Teledi@Log - Tele-rehabilitation of Heart Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tele-rehabilitation of Heart Patients

Conditions
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Heart Failure, Myocardial Infarction, Angina Pectoris, Coronary Stenosis, Mitral Valve Stenosis

Intervention / Treatment
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* Device: Telerehabilitation programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation programme<br>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<br>* 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.<br>* Other names: Tablet(Samsung Galaxy Tab 2 10.1);|
| No Intervention: Control group traditional rehabilitation<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At inclusion (baseline), change 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. | At inclusion (baseline), change 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. | At inclusion (baseline), change 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. | At inclusion (baseline), change 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. | Cnanges during 2012-2014 | 
| 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. | Changes within 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Telemedicine, Heart patients, Social media, Organisational aspects