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Teledi@Log - Tele-rehabilitation of Heart Patients (Teledi@log)

Primary Purpose

Heart Failure, Myocardial Infarction, Angina Pectoris

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telerehabilitation programme
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Rehabilitation, Telemedicine, Heart patients, Social media, Organisational aspects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thoracic Ward, Aalborg University Hospital
  • Cardiology Ward Vendyssel Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telerehabilitation programme

Control group traditional rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Health outcome EQ 5
To measure health outcome at baseline (inclusion, and changes from baseline at 3, 6 and 12 months.
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.
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.
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.

Full Information

First Posted
December 12, 2012
Last Updated
December 29, 2015
Sponsor
Aalborg University
Collaborators
KMD, International Business Machines (IBM), Tunstall Healthcare, Oscar Film, Roche Pharma AG, SOS International, Danish Heart Foundation, Hjoerring Municipaility, Frederikshavn Municipality, Vendsyssel Hospital, Aalborg University Hospital, University of Aarhus, GP in the Municipalities of Hjoerring and Frederikshavn, EIR (Empowering Industry and Research)
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1. Study Identification

Unique Protocol Identification Number
NCT01752192
Brief Title
Teledi@Log - Tele-rehabilitation of Heart Patients
Acronym
Teledi@log
Official Title
Tele-rehabilitation of Heart Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
KMD, International Business Machines (IBM), Tunstall Healthcare, Oscar Film, Roche Pharma AG, SOS International, Danish Heart Foundation, Hjoerring Municipaility, Frederikshavn Municipality, Vendsyssel Hospital, Aalborg University Hospital, University of Aarhus, GP in the Municipalities of Hjoerring and Frederikshavn, EIR (Empowering Industry and Research)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Myocardial Infarction, Angina Pectoris, Coronary Stenosis, Mitral Valve Stenosis
Keywords
Rehabilitation, Telemedicine, Heart patients, Social media, Organisational aspects

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation programme
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group traditional rehabilitation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Telerehabilitation programme
Other Intervention Name(s)
MyMedic (RTX 3370/71), Blood Pressure Monitor, Weight Scale, FitBit Zip(Stepcounter), Tablet(Samsung Galaxy Tab 2 10.1)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
At inclusion (baseline), change from baseline at 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
To measure the patients degree of anxiety and depression at baseline (inclusion), changes from baseline at 3, 6 and 12 months.
Time Frame
At inclusion (baseline), change from baseline at 3, 6 and 12 months
Title
Self-determination
Description
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.
Time Frame
At inclusion (baseline), change from baseline at 3, 6 and 12 months
Title
Health outcome EQ 5
Description
To measure health outcome at baseline (inclusion, and changes from baseline at 3, 6 and 12 months.
Time Frame
At inclusion (baseline), change from baseline at 3, 6 and 12 months
Title
Health economical evaluation
Description
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.
Time Frame
At inclusion (baseline), change from baseline at 3, 6 and 12 months
Title
Interorganizational aspects of a telerehabilitation programme
Description
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.
Time Frame
Cnanges during 2012-2014
Title
Social media for telerehabilitation
Description
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.
Time Frame
Changes within 3 months
Other Pre-specified Outcome Measures:
Title
Perception of health
Description
To identify the patients feeling of their health during telerehabilitation
Time Frame
At inclusion (baseline), changes from baseline at 3, 6 and 12 months
Title
Steps taken
Description
To measure steps taken with a step counter at baseline(inclusion) and Changes during 12 months
Time Frame
At inclusion (baseline) and changes from baseline will be indtified
Title
Qualitative perceptions of telerehabilitation
Description
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
Time Frame
Changes within 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birthe Dinesen, PhD
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoracic Ward, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Cardiology Ward Vendyssel Hospital
City
Hjoerring
ZIP/Postal Code
9800
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26579590
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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).
Results Reference
result
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).
Results Reference
result
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.
Results Reference
result
PubMed Identifier
30455168
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.
Results Reference
derived
PubMed Identifier
27044310
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.
Results Reference
derived
PubMed Identifier
26713491
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.
Results Reference
derived
Links:
URL
http://teledialog.dk
Description
Homepage for the study

Learn more about this trial

Teledi@Log - Tele-rehabilitation of Heart Patients

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