Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AØ6-B22-04A
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
McGill University, Montreal QC and Atlantic Health Sciences Corporation, Saint John NB
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Recovery from coronary artery bypass graft surgery
Intervention
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 patients home and the hospital. These daily sessions last approximately 30 minutes each.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
The 20-item State Anxiety Inventory (S-STAI) administered by telephone pre-operatively at baseline and at 5 days and 3 weeks after discharge
Secondary outcome measures
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
Overall trial start date
03/01/2005
Overall trial end date
30/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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 patients 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
174
Participant exclusion criteria
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.
Recruitment start date
03/01/2005
Recruitment end date
30/04/2007
Locations
Countries of recruitment
Canada
Trial participating centre
54 Clipper Passage
Saint John, New Brunswick
E2K0A9
Canada
Sponsor information
Organisation
McGill University (Canada)
Sponsor details
3506 University Street
School of Nursing
Montreal QC
H3A2A7
Canada
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Heart & Stroke Foundation of Canada Fellowship
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
McGill University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Groupe de recherche interuniversitaire
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
en soins infirmiers de Montréal (GRISIM) Fellowship
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list