Teledi@Log - Tele-rehabilitation of Heart Patients

Heart Failure Clinical Trial

— Teledi@log  

Official title:

Tele-rehabilitation of Heart Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752192
• Other study ID #: N-20120051
• Secondary ID: N-20120051
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: December 29, 2015
• Start date: December 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The idea behind the Teledi@log consortium is to develop tele-rehabilitation concepts and technologies so that all types of heart disease patients, regardless of degree of severity, can be offered individual, customized and coordinated tele-rehabilitation across sectors. The project is innovative, breaking new ground in relation to existing national and international research projects in the area. The Teledi@log consortium sees its major task as developing and testing scenarios which can lead to a more coherent rehabilitation for heart patients in areas such as patient training, organization across the boundaries of the health system and using tele-rehabilitation technology. The Teledi@log consortium seeks to develop new tele-rehabilitation concepts which bring the patient closer to the health system and thereby promote the heart patient's rehabilitation, giving the patient and their families a more active role via new tele-rehabilitation technologies.The hypothesis of the study is that heart patients participating in a telerehabilitation program will have a higher quality of life compared to heart patients following traditional rehabilitation activities.

Description:

The aims of the research project are:

To assess the heart patients' and family members' needs for rehabilitation in the health system

To assess the need for coordination of the rehabilitation effort in the health system

To develop tele-rehabilitation concepts and technologies for heart patients, family members and health professionals in the health sector

To promote an early, rapid and effective rehabilitation of heart patients to improve their daily life and working life.

To prevent re-hospitalization of heart patients through a more individualized and differentiated rehabilitation effort using tele-rehabilitation technologies.

To conduct a randomized study of a tele-rehabilitation concept using tele-rehabilitation technologies and to assess the clinical, technical, organizational and health-economic effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women and men above 18 years

• Must have signed the "Informed Consent" document

• Must be able to understand study information

• Must live in Hjørring or Frederikshavn Kommune

• Must have mobile network

• Must be able to use IT or have a near person who can use IT

• Patients with clinical diagnosis of Heart Failure, Myocardial Infarction, Angina Pectoris, patients who have had Coronary-Artery Bypass Surgery.

Exclusion Criteria:

• Patients who, according to investigator, will not be able to participate in the study

• Lack of ability to speak and understand Danish

• Pregnancy or nursing

• Neurologic disease

• Use of wheelchair/lack of ability to walk

• Participation in other studies which can influence the outcomes of this study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Angina Pectoris
• Constriction, Pathologic
• Coronary Stenosis
• Heart Failure
• Mitral Valve Stenosis
• Myocardial Infarction

Intervention

Device:
• Telerehabilitation programme
Telerehabilitation programme: Each patient in the intervention group will use a telehealth monitor. The patient will measure blood pressure, pulse and weight once or twice a week over a 3 months periode with the use of a blood pressure monitor and a weightscale connected to the monitor. The patients will also measure their steps daily by the use of a digital stepcounter. The patients will be able to see their data in a personal health record on a tablet where they can share informations with their GP, nurse and doctor at the hospital or healthcare center. The patient are also offered access to a portal called www.aktivehjerte.dk where they can find informations on rehabilitations topics in text, video and sound.

Locations

Country	Name	City	State
Denmark	Thoracic Ward, Aalborg University Hospital	Aalborg
Denmark	Cardiology Ward Vendyssel Hospital	Hjoerring

Sponsors (15)

Lead Sponsor	Collaborator
Aalborg University	Aalborg Universitetshospital, Danish Heart Foundation, EIR (Empowering Industry and Research), Frederikshavn Municipality, GP in the Municipalities of Hjoerring and Frederikshavn, Hjoerring Municipaility, International Business Machines (IBM), KMD, Oscar Film, Roche Pharma AG, SOS International, Tunstall Healthcare, University of Aarhus, Vendsyssel Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (10)

Cost-utility analysis of the telerehabilitation of heart patients : the Teledi@log project. / Kidholm, Kristian; Rasmussen, Maja Kjær; Andreasen, Jan Jesper; Hansen, John; Nielsen, Gitte; Dinesen, Birthe Irene. I: International Journal of Integrated Care,

Dithmer M, Rasmussen JO, Grönvall E, Spindler H, Hansen J, Nielsen G, Sørensen SB, Dinesen B. "The Heart Game": Using Gamification as Part of a Telerehabilitation Program for Heart Patients. Games Health J. 2016 Feb;5(1):27-33. doi: 10.1089/g4h.2015.0001. — View Citation

