Bridging the transition from hospital to home: Effects of the VITAL Telehealth Program on recovery for CABG patients and their caregivers
| ISRCTN | ISRCTN77474147 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77474147 |
| Protocol serial number | AØ6-B22-04A |
| Sponsor | McGill University (Canada) |
| Funders | Heart & Stroke Foundation of Canada Fellowship, McGill University, Groupe de recherche interuniversitaire, en soins infirmiers de Montréal (GRISIM) Fellowship |
- Submission date
- 06/09/2005
- Registration date
- 13/09/2005
- Last edited
- 04/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Lisa Keeping
Scientific
Scientific
54 Clipper Passage
Saint John, New Brunswick
E2K0A9
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | McGill University, Montreal QC and Atlantic Health Sciences Corporation, Saint John NB |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The 20-item State Anxiety Inventory (S-STAI) administered by telephone pre-operatively at baseline and at 5 days and 3 weeks after discharge |
| Key secondary outcome measure(s) |
1. Center for Epidemiologic Studies Depression Scale -10 (CESD-10) administered pre-operatively at baseline and at 5 days and 3 weeks after discharge |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 174 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 03/01/2005 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
54 Clipper Passage
Saint John, New Brunswick
E2K0A9
Canada
E2K0A9
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
