Telemedicine for Patients Suffering From Heart Failure (Danish Telecare North Trial)

NCT02860013 | Completed

• 1 other identifier: telecare nord heart failure
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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 Heart Failure 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 Heart Failure across patients and municipality districts. It is hypothesized that telehealth care will increase patients quality adjusted life years 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.

Conditions

Heart Failure

Keywords

Telemedicine; Effectiveness; Cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• Mental health related quality of life (SF-36 questionnaire mental scores)

  Changes in mental health-related quality of life (SF-36 questionnaire mental score) at baseline to follow-up.

  12 month follow-up

• Incremental cost-effectiveness ratio (ICER)

  The main outcome for cost is incremental cost-effectiveness ratio (ICER). ICER is measured as the total cost per quality adjusted life years (QALY) increased from baseline to follow-up.

  12 month follow-up

Secondary Outcomes (2)

• Changes in daily functioning (KCCQ questionnaire score)

  12 month follow-up

• Physical health related quality of life (SF-36 questionnaire Physical scores)

  12 month follow-up

Study Arms (2)

Telemedicine

ACTIVE COMPARATOR

A tablet (a Samsung GALAXY TAB 2 (10.1)) that holds information on handling heart failure in general. The device can also collect and transmit relevant disease-specific data, which are indicative of their current state of health, via 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, and weight. The tablet can be activated and give a sound, when it is time for taking measurements again.

Device: Telemedicine

Usual care

NO INTERVENTION

In Denmark, usual practice for treating, monitoring and caring for patients with heart failure are the responsibility of the patient's general practitioner (treatment and monitoring) and the municipalities (practical help and nursing care). Heart failure patients can make appointments with their general practitioner or practice nurse free of charge in order to get help in managing heart failure. Community based care and practical help varies. As a rule community care comes at regular intervals based on a clinically based estimate of the patients' needs, but the personnel are not necessarily certified nurses and often not fully educated in heart failure and definitely not on call

Interventions

Telemedicine DEVICE

Telemedicine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All heart failure patients that may benefit from telehealthcare.
• Patients must have a permanent residence and be motivated for using telehealthcare. \*Patients must have a landline or mobile phone and be able to speak Danish or they must live with a relative speaking Danish. Such that the relative must be able to help the patient in translating the information in the use of telehealthcare.

You may not qualify if:

• Patients without landline phone / mobile phone or GSM (Global System for Mobile Communications) coverage.
• Patients not able to understand Danish adequately to complete the questionnaires in the study or patients having a cognitive impairment.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, Denmark

Location

Related Publications (3)

• Vestergaard AS, Hansen L, Sorensen SS, Jensen MB, Ehlers LH. Is telehealthcare for heart failure patients cost-effective? An economic evaluation alongside the Danish TeleCare North heart failure trial. BMJ Open. 2020 Jan 27;10(1):e031670. doi: 10.1136/bmjopen-2019-031670.

  PMID: 31992604 DERIVED

• Cichosz SL, Udsen FW, Hejlesen O. The impact of telehealth care on health-related quality of life of patients with heart failure: Results from the Danish TeleCare North heart failure trial. J Telemed Telecare. 2020 Aug-Sep;26(7-8):452-461. doi: 10.1177/1357633X19832713. Epub 2019 Apr 11.

  PMID: 30975047 DERIVED

• Cichosz SL, Ehlers LH, Hejlesen O. Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):590. doi: 10.1186/s13063-016-1722-5.

  PMID: 27955682 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 9, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)