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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Aalborg University
Sponsor:
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 Universitetshospital
University of Aarhus
GP in the Municipalities of Hjoerring and Frederikshavn
EIR (Empowering Industry and Research)
Information provided by (Responsible Party):
Birthe Dinesen, Aalborg University
ClinicalTrials.gov Identifier:
NCT01752192
First received: December 12, 2012
Last updated: July 21, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Heart Failure
Myocardial Infarction
Angina Pectoris
Coronary Stenosis
Mitral Valve Stenosis
Device: Telerehabilitation programme

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Tele-rehabilitation of Heart Patients

Resource links provided by NLM:


Further study details as provided by Aalborg University:

Primary Outcome Measures:
  • Quality of life [ Time Frame: At inclusion (baseline), change from baseline at 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: At inclusion (baseline), change from baseline at 3, 6 and 12 months ] [ Designated as safety issue: No ]
    To measure the patients degree of anxiety and depression at baseline (inclusion), changes from baseline at 3, 6 and 12 months.

  • Self-determination [ Time Frame: At inclusion (baseline), change from baseline at 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: At inclusion (baseline), change from baseline at 3, 6 and 12 months ] [ Designated as safety issue: No ]
    To measure health outcome at baseline (inclusion, and changes from baseline at 3, 6 and 12 months.

  • Health economical evaluation [ Time Frame: At inclusion (baseline), change from baseline at 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: January 2013 (baseline) and change from baseline at October 2013 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At baseline ( inclusion) and changes from baseline at 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Perception of health [ Time Frame: At baseline( inclusion) At inclusion (baseline), changes from baseline at 3, 6 and 12 months ] [ Designated as safety issue: No ]
    To identify the patients feeling of their health during telerehabilitation at inclusion(baseline)and changes from baseline at 3, 6 and 12 months will be identified.

  • Steps taken [ Time Frame: At inclusion (baseline) and changes from baseline will be indtified after 3, 6 and 12 months ] [ Designated as safety issue: No ]
    To measure steps taken with a step counter at baseline(inclusion) and At inclusion (baseline), changes from baseline at 3, 6 and 12 months will be identified.

  • Qualitative perceptions of telerehabilitation [ Time Frame: At baseline (inclusion) At inclusion (baseline), changes from baseline at 3, 6 and 12 months. ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 228
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
Other Names:
  • MyMedic (RTX 3370/71)
  • Blood Pressure Monitor
  • Weight Scale
  • FitBit Zip(Stepcounter)
  • Tablet(Samsung Galaxy Tab 2 10.1)
No Intervention: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752192

Contacts
Contact: Birthe Dinesen, PHD +4520515944 bid@hst.aau.dk
Contact: Lars Fog, MD +97640000 lars.fog@rn.dk

Locations
Denmark
Thoracic Ward, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Jan Andreasen, MD PHD    +4599321111    jja@rn.dk   
Principal Investigator: Jan Andreasen, MD PHD         
Cardiology Ward Vendyssel Hospital Recruiting
Hjoerring, Denmark, 9800
Contact: Gitte Nielsen, MD PhD    +4597640000    gitte.nielsen@rn.dk   
Contact: Lars Fog, MD       lars.fog@rn.dk   
Principal Investigator: Gitte Nielsen, MD PhD         
Sponsors and Collaborators
Aalborg University
KMD
International Business Machines (IBM)
Tunstall Healthcare
Oscar Film
Roche Pharma AG
SOS International
Danish Heart Foundation
Hjoerring Municipaility
Frederikshavn Municipality
Vendsyssel Hospital
Aalborg Universitetshospital
University of Aarhus
GP in the Municipalities of Hjoerring and Frederikshavn
EIR (Empowering Industry and Research)
Investigators
Principal Investigator: Birthe Dinesen, PhD Aalborg University
  More Information

Additional Information:
No publications provided

Responsible Party: Birthe Dinesen, Associate professor, Aalborg University
ClinicalTrials.gov Identifier: NCT01752192     History of Changes
Other Study ID Numbers: N-20120051, N-20120051
Study First Received: December 12, 2012
Last Updated: July 21, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aalborg University:
Rehabilitation
Telemedicine
Heart patients
Social media
Organisational aspects

Additional relevant MeSH terms:
Angina Pectoris
Constriction, Pathologic
Coronary Stenosis
Heart Failure
Infarction
Mitral Valve Stenosis
Myocardial Infarction
Cardiovascular Diseases
Chest Pain
Coronary Disease
Heart Diseases
Heart Valve Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Pathological Conditions, Anatomical
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014