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Completed

NCT Number: NCT01752192

Teledi@Log - 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.

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Key information

Conditions

Heart Failure Angina Pectoris Cardiovascular Diseases Chest Pain Coronary Disease Coronary Stenosis Heart Diseases Heart Valve Diseases Infarction Ischemia Mitral Valve Stenosis Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thoracic Ward, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Quality of life

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

    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 outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

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

    To measure the patients degree of anxiety and depression at baseline (inclusion), changes from baseline at 3, 6 and 12 months.

  2. Self-determination

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

    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.

  3. Health outcome EQ 5

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

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

  4. Health economical evaluation

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

    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.

  5. Interorganizational aspects of a telerehabilitation programme

    Time frame: Cnanges during 2012-2014

    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.

  6. Social media for telerehabilitation

    Time frame: Changes within 3 months

    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 outcomes

  1. Perception of health

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

    To identify the patients feeling of their health during telerehabilitation

  2. Steps taken

    Time frame: At inclusion (baseline) and changes from baseline will be indtified

    To measure steps taken with a step counter at baseline(inclusion) and Changes during 12 months

  3. Qualitative perceptions of telerehabilitation

    Time frame: Changes within 3 months

    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

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

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

Registry information

Official study title

Tele-rehabilitation of Heart Patients

Acronym: Teledi@log

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 19, 2012
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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