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Teledi@Log - Tele-rehabilitation of Heart Patients

Tele-rehabilitation of Heart Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01752192
Acronym
Teledi@log
Enrollment
151
Registered
2012-12-19
Start date
2012-12-31
Completion date
2014-11-30
Last updated
2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Rehabilitation, Telemedicine, Heart patients, Social media, Organisational aspects

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.

Interventions

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of lifeAt inclusion (baseline), change from baseline at 3, 6 and 12 monthsQuality 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

MeasureTime frameDescription
Health outcome EQ 5At inclusion (baseline), change from baseline at 3, 6 and 12 monthsTo measure health outcome at baseline (inclusion, and changes from baseline at 3, 6 and 12 months.
Health economical evaluationAt inclusion (baseline), change from baseline at 3, 6 and 12 monthsAn 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 programmeCnanges during 2012-2014Interorganiszational 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 telerehabilitationChanges within 3 monthsPatients 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.
Hospital Anxiety and Depression Scale (HADS)At inclusion (baseline), change from baseline at 3, 6 and 12 monthsTo measure the patients degree of anxiety and depression at baseline (inclusion), changes from baseline at 3, 6 and 12 months.
Self-determinationAt inclusion (baseline), change from baseline at 3, 6 and 12 monthsQuestionaires 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.

Other

MeasureTime frameDescription
Qualitative perceptions of telerehabilitationChanges within 3 monthsTo 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
Perception of healthAt inclusion (baseline), changes from baseline at 3, 6 and 12 monthsTo identify the patients feeling of their health during telerehabilitation
Steps takenAt inclusion (baseline) and changes from baseline will be indtifiedTo measure steps taken with a step counter at baseline(inclusion) and Changes during 12 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026