Clinical trial NCT01752192: Teledi@Log - Tele-rehabilitation of Heart Patients
Official title: Tele-rehabilitation of Heart Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Myocardial Infarction
Angina Pectoris
Coronary Stenosis
Mitral Valve Stenosis
Keywords: Rehabilitation
Telemedicine
Heart patients
Social media
Organisational aspects
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: KMD
name: International Business Machines (IBM)
name: Tunstall Healthcare
name: Oscar Film
name: Roche Pharma AG
name: SOS International
name: Danish Heart Foundation
name: Hjoerring Municipaility
name: Frederikshavn Municipality
name: Regionshospital Nordjylland
name: Aalborg University Hospital
name: University of Aarhus
name: GP in the Municipalities of Hjoerring and Frederikshavn
name: EIR (Empowering Industry and Research)
First posted: 2012-12-19
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: At inclusion (baseline), change from baseline at 3, 6 and 12 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At inclusion (baseline), change from baseline at 3, 6 and 12 months
measure: Self-determination
timeFrame: At inclusion (baseline), change from baseline at 3, 6 and 12 months
measure: Health outcome EQ 5
timeFrame: At inclusion (baseline), change from baseline at 3, 6 and 12 months
measure: Health economical evaluation
timeFrame: At inclusion (baseline), change from baseline at 3, 6 and 12 months
measure: Interorganizational aspects of a telerehabilitation programme
timeFrame: Cnanges during 2012-2014
measure: Social media for telerehabilitation
timeFrame: Changes within 3 months
Other outcomes:
measure: Perception of health
timeFrame: At inclusion (baseline), changes from baseline at 3, 6 and 12 months
measure: Steps taken
timeFrame: At inclusion (baseline) and changes from baseline will be indtified
measure: Qualitative perceptions of telerehabilitation
timeFrame: Changes within 3 months
Locations:
city: Aalborg
country: Denmark
facility: Thoracic Ward, Aalborg University Hospital
city: Hjoerring
country: Denmark
facility: Cardiology Ward Vendyssel Hospital
Study officials:
affiliation: Aalborg University
name: Birthe Dinesen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dithmer M, Rasmussen JO, Gronvall E, Spindler H, Hansen J, Nielsen G, Sorensen 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. Epub 2015 Nov 18.
citation: 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, Vol. 15, Nr. ETC Conf. Suppl., 2015.
citation: 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: International Journal of Integrated Care, Vol. 15, Nr. ETC Conf. Suppl., 2015.
citation: 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.
citation: 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, Vol. 13, Nr. Suppl. 1, 2014, s. S17.
citation: 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, CIMT, Middelfart, Danmark.
citation: 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 Innovativ Medicinsk Teknologi, CIMT, Middelfart, Danmark.
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 Informatics 2013, 20 August 2013, Copenhagen, Denmark. red. / Gustav Bellika; Ann Bygholm; Mette Dencker; Mariann Fossum; Gert Galster; Gunnar Hartvigsen; Ole Hejlesen; Daniel Karlsson; Sabine Koch; Carl-Erik Moe. Linköping University Electronic Press, 2013. s. 51-54 (Linköping Electronic Conference Proceedings; Nr. 91).
citation: 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 April 2012, Luxembourg. red. / Malina Jordanova; Frank Lievens. Vol. 5 International Society for Telemedicine & eHealth, 2012. s. 611-614 ( Global Telemedicine and eHealth Updates : Knowledge Resources, Vol. 5).
citation: 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 Telemedicine & eHealth, 2012. s. 123.
citation: Dinesen B, Spindler H. The Use of Telerehabilitation Technologies for Cardiac Patients to Improve Rehabilitation Activities and Unify Organizations: Qualitative Study. JMIR Rehabil Assist Technol. 2018 Nov 19;5(2):e10758. doi: 10.2196/10758.
citation: Thorup C, Hansen J, Gronkjaer M, Andreasen JJ, Nielsen G, Sorensen EE, Dinesen BI. Cardiac Patients' Walking Activity Determined by a Step Counter in Cardiac Telerehabilitation: Data From the Intervention Arm of a Randomized Controlled Trial. J Med Internet Res. 2016 Apr 4;18(4):e69. doi: 10.2196/jmir.5191.
citation: Kidholm K, Rasmussen MK, Andreasen JJ, Hansen J, Nielsen G, Spindler H, Dinesen B. Cost-Utility Analysis of a Cardiac Telerehabilitation Program: The Teledialog Project. Telemed J E Health. 2016 Jul;22(7):553-63. doi: 10.1089/tmj.2015.0194. Epub 2015 Dec 29.