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Heart FailureTeledi@logNCT01752192

Teledi@Log - Tele-rehabilitation of Heart Patients

A study testing Telerehabilitation programme in people with Heart Failure and Myocardial Infarction, run by Aalborg University at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telerehabilitation programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
2 sitesDenmark
Study dates
Dec 2012to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Thoracic Ward, Aalborg University Hospital

    Aalborg, 9000

  • Cardiology Ward Vendyssel Hospital

    Hjørring, 9800

Other trials in Denmark

About this study

Official title: Tele-rehabilitation of Heart Patients

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.

Read the 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.

Being tested
Telerehabilitation programme
Keywords
Rehabilitation, Telemedicine, Heart patients, Social media, Organisational aspects
Medical subject headings
Heart Failure, Myocardial Infarction, Angina Pectoris, Coronary Stenosis, Mitral Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation programmeDevice

    Also called MyMedic (RTX 3370/71), Blood Pressure Monitor, Weight Scale, FitBit Zip(Stepcounter)

    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.

Study groups in NCT01752192
Study groupRoleWhat they receive
Telerehabilitation programmeExperimentalTelerehabilitation 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.
Receives: Device: Telerehabilitation programme
Control group traditional rehabilitationNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. Health outcome EQ 5

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

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

  4. 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.

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

  5. 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.

    Measured: Cnanges during 2012-2014

  6. 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.

    Measured: Changes within 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01752192
Sponsor's protocol ID
N-20120051
Other IDs
N-20120051
Acronym
Teledi@log
Status last verified
Dec 2015
First submitted
12 Dec 2012
Last updated
30 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26579590

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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).

  • 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.

  • 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.

    PubMed 30455168

  • 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.

    PubMed 27044310

  • 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.

    PubMed 26713491

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation programme in people with Heart Failure and Myocardial Infarction, run by Aalborg University at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (time frame: At inclusion (baseline), change from baseline at 3, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01752192, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.

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