Condition category
Not Applicable
Date applied
07/11/2007
Date assigned
05/02/2008
Last edited
21/03/2012
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

Dr Sylvie Cossette

ORCID ID

Contact details

R -1520
Montreal Heart Institute Research Center
5000 Belanger St
Montreal
H1T 1C8
Canada
sylvie.cossette.inf@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FRSQ 10187

Study information

Scientific title

Acronym

TRANSIT-UC

Study hypothesis

It is hypothesised that entering secondary prevention will be more important in the group receiving the intervention than in the control group.

Ethics approval

Ethics approval received from the Montreal Heart Institute Research Ethics Committee on the 11th April 2006 (ref: 06-854).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Facilitation of hospital to home transition after a hospitalisation for Acute Coronary Syndrome (ACS)

Intervention

The research nurse will meet all eligible patients and present the study to them before obtaining informed consent. At the discharge, the participants will be randomly assigned to the intervention or control group. The two groups will answer a questionnaire about the secondary outcomes and the baseline characteristics will be recorded.

Intervention group:
The research nurse will give the discharge care using the study's intervention tool. The intervention will include the following theme:
1. Patient's medication
2. Patient's symptom and complication
3. Patient's care comprehension
4. Patient's adaptation's problem
5. Patient's change of lifestyle
6. Patient's projection in regard to his lifestyle change

Following the assessment, the nurse will propose tailored interventions to the patient for ameliorate the self management of his disease. Those interventions include:
1. Teaching
2. Legitimisation and normalisation
3. Listening and empathy
4. Reassurance
5. Reframing
6. Confrontation
7. Recommendations
8. Warnings
9. Reinforcement
10. Referral to external resources
11. Support to external resources already in place

The research nurse will proceed with this assessment-intervention process thrice:
1. In person at the patient's discharge
2. By telephone 1 - 3 days following discharge
3. By telephone or by a visit of the patient to research centre 8 - 10 days following discharge

Finally, the patient will be able to contact the nurse by telephone during working hours in the 6 weeks following discharge for any concerns he would like to address her.

Control group:
No specific intervention by the research nurse, the discharge care will do by the patient's nurse.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Participant who join in a secondary prevention programme from discharge to 6 weeks.

Secondary outcome measures

The secondary outcomes will be measured at baseline and 6 weeks following randomisation by a telephone interview and are as followed:
1. Medication adherence scale
2. Anxiety
3. Patient's perception of control over the disease and of its consequences
4. Health services utilisation
5. Family support
6. Risk factors

Overall trial start date

03/10/2006

Overall trial end date

03/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female aged 18 years old or more
2. Being discharged from the Coronary Intensive Care Unit (ICU) directly to their home
3. Having the physical and cognitive capacities to answer a written questionnaire and to communicate by telephone
4. Being able to communicate in French or in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

242

Participant exclusion criteria

1. Patient transferred in bypass surgery
2. Hospitalised for more than 7 days
3. Patient transferred in a convalescence centre or living in a prolonged care centre
4. Already having a follow up in specialised clinic

Recruitment start date

03/10/2006

Recruitment end date

03/10/2008

Locations

Countries of recruitment

Canada

Trial participating centre

R -1520
Montreal
H1T 1C8
Canada

Sponsor information

Organisation

Montreal Heart Institute Research Center (Canada)

Sponsor details

5000 Bélanger Street
Montreal
H1T 1C8
Canada
Richard.Maheu@icm-mhi.org

Sponsor type

Research organisation

Website

http://www.icm-mhi.org/en/index.html

Funders

Funder type

Industry

Funder name

AstraZeneca (Canada) (ref: 10187)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Quebec Health Research Fund (Fonds de recherche en Santé du Québec [FRSQ]) (Canada) (ref: 10187)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22282154

Publication citations

  1. Results

    Cossette S, Frasure-Smith N, Dupuis J, Juneau M, Guertin MC, Randomized controlled trial of tailored nursing interventions to improve cardiac rehabilitation enrollment., Nurs Res, 61, 2, 111-120, doi: 10.1097/NNR.0b013e318240dc6b.

Additional files

Editorial Notes