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ISRCTN
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ISRCTN77474147
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ClinicalTrials.gov identifier
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Public title
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Bridging the transition from hospital to home: Effects of the VITAL Telehealth Program on recovery for CABG patients and their caregivers
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Scientific title
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Acronym
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N/A
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Serial number at source
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AØ6-B22-04A
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Study hypothesis
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1. CABG patients who participate in the VITAL program will have a significantly greater decrease in anxiety between entry into the program and at 2 weeks after program completion as compared to CABG patients who receive usual care.
2. Caregivers of CABG patients who participate in the VITAL program will have a significantly greater decrease in anxiety between entry into the program and at 2 weeks after program completion as compared to caregivers of CABG patients who receive usual care.
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Lay summary
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Not provided at time of registration
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Ethics approval
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McGill University, Montreal QC and Atlantic Health Sciences Corporation, Saint John NB
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Recovery from coronary artery bypass graft surgery
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Participants - inclusion criteria
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1. The patient is undergoing first-time CABG surgery
2. The patient is hospitalized and waiting for CABG surgery, or is admitted to hospital for surgery after being on the cardiac wait list
3. There is a caregiver available and present on admission and/or during the patient’s hospitalization
4. There is a telephone in the home
5. There is a grounded electrical outlet, or three-prong plug outlet, in the home
6. The patient and caregiver speak and understand English and are cognitively able to participate in the interviews
7. Both the patient and caregiver will be likely to be able to adhere with the VITAL program
8. The patient and caregiver both consent to participate
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Participants - exclusion criteria
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1. Patient is scheduled for valve replacement surgery
2. An attending physician believes it is necessary for a patient to have the VITAL program upon discharge.
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Anticipated start date
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03/01/2005
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Anticipated end date
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30/04/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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174
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Interventions
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Participants are randomly assigned to receive usual follow-up care or follow-up care with telehealth equipment. Patients and their caregivers in both groups receive all the usual cardiac teaching that is available during hospitalization. This consists of cardiac instruction from a multidisciplinary health care team on the day of admission to hospital, and on the second, third and fourth post-operative days. Patients are advised to follow-up with their family physician one week after discharge and then to return for a 6 week appointment with the cardiac surgeon.
Caregivers of patients who are assigned to receive follow-up with the telehealth equipment are also provided with two instructional sessions post-operatively and this then enables them to take the equipment home for one week. Having the telehealth equipment at home allows for daily audio-video visits between a patient’s home and the hospital. These daily sessions last approximately 30 minutes each.
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Primary outcome measure(s)
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The 20-item State Anxiety Inventory (S-STAI) administered by telephone pre-operatively at baseline and at 5 days and 3 weeks after discharge
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Secondary outcome measure(s)
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1. Center for Epidemiologic Studies Depression Scale -10 (CESD-10) administered pre-operatively at baseline and at 5 days and 3 weeks after discharge
2. Health Care Utilization data collected at 5 days and 3 weeks after discharge
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Sources of funding
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1. Heart & Stroke Foundation of Canada Fellowship
2. McGill University
3. Groupe de recherche interuniversitaire
en soins infirmiers de Montréal (GRISIM) Fellowship
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Trial website
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Publications
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Contact name
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Mrs
Lisa
Keeping
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Address
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54 Clipper Passage
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City/town
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Saint John, New Brunswick
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Zip/Postcode
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E2K0A9
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Country
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Canada
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Sponsor
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McGill University (Canada)
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Address
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3506 University Street
School of Nursing
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City/town
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Montreal QC
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Zip/Postcode
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H3A2A7
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Country
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Canada
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Sponsor website:
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http://www.nursing.mcgill.ca/
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Date applied
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06/09/2005
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Last edited
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04/08/2011
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Date ISRCTN assigned
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13/09/2005
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