Teledi@Log - Tele-rehabilitation of Heart Patients

NCT01752192 | Completed DMC

• 1 other identifier: N-20120051
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Myocardial Infarction; Angina Pectoris; Coronary Stenosis; Mitral Valve Stenosis

Keywords

Rehabilitation; Telemedicine; Heart patients; Social media; Organisational aspects

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Hospital Anxiety and Depression Scale (HADS)

  At inclusion (baseline), change from baseline at 3, 6 and 12 months

• Self-determination

  At inclusion (baseline), change from baseline at 3, 6 and 12 months

• Health outcome EQ 5

  At inclusion (baseline), change from baseline at 3, 6 and 12 months

• Health economical evaluation

  At inclusion (baseline), change from baseline at 3, 6 and 12 months

• Interorganizational aspects of a telerehabilitation programme

  Cnanges during 2012-2014

Other Outcomes (3)

• Perception of health

  At inclusion (baseline), changes from baseline at 3, 6 and 12 months

• Steps taken

  At inclusion (baseline) and changes from baseline will be indtified

• Qualitative perceptions of telerehabilitation

  Changes within 3 months

Study Arms (2)

Telerehabilitation programme

EXPERIMENTAL

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.

Device: Telerehabilitation programme

Control group traditional rehabilitation

NO INTERVENTION

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.

Interventions

Telerehabilitation programme 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.

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

Telerehabilitation programme

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead
• KMD: collaborator
• International Business Machines (IBM): collaborator
• Tunstall Healthcare: collaborator
• Oscar Film: collaborator
• Roche Pharma AG: collaborator
• SOS International: collaborator
• Danish Heart Foundation: collaborator
• Hjoerring Municipaility: collaborator
• Frederikshavn Municipality: collaborator
• Regionshospital Nordjylland: collaborator
• Aalborg University Hospital: collaborator
• University of Aarhus: collaborator
• GP in the Municipalities of Hjoerring and Frederikshavn: collaborator
• EIR (Empowering Industry and Research): collaborator

Study Sites (2)

Thoracic Ward, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Cardiology Ward Vendyssel Hospital

Hjørring, 9800, Denmark

Location

Related Publications (13)

• 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.

  PMID: 26579590 RESULT

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  PMID: 30455168 DERIVED

• 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.

  PMID: 27044310 DERIVED

• 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.

  PMID: 26713491 DERIVED

Related Links

• Homepage for the study

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction; Angina Pectoris; Coronary Stenosis; Mitral Valve Stenosis

Interventions

Blood Pressure Monitors

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Coronary Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Sphygmomanometers; Diagnostic Equipment; Equipment and Supplies

Study Officials

• Birthe Dinesen, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 19, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

DK (2)