Condition category
Circulatory System
Date applied
16/12/2008
Date assigned
23/12/2008
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

Prof Sylvie Cossette

ORCID ID

Contact details

R -1520
Montreal Heart Institute Research Center
5000 Bélanger est
Montreal
H1T 1C8
Canada
+1 514 376 3330 ext 4012
sylvie.cossette.inf@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effectiveness of a motivational nursing intervention based on the stages of change on treatment adherence in heart failure patients [Évaluation de l’effet d’une intervention infirmière Motivationnelle Selon les Stades de Changement (MSSC) sur des comportements d’auto-soins chez des patients atteints d’insuffisance cardiaque]

Acronym

PROJET MSSC

Study hypothesis

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

Institut de Cardiologie de Montréal Ethics Committee gave approval on the 14th November 2008 (ref: 08-1074)

Study design

Randomised controlled trial, single centre

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Self-care frequency and self-care management will be measured at baseline and one month following randomisation using the following measures:
1. The Self-Care of Heart Failure Index (SCHFI) Sections A and B. Section A is an 11-item questionnaire which measures the frequency of self-care behaviours including exercise, low-salt diet, fluid restriction, daily weight or medication using a 4-point Likert scale. A higher score indicates an optimal frequency of self-care behaviours. Section B, a 6-item questionnaire, is divided in three subsections. Section 1 contains one item using a 4-point Likert scale, section 2 contains three items using a 4-point Likert scale and section 3 contains two items using a 5-point Likert scale. Summing these answers provides a total score; higher scores indicate optimal management of self-care.
2. The Therapeutic Self-Care Tool (TSCT) measures the patients' ability to initiate and perform activities aimed at maintaining health, managing health problems, and restoring functioning, using a 12-item questionnaire and a 5-point Likert scale. A higher score indicates better self-care capacities.

Secondary outcome measures

The following variables will be measured at baseline and one month following randomisation:
1. The frequency of specific heart failure self-care behaviours will be measured in the treatment group only, using the Self-Care of Heart Failure Index. To assess this variable, we will use only the item(s) referring to the behaviour on which the intervention is focused. For example, if a patient is focusing on a low salt diet, only the item assessing this self-care behaviour will be retained.
2. Confidence to change will be measured using the Questionnaire of Health Belief. The first subscale, an 8-item questionnaire, uses a 5-point Likert scale to measure the perception of barriers to change. A higher score indicates a higher level of confidence, or fewer barriers.
3. Confidence specific to heart failure patients will be measured using the Self-Care of Heart Failure Index Section C. This is a 6-item questionnaire which uses a 4-point Likert scale to measure confidence in respecting self-care. A higher score indicates a higher level of confidence.
4. Conviction to change will be measured using the Questionnaire of Health Belief second subscale. This is a 4-item questionnaire which uses a 5-point Likert scale to measure the perception of benefits to change. A higher score indicates fewer benefits.
5. Acceptability of the intervention will be measured using the Treatment Acceptability and Preference Questionnaire. This is a 4-item questionnaire which uses a 5-point Likert scale to measure the patients' opinion of the acceptability of a treatment. A higher score indicates greater acceptability of the treatment. An overall satisfaction question is also asked.
6. Feasibility of the intervention will be assessed by documenting the number of patients who:
6.1 Are eligible
6.2. Agree to participate in the study
6.3. Remain in the study one month after randomisation
7. Progression through the stages of change will be assessed using the evaluation made by the research nurse following each contact. At the beginning of each contact, the nurse will use an algorithm to determine the patient's stage of change. We will give a score of 1 to patients who progress to a higher stage over the course of the three contacts, and a score of 0 to patients who did not progress.

Overall trial start date

24/11/2008

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Hospitalised at the time of enrolment
2. Final discharge from the heart failure clinic (i.e. no more follow-up)

Recruitment start date

24/11/2008

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Canada

Trial participating centre

R -1520
Montreal
H1T 1C8
Canada

Sponsor information

Organisation

Montreal Heart Institute (Institut de cardiologie de Montréal) (Canada)

Sponsor details

c/o Louise Longpré
R-1520
Montreal Heart Institute Research Center
5000 Bélanger
Montreal
H1T 1C8
Canada
+1 514 376 3330
richard.maheu@icm-mhi.org

Sponsor type

Research organisation

Website

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

Funders

Funder type

Research organisation

Funder name

Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Education, Leisure and Sport (Ministère de l’éducation, loisirs et sport [MELS]) (Canada)

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20168193

Publication citations

  1. Results

    Paradis V, Cossette S, Frasure-Smith N, Heppell S, Guertin MC, The efficacy of a motivational nursing intervention based on the stages of change on self-care in heart failure patients., J Cardiovasc Nurs, 25, 2, 130-141, doi: 10.1097/JCN.0b013e3181c52497.

Additional files

Editorial Notes