type ACTIVE_COMPARATOR

Telemonitoring

Intervention Type DEVICE

During the telemonitoring treatment period the subjects will register; vital functions (blood pressure, heart rate, weight, SpO2) twice a week, physical movement daily by using a fitness device, have video calls with a nurse weekly the first 4 weeks and thereafter every fourth week the last 5 months. Twice a week (± 2 days) questionnaires (CAT and MRC) should be filled out at home.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telemonitoring

During the telemonitoring treatment period the subjects will register; vital functions (blood pressure, heart rate, weight, SpO2) twice a week, physical movement daily by using a fitness device, have video calls with a nurse weekly the first 4 weeks and thereafter every fourth week the last 5 months. Twice a week (± 2 days) questionnaires (CAT and MRC) should be filled out at home.

Intervention Type DEVICE

Normal Care

During normal care the subjects will get the possibility to call the COPD-center via telephone on their own initiative e g with worsening symptoms as usual.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willingness to participate and provision of informed consent
* Diagnosis of COPD
* FEV1/FVC (post bronchodilator) \<0.7
* GOLD severity grade D
* FEV, \< 80% predicted
* Cognitive ability relevant for the studies as judged by the investigator
* Living in their own home and able to manage their activities of daily living

Exclusion Criteria

* Rapidly progressing severe disease other than COPD and COPD-related diseases, influencing the Health-Related Quality of Life (HRQOL) during the study time as judged by the investigator
* Long-term stay ( \>2 weeks) away from home during the study period, where there are no possibility to get internet connection
* COPD exacerbation during 1 month before start of study

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No