Heart patients' experiences and use of social media in their rehabilitation : a qualitative study. / Jørgensen, Camilla Bech; Hansen, John; Spindler, Helle; Andreasen, Jan Jesper; Nielsen, Gitte; Dinesen, Birthe. Scandinavian Conference on Health Informat

Identification of heart patients' everyday need : Based on user-driven innovation. / Hæsum, Lisa Korsbakke Emtekær; Nielsen, G.; Hangaard, Stine Veje; Hejlesen, Ole; Dinesen, Birthe. Global Telemedicine and eHealth Updates : Knowledge Resources, 18-20 Apr

Pedometer and physical activity for cardiac patients in a telerehabilitation program. / Thorup, Charlotte Brun; Andreasen, Jan Jesper; Dinesen, Birthe; Hansen, John; Grønkjær, Mette; Sørensen, Erik Elgaard. I: European Journal of Cardiovascular Nursing, V

Pedometer use as motivation for physical activity in cardiac tele-rehabilitation. / Thorup, Charlotte Brun; Grønkjær, Mette; Spindler, Helle; Andreasen, Jan Jesper; Hansen, John; Dinesen, Birthe Irene; Nielsen, Gitte; Sørensen, Erik Elgaard. I: Internatio

Personal health record for chronic patient. / Dinesen, Birthe. The International eHealth, Telemedicine and Health ICT Forum for Education, Networking and Business, 18-20 April 2012, Luxembourg: Exhibition and Conference Guide. International Society for Te

Telerehabilitation of cardiac patients : findings from an interdisciplinary telerehabilitation program. / Dinesen, Birthe Irene. I: Telemedicine and e-Health, Vol. 21, Nr. 5, 2015, s. A-59.

Tværsektoriel kommunikationsplatform en gevinst i telerehabilitering af hjertepatienter på tværs af sektorer. / Skov, Christina; Sørensen, Stine Bæk; Dinesen, Birthe. 2014. Abstract from National Konference for Center for Innovativ Medicinsk Teknologi, CI

Udvikling af Aktivthjerte.dk : en digital værktøjskasse til telerehabilitering af hjertepatienter i Teledi@log projektet via en brugerdreven innovations proces. / Dinesen, Birthe; Spindler, Helle. 2014. Abstract from National Konference for Center for Inn

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perception of health	To identify the patients feeling of their health during telerehabilitation	At inclusion (baseline), changes from baseline at 3, 6 and 12 months	No
Other	Steps taken	To measure steps taken with a step counter at baseline(inclusion) and Changes during 12 months	At inclusion (baseline) and changes from baseline will be indtified	No
Other	Qualitative perceptions of telerehabilitation	To explore patients perceptions of participating in a telerehabilitation program at baseline (incluion) and changes from baseline at 3, 6 and 12 months will be identified	Changes within 3 months	No
Primary	Quality of life	Quality of life is measured via the questionaire SF 36 (short form health survey) at baseline (at inclusion) and changes from baseline at 3, 6 and 12 months.	At inclusion (baseline), change from baseline at 3, 6 and 12 months	No
Secondary	Hospital Anxiety and Depression Scale (HADS)	To measure the patients degree of anxiety and depression at baseline (inclusion), changes from baseline at 3, 6 and 12 months.	At inclusion (baseline), change from baseline at 3, 6 and 12 months	No
Secondary	Self-determination	Questionaires on self-determination will be used in order to get an impression of the patients perception on handling their disease at baseline(inclusion)and changes from baseline at 3, 6 and 12 months.	At inclusion (baseline), change from baseline at 3, 6 and 12 months	No
Secondary	Health outcome EQ 5	To measure health outcome at baseline (inclusion, and changes from baseline at 3, 6 and 12 months.	At inclusion (baseline), change from baseline at 3, 6 and 12 months	No
Secondary	Health economical evaluation	An assessment of the economical perspective of the telerehabilitation programme will be performed at baseline (inclusion of patients) and changes from baseline at 3, 6 and 12 months.	At inclusion (baseline), change from baseline at 3, 6 and 12 months	No
Secondary	Interorganizational aspects of a telerehabilitation programme	Interorganiszational aspect of the crosssectional telerehabilitation programme will be explored through observations and qualitative interviews with healthcare professionals at baseline (start of the study) and changes from baseline will be identified in October 2013.	Cnanges during 2012-2014	No
Secondary	Social media for telerehabilitation	Patients use of social media during an rehabilitation process will be explored through interviews at baseline (inclusion) and changes from baseline at 3, 6 and 12 months will be identified.	Changes within 3 months	No

External Links

•   Homepage for the study