Telemedicine for Patients Suffering From COPD (Danish Telecare North Trial)

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: Telemedicine

• Registration Number: NCT01984840
• Lead Sponsor: Aalborg University

Brief Summary

There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from COPD that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with COPD across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years at both the cluster and individual level compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-15
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1225

Inclusion Criteria

• diagnosed COPD by spirometry
• in treatment corresponding to GOLD-guidelines
• motivated for treatment of COPD
• COPD is the primary disease
• fixed residence and be affiliated to a general practitioner in North Denmark Region
• At least one of the following criteria should also be met: MRCm (modified) ≥ 2 or MRC ≥3, CAT ≥ 10, have had at least 2 exacerbations within the last 12 months

Exclusion Criteria

• no phone line or GSM coverage
• unable to understand Danish sufficiently to complete study questionnaires
• have a cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine	Telemedicine	A tablet (a Samsung GALAXY TAB 2 (10.1)) that holds information on handling COPD in general and software that automatically instructs the patient in handling COPD during exacerbations. The device can also collect and transmit relevant disease-specific data, which are indicative of their current state of health, via an attached Fingertip Pulse Oximeter (Nonin, Onyx II % SpO2), a Digital Blood Pressure Monitor (Model UA-767, plus BT-C) and a scale. The device can measure four vital signs, which are transferred wirelessly: blood pressure, pulse, blood oxygen saturation and weight. The tablet can be activated and give a sound, when it is time for taking measurements again.

Primary Outcome Measures

Name	Time	Method
Incremental cost-effectiveness ratio (ICER)	12 month follow-up
Health related quality of life	12 month follow-up	SF-36

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Denmark