Teledi@Log - Tele-rehabilitation of Heart Patients

NCT ID: NCT01752192

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Heart Failure Myocardial Infarction Angina Pectoris Coronary Stenosis Mitral Valve Stenosis

Keywords

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Rehabilitation Telemedicine Heart patients Social media Organisational aspects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Telerehabilitation programme

Telerehabilitation programme: Each patient will use a telehealth monitor and measure blood pressure, pulse and weight once or twice a week over a 3 months periods 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 step-counter. The patients will be able to see their data in a personal health record on a tablet where they can share informations with healthcare professionals. 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. The patients are randomised in block of different sizes to follow rehabilitation from hospital, healthcare center or a callcenter.

Group Type EXPERIMENTAL

Telerehabilitation programme

Intervention Type DEVICE

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.

Control group traditional rehabilitation

The control group of heart patients follow traditional rehabilitation activities for a period of 3 months.The patients are randomised in block of different sizes to follow rehabilitation from hospital, healthcare center or a callcenter.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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MyMedic (RTX 3370/71) Blood Pressure Monitor Weight Scale FitBit Zip(Stepcounter) Tablet(Samsung Galaxy Tab 2 10.1)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KMD

UNKNOWN

Sponsor Role collaborator

International Business Machines (IBM)

INDUSTRY

Sponsor Role collaborator

Tunstall Healthcare

UNKNOWN

Sponsor Role collaborator

Oscar Film

UNKNOWN

Sponsor Role collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

SOS International

UNKNOWN

Sponsor Role collaborator

Danish Heart Foundation

OTHER

Sponsor Role collaborator

Hjoerring Municipaility

UNKNOWN

Sponsor Role collaborator

Frederikshavn Municipality

UNKNOWN

Sponsor Role collaborator

Regionshospital Nordjylland

OTHER_GOV

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

GP in the Municipalities of Hjoerring and Frederikshavn

UNKNOWN

Sponsor Role collaborator

EIR (Empowering Industry and Research)

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Birthe Dinesen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birthe Dinesen, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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Thoracic Ward, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Cardiology Ward Vendyssel Hospital

Hjørring, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 26579590 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

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).

Reference Type RESULT

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).

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 30455168 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27044310 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26713491 (View on PubMed)

Related Links

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http://teledialog.dk

Homepage for the study

Other Identifiers

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N-20120051

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N-20120051

Identifier Type: -

Identifier Source: org_study_id