Motivational nursing intervention on treatment adherence in heart failure patients
| ISRCTN | ISRCTN71548370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71548370 |
| Protocol serial number | N/A |
| Sponsor | Montreal Heart Institute (Institut de cardiologie de Montréal) (Canada) |
| Funders | Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ) (Canada), Ministry of Education, Leisure and Sport (Ministère de léducation, loisirs et sport [MELS]) (Canada) |
- Submission date
- 16/12/2008
- Registration date
- 23/12/2008
- Last edited
- 21/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
R -1520
Montreal Heart Institute Research Center
5000 Bélanger est
Montreal
H1T 1C8
Canada
| Phone | +1 514 376 3330 ext 4012 |
|---|---|
| sylvie.cossette.inf@umontreal.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial, single centre |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effectiveness of a motivational nursing intervention based on the stages of change on treatment adherence in heart failure patients [Évaluation de leffet dune intervention infirmière Motivationnelle Selon les Stades de Changement (MSSC) sur des comportements dauto-soins chez des patients atteints dinsuffisance cardiaque] |
| Study acronym | PROJET MSSC |
| Study objectives | We hypothesise that, compared to the control group, patients in the intervention group will have better self-care behaviour and management, as well as higher levels of confidence and conviction to change their self-care behaviour. |
| Ethics approval(s) | Institut de Cardiologie de Montréal Ethics Committee gave approval on the 14th November 2008 (ref: 08-1074) |
| Health condition(s) or problem(s) studied | Treatment adherence/self-care behaviour in heart failure patients |
| Intervention | The nurse from the heart failure clinic will refer eligible patients to the research nurse. After giving their informed consent, the patients will fill out the baseline questionnaire and will be randomly assigned to either the intervention or control group. Intervention group: The research nurse will meet with patients to evaluate the self-care behaviour that will be targeted by the intervention. The nurse will then start the first intervention by evaluating the patients "stage of change", as well as their confidence and conviction to change. Following this assessment, the nurse will propose stage-specific interventions to help the patient. Those interventions were developed previously in a study on smoking cessation, and have been adapted to our heart failure population. The research nurse will undertake this assessment-intervention process three times: 1. In person prior to the patient's discharge from the heart failure clinic 2. By telephone 4 ± 2 days following discharge, and 3. By telephone 10 ± 2 days following discharge Control group: There will be no specific intervention by the research nurse. The patients will return home and continue with standard-follow up from the heart failure clinic. |
| Intervention type | Other |
| Primary outcome measure(s) |
Self-care frequency and self-care management will be measured at baseline and one month following randomisation using the following measures: |
| Key secondary outcome measure(s) |
The following variables will be measured at baseline and one month following randomisation: |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Aged 18 years or more, either sex 2. Diagnosis of heart failure 3. French language 4. Physical and cognitive ability to answer a written questionnaire and to communicate by telephone 5. Physical and cognitive ability to read and sign a consent form 6. Problems with at least one self-care behaviour for HF patients (exercise, low-salt diet, fluid restriction, daily weight or medication) as evaluated by a clinic nurse |
| Key exclusion criteria | 1. Hospitalised at the time of enrolment 2. Final discharge from the heart failure clinic (i.e. no more follow-up) |
| Date of first enrolment | 24/11/2008 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
H1T 1C8
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |