Condition category
Surgery
Date applied
06/09/2005
Date assigned
13/09/2005
Last edited
04/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Lisa Keeping

ORCID ID

Contact details

54 Clipper Passage
Saint John
New Brunswick
E2K0A9
Canada

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 patient’s home and the hospital. These daily sessions last approximately 30 minutes each.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

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

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 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

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

http://www.nursing.mcgill.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes