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

Heart Failure Clinical Trial

— TCN  

Official title:

Effectiveness and Cost-effectiveness of Telemedicine for Heart Failure: The Danish "TeleCare North" Pragmatic Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860013
• Other study ID #: telecare nord heart failure
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2023
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All heart failure patients that may benefit from telehealthcare.

• Participants are qualified for inclusion if they have been diagnosed with HF according to national guidelines and are NYHA classified 2,3, and 4.

• 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.

Exclusion Criteria:

• 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.

• Comorbidity is not an exclusion criterion.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Telemedicine

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in daily functioning (KCCQ questionnaire score)	Changes in daily functioning measured by KCCQ questionnaire score.	12 month follow-up
Secondary	Physical health related quality of life (SF-36 questionnaire Physical scores)	Changes in physical health-related quality of life (SF-36 questionnaire physical score) at baseline to follow-up.	12 month follow-up