Motivational nursing intervention on treatment adherence in heart failure patients

ISRCTN ISRCTN71548370
DOI https://doi.org/10.1186/ISRCTN71548370
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sylvie Cossette
Scientific

R -1520
Montreal Heart Institute Research Center
5000 Bélanger est
Montreal
H1T 1C8
Canada

Phone +1 514 376 3330 ext 4012
Email sylvie.cossette.inf@umontreal.ca

Study information

Study designRandomised controlled trial, single centre
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe 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]
Study acronymPROJET MSSC
Study objectivesWe 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) studiedTreatment adherence/self-care behaviour in heart failure patients
InterventionThe 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 typeOther
Primary outcome measureSelf-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 measuresThe 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 study start date24/11/2008
Completion date01/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. 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 criteria1. Hospitalised at the time of enrolment
2. Final discharge from the heart failure clinic (i.e. no more follow-up)
Date of first enrolment24/11/2008
Date of final enrolment01/04/2009

Locations

Countries of recruitment

  • Canada

Study participating centre

R -1520
Montreal
H1T 1C8
Canada

Sponsor information

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

c/o Louise Longpré
R-1520
Montreal Heart Institute Research Center
5000 Bélanger
Montreal
H1T 1C8
Canada

Phone +1 514 376 3330
Email richard.maheu@icm-mhi.org
Website http://www.icm-mhi.org/en/index.html
ROR logo "ROR" https://ror.org/03vs03g62

Funders

Funder type

Research organisation

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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