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Effects of telemonitoring after cardiac surgery.


- candidate number8840
- NTR NumberNTR2671
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2010
- Secondary IDsP10-46 METC Enschede
- Public TitleEffects of telemonitoring after cardiac surgery.
- Scientific TitleA randomized intervention study on the effects of telemonitoring in the aftercare of patients after cardiac surgery. A pilot.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedTelemonitoring, Cardiac surgery, Aftercare
- Inclusion criteria1. All patients with CABG, valve surgery and a combination of CABG/valve surgery;
2. Age 55-85 year;
3. Capable to use the equipment.
- Exclusion criteria1. No comprehension of dutch language;
2. Bad mobility;
3. Patients outside the clinical pathway;
4. Patients transferred to other hospitals.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2011
- planned closingdate1-apr-2011
- Target number of participants30
- InterventionsPatients in the intervention group receive aftercare by means of telemonitoring. The control group receives the normal aftercare.
For telemonitoring patients measure their blood pressure and weight daily and make an ECG weekly.
Current aftercare consists of the advice to the patient to contact the general practitioner or the ward. After one month patients are called by the nurse of the ward to be informed on their well-being.
- Primary outcomeQuality of life: Measured with the SF-36 (Aaronson et al., 1998).
- Secondary outcomeNumber of complications and readmissions within four weeks.
- Timepoints1. Quality of life (SF-36) questionnaire. First time at baseline (hospital admission), second time four weeks after discharge;
2. Four weeks after discharge during a phone call patients are interviewed if there have been readmissions and/or complications. Results are recorded in a list.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Broeke, ten
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Grandjean
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summaryThe average time of hospital admission after cardiac surgery, without a patient being transferred to another hospital, is seven days, but depends on the post-operative course. Once returned to their home situation, patientsí recovery is not always well. Questions and concerns may develop, which, if they remain unanswered, hinder the process of recovery. Furthermore, the recognition of symptons and complications is difficult for patients. To offer a patient optimum care, support and safety during the first four weeks after discharge after cardiac surgery, a possibility lies in the use of telemonitoring. This can be achieved by introducing telemonitoring in the aftercare of patients who underwent cardiac surgery. Through telemonitoring it can be recorded if quality of life improves and if complications are detected early. Up to now, no study has been done in the support of patients after cardiac surgery.
This study researches the following effects of telemonitoring with patients after cardiac surgery four weeks after discharge:
1. Quality of life (SF-36);
2. The number of readmissions within four weeks;
3. The number of relevant complication.
The study method is a randomized intervention study. It concerns open randomization with a parallel design. The study is a pilot study which will take approximately 2 to 3 months.
Patients in the intervention group receive aftercare by means of telemonitoring. The control group receives the normal aftercare.
The study is coordinated by Thoraxcentrum Twente, a division of Medisch Spectrum Twente.
The population consists of patients who are admitted for cardiac surgery on the A2 and D2 ward. All patients who will undergo a CABG, valve surgery or a combination of both are qualified to participate in the study.
Patients in the intervention group receive aftercare by means of telemonitoring. The control group receives the normal aftercare.
For telemonitoring patients measure their blood pressure and weight daily and make an ECG weekly.
Current aftercare consists of the advice to the patient to contact the general practitioner or the ward. After one month patients are called by the nurse of the ward to be informed on their well-being.
- Main changes (audit trail)
- RECORD29-dec-2010 - 30-jan-2011


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