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 design	Randomised controlled trial, single centre
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	24/11/2008
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

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"	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 léducation, loisirs et sport [MELS]) (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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