Clinical trial NCT02617641: A Web-Based Tailored Nursing Intervention to Increase Walking in Patients After an Acute Coronary Syndrome
Official title: Evaluation of a Web-Based Tailored Nursing Intervention (TAVIEenM@RCHE) Aimed at Increasing Walking in Patients After an Acute Coronary Syndrome: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Secondary Prevention
Walking
Health Behavior
Internet
eHealth
Computer-Assisted Instruction
Multicenter Study
Randomized Controlled Trial
Intervention Studies
Motivation
Self Efficacy
Theory, Nursing
Theory, Psychological
Nursing Research
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Centre hospitalier de l'Université de Montréal (CHUM)
name: Hopital du Sacre-Coeur de Montreal
name: Maisonneuve-Rosemont Hospital
First posted: 2015-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Acute coronary syndromes (ACS) are one of the leading causes of coronary artery disease mortality, and among the top reasons for health care utilization in Canada. Physical activity counselling is a core component of secondary prevention interventions because increased physical activity is associated with reduced mortality risk, improved quality of life, reduced coronary risk factors, and reduced health care utilization. Despite these health benefits, between 40% and 60% of patients after an ACS event are insufficiently active. Web-based interventions offer innovative alternatives for intervention delivery via the Internet in secondary prevention. However, there is a paucity of randomized controlled trials testing, in ACS patients, computer-tailored interventions that include videos within the tailored algorithm. The purpose of this multicenter randomized controlled trial is to test a web-based intervention, TAVIEenM@RCHE, that uses tailored-videos of a nurse, the 'virtual nurse', aimed at increasing physical activity through walking in ACS patients.

Detailed description: After baseline data is collected, the participants (N = 148) will be randomized to either one of two groups: 1) access to the 4-week TAVIEenM@RCHE intervention with an additional "booster" at 8 weeks (experimental group) or 2) access to a list of publicly available websites (control group). Participants will be included if they report insufficient levels of physical activity prior hospitalization, and they have no serious medical conditions impeding adherence to moderate-intensity physical activity. Data collection will occur at recruitment (in-hospital), at baseline (home 3 weeks post-hospital discharge), and at 5 and 12 weeks post baseline. The data analysis will be consistent with intention-to-treat principles. Baseline characteristics will be compared using descriptive statistics to identify trends in group imbalances. For the analysis of the primary outcome of change in steps per day between baseline and 12 weeks, and the secondary outcome of change in steps per day between baseline and 5 weeks, a repeated measures ANCOVA model will compare the adjusted differences between the experimental and control groups at a significance of 0.05. For the analysis of the two secondary outcomes of change in energy expenditure in walking and in moderate-intensity physical activity between baseline and 5 weeks, and between baseline and 12 weeks, a repeated measures MANCOVA model will compare the adjusted differences between the experimental and control groups at a significance of 0.05.

Eligibility criteria: Inclusion Criteria:

1. Discharged 3 weeks home post ACS-related hospitalization.
2. No serious medical condition exists that would impede adhering to moderate-intensity physical activity. Medical conditions include, for instance, incapacitating chronic pain, paralysis, equilibrium problems, diabetic ulcers, fluid restrictions, dyspnea, home oxygen dependency, cancer and others. Also, no environmental restrictions that would impede walking.
3. Receives usual care follow-up post ACS-related hospitalization.
4. Reported access to any computer device that has a USB port and this computer is connected to the Internet to allow upload of data from the accelerometer, and has speaker or headphones to enable listening to the intervention on the computer device of choice.
5. Reported ability to read and speak French.

Exclusion Criteria:

1. Reported sufficient physical activity during 6 months prior to hospitalization: performed at least 150 minutes of moderate-intensity physical activity per week (30 minutes five days a week) or at least 75 minutes per week of vigorous-intensity physical activity (25 minutes three days a week).
2. Indicated in the medical chart or reported by staff, physical or psychological/cognitive that would make it impossible for the patient to provide informed consent.
3. Documented New York Heart Association Class III to IV heart failure.
4. Involved in other intensive regular clinical follow-up during TAVIEenM@RCHE.

Primary outcomes:
measure: Change in accelerometer measured steps per day
timeFrame: Baseline, and 12 weeks
Secondary outcomes:
measure: Change in accelerometer measured steps per day
timeFrame: Baseline, and 5 weeks
measure: Change in self-reported energy expenditure in walking
timeFrame: Baseline, 5 weeks, and 12 weeks
measure: Change in self-reported energy expenditure in moderate to vigorous physical activity
timeFrame: Baseline, 5 weeks, and 12 weeks
Other outcomes:
measure: Self-reported perceived autonomy support
timeFrame: 5 weeks
measure: Change in self-reported controlled motivation
timeFrame: Baseline, and 5 weeks
measure: Change in self-reported autonomous motivation
timeFrame: Baseline, and 5 weeks
measure: Change in self-reported perceived competence
timeFrame: Baseline, and 5 weeks
measure: Change in self-reported barrier self-efficacy
timeFrame: Baseline, and 5 weeks
measure: Self-reported global quality of life
timeFrame: 12 weeks
measure: Self-reported emotional quality of life
timeFrame: 12 weeks
measure: Self-reported physical quality of life
timeFrame: 12 weeks
measure: Self-reported social quality of life
timeFrame: 12 weeks
measure: Self-reported smoking abstinence
timeFrame: 12 weeks
measure: Self-reported optimal medication use
timeFrame: 12 weeks
measure: Self-reported uptake in a secondary prevention program
timeFrame: 12 weeks
measure: Emergency department visits identified by medical chart review
timeFrame: 12 weeks
measure: Hospitalizations identified by medical chart review
timeFrame: 12 weeks
measure: Self-reported angina frequency
timeFrame: 12 weeks
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Insitute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Sylvie Cossette, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kayser JW, Cossette S, Alderson M. Autonomy-supportive intervention: an evolutionary concept analysis. J Adv Nurs. 2014 Jun;70(6):1254-66. doi: 10.1111/jan.12292. Epub 2013 Nov 27.
citation: Kayser JW, Cossette S, Cote J, Bourbonnais A, Purden M, Juneau M, Tanguay JF, Simard MJ, Dupuis J, Diodati JG, Tremblay JF, Maheu-Cadotte MA, Cournoyer D. Evaluation of a Web-Based Tailored Nursing Intervention (TAVIE en m@rche) Aimed at Increasing Walking After an Acute Coronary Syndrome: A Multicenter Randomized Controlled Trial Protocol. JMIR Res Protoc. 2017 Apr 27;6(4):e64. doi: 10.2196/resprot.6430.