Adaptive web-based stress management programs among adults with a cardiovascular disease: A pilot Sequential Multiple Assignment Randomized Trial (SMART).

OBJECTIVE: To assess the feasibility and acceptability of using a Sequential Multiple Assignment Randomized Trial (SMART) to optimize the delivery of a web-based, stress management intervention for patients with a cardiovascular disease (CVD). METHODS: 59 patients with a CVD and moderate stress were randomized to a self-directed web-based stress management program (n = 30) or the same intervention plus lay telephone coaching (n = 29). After 6 weeks, non-responders were re-randomized to continue with their initial intervention or switched to motivational interviewing (MI). Feasibility, acceptability, and clinical significance were assessed. RESULTS: SMART procedures were feasible. Attrition rates were almost twice as high in the web-only group than the lay coach group. This might be because of the low satisfaction (47%) in the web-only group. On average, 1.7/5 modules were completed. Effect sizes for stress and quality of life generally exceeded 0.2 (clinical benchmark), except for the group that initially received lay coaching and then switched to MI. CONCLUSIONS: Results suggest that a larger trial would be feasible. Issues pertaining to attrition and satisfaction for non-responders need to be addressed. PRACTICE IMPLICATIONS: Findings contribute to the evidence on how best to develop and deliver e-Health interventions to maximize their efficacy while remaining cost-effective.

A web-based tailored nursing intervention (TAVIE en m@rche) aimed at increasing walking after an acute coronary syndrome: Multicentre randomized trial.

AIM: Evaluate a web-based tailored nursing intervention, TAVIE en m@rche, on increasing daily steps after an acute coronary syndrome. DESIGN: Parallel two-group multicentre randomized trial. METHODS: An experimental group receiving TAVIE en m@rche, was compared to  a control group receiving hyperlinks to public websites. Acute coronary syndrome patients who were insufficiently active were recruited from three coronary care units. Daily steps at 12 weeks were the primary outcome. Secondary outcomes included self-reported walking and moderate to vigorous physical activity (MVPA). Exploratory outcomes were angina frequency, emergency department visits, hospitalizations and secondary prevention programme attendance. RESULTS: Primary data were analysed for 39 participants. No significant effects were found. At 12 weeks 275.9 more daily steps and 1,464.3 more energy expenditure in MVPA were found in the experimental group relative to the control. No effects were found for angina frequency, emergency department visits, hospitalizations and secondary prevention programme attendance. CONCLUSION: The lack of effect on our primary result may be explained by the intervention goal that was mismatched to the needs of our mostly sufficiently active sample at randomization, resulting in no meaningful change in daily steps. Although the non-significantly greater increase in self-reported MVPA may represent gains in health among the participants that accessed TAVIE en m@rche, this result should be interpreted with caution. IMPACT: From 40%-60% of acute coronary syndrome patients self-report insufficient levels of physical activity. No effect was found on the primary outcome of daily steps. Although not significant, a greater increase in MVPA was found at 12 weeks. The primary outcome can be explained by most of the sample having attained the physical activity recommendation at randomization. Caution in interpreting the non-significant increase in MVPA is warranted due to attrition bias and statistical uncertainty. Future directions may consider the timing of randomization in relation to meeting the needs of insufficiently active acute coronary syndrome patients.

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.

BACKGROUND: Despite the health benefits of increasing physical activity in the secondary prevention of acute coronary syndrome (ACS), up to 60% of ACS patients are insufficiently active. Evidence supporting the effect of Web-based interventions on increasing physical activity outcomes in ACS patients is growing. However, randomized controlled trials (RCTs) using Web-based technologies that measured objective physical activity outcomes are sparse. OBJECTIVE: Our aim is to evaluate in insufficiently active ACS patients, the effect of a fully automated, Web-based tailored nursing intervention (TAVIE en m@rche) on increasing steps per day. METHODS: A parallel two-group multicenter RCT (target N=148) is being conducted in four major teaching hospitals in Montréal, Canada. An experimental group receiving the 4-week TAVIE en m@rche intervention plus a brief "booster" at 8 weeks, is compared with the control group receiving hyperlinks to publicly available websites. TAVIE en m@rche is based on the Strengths-Based Nursing Care orientation to nursing practice and the Self-Determination Theory of human motivation. The intervention is centered on videos of a nurse who delivers the content tailored to baseline levels of self-reported autonomous motivation, perceived competence, and walking behavior. Participants are recruited in hospital and are eligible if they report access to a computer and report less than recommended physical activity levels 6 months before hospitalization. Most outcome data are collected online at baseline, and 5 and 12 weeks postrandomization. The primary outcome is change in accelerometer-measured steps per day between randomization and 12 weeks. The secondary outcomes include change in steps per day between randomization and 5 weeks, and change in self-reported energy expenditure for walking and moderate to vigorous physical activity between randomization, and 5 and 12 weeks. Theoretical outcomes are the mediating role of self-reported perceived autonomy support, autonomous and controlled motivations, perceived competence, and barrier self-efficacy on steps per day. Clinical outcomes are quality of life, smoking, medication adherence, secondary prevention program attendance, health care utilization, and angina frequency. The potential moderating role of sex will also be explored. Analysis of covariance models will be used with covariates such as sex, age, fatigue, and depression symptoms. Allocation sequence is concealed, and blinding will be implemented during data analysis. RESULTS: Recruitment started March 30, 2016. Data analysis is planned for November 2017. CONCLUSIONS: Finding alternative interventions aimed at increasing the adoption of health behavior changes such as physical activity in the secondary prevention of ACS is clearly needed. Our RCT is expected to help support the potential efficacy of a fully automated, Web-based tailored nursing intervention on the objective outcome of steps per day in an ACS population. If this RCT is successful, and after its implementation as part of usual care, TAVIE en m@rche could help improve the health of ACS patients at large. TRIAL REGISTRATION: ClinicalTrials.gov NCT02617641; https://clinicaltrials.gov/ct2/show/NCT02617641 (Archived by WebCite at http://www.webcitation.org/6pNNGndRa).

A pilot randomized trial of a smoking cessation nursing intervention in cardiac patients after hospital discharge.

BACKGROUND: One fifth of Canadians are smokers despite the availability of community-based smoking cessation programs. It was hypothesized that offering a post-discharge smoking cessation program to cardiac patients would decrease smoking rates at six months. METHOD: This pilot randomized study explored the feasibility, acceptability and preliminary efficacy of a smoking cessation intervention delivered by a smoking cessation nurse specialist (SCNS) to cardiac patients after hospital discharge. SAMPLE: Participants (N=40) were randomized to either a postdischarge telephone intervention delivered weekly for the first month and then monthly until the third month (experimental group [EG]), or referral to usual community care (control group [CG]). FINDINGS: The researchers confirmed the feasibility of recruitment and acceptability of the intervention, but dfficulty with follow-up. The intention-to-treat analysis showed similar smoking cessation rates in both groups at six months (25% EG versus 30% CG; p = 0.72). CONCLUSION: An intensifed follow-up protocol, or a more intensive, comprehensive and multidisciplinary intervention might be required, given the characteristics of the smokers.