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| Name | Class |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) | OTHER |
| Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | OTHER |
| Maisonneuve-Rosemont Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVIEenM@RCHE intervention | Experimental | The experimental group will receive a web-based tailored nursing intervention. Between 3 and 4 sessions of 15 to 25 minutes each are completed within 4 weeks. A booster session is delivered at 8 weeks post randomization. |
|
| Publicly available websites | Active Comparator | The control group will receive hyperlinks to four publicly available websites and one online booklet on the topic of walking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVIEenM@RCHE | Behavioral | The intervention goal is to increase up to 150 minutes per week of moderate-intensity physical activity through walking. The intervention is underpinned by Strengths-Based Nursing Care that specifies nursing values, and by Self-Determination Theory that specifies variables to tailor the intervention. The four intervention strategies are: 1) Providing information and feedback, 2) Exploring reasons to build motivation, 3) Exploring strengths to build confidence (self-efficacy), and 4) Developing an action plan to maintain motivation and confidence (self-efficacy). The TAVIE system platform is designed to provide a fully automated, easy to navigate website, and the main mode of delivery is video clips of a 'virtual nurse' who presents the tailored intervention content. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in accelerometer measured steps per day | Baseline, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in accelerometer measured steps per day | Baseline, and 5 weeks | |
| Change in self-reported energy expenditure in walking | Baseline, 5 weeks, and 12 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported perceived autonomy support | 5 weeks | |
| Change in self-reported controlled motivation | Baseline, and 5 weeks | |
| Change in self-reported autonomous motivation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Cossette, Ph.D. | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Insitute | Montreal | Quebec | H1P 2G7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24279721 | Background | 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. | |
| 28450272 | Background | 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. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Publicly available websites | Behavioral |
|
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| Change in self-reported energy expenditure in moderate to vigorous physical activity |
| Baseline, 5 weeks, and 12 weeks |
| Baseline, and 5 weeks |
| Change in self-reported perceived competence | Baseline, and 5 weeks |
| Change in self-reported barrier self-efficacy | Baseline, and 5 weeks |
| Self-reported global quality of life | 12 weeks |
| Self-reported emotional quality of life | 12 weeks |
| Self-reported physical quality of life | 12 weeks |
| Self-reported social quality of life | 12 weeks |
| Self-reported smoking abstinence | 12 weeks |
| Self-reported optimal medication use | 12 weeks |
| Self-reported uptake in a secondary prevention program | 12 weeks |
| Emergency department visits identified by medical chart review | 12 weeks |
| Hospitalizations identified by medical chart review | 12 weeks |
| Self-reported angina frequency | 12 weeks |
| D001519 |
| Behavior |