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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.

ABSTRACT: 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).

SUBMITTER: Kayser JW

PROVIDER: S-EPMC5427251 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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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.

Kayser John William JW Cossette Sylvie S Côté José J Bourbonnais Anne A Purden Margaret M Juneau Martin M Tanguay Jean-Francois JF Simard Marie-Josée MJ Dupuis Jocelyn J Diodati Jean G JG Tremblay Jean-Francois JF Maheu-Cadotte Marc-André MA Cournoyer Daniel D

JMIR research protocols 20170427 4

<h4>Background</h4>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.<h4>Objective</h4>Our aim is to evaluate in ...[more]

PMID: 28450272

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Project description:Preconception care may be an efficacious tool to reduce risk factors for adverse pregnancy outcomes that are associated with lifestyles and health status before pregnancy. We conducted a web-based cohort study in Italian women planning a pregnancy to assess whether a tailored web intervention may change knowledge and behaviours associated with risks for adverse pregnancy outcomes.The study was entirely conducted on the web on a cohort of Italian women of childbearing age. Data collected at baseline on health status, lifestyles and knowledge of risk factors for adverse pregnancy outcomes were used for generating a tailored document including recommendations for folic acid supplementation, obesity and underweight, smoking, alcohol consumption, vaccinations, chronic and genetic diseases, exposure to medications. Prevalence of risk factors and knowledge was assessed 6 months after the intervention. Logistic regression models were used to explore the factors associated with risk factors after the intervention.Of the 508 enrolled women, 282 (55.5%) completed the study after 6 months since the delivery of tailored recommendations. At baseline, 48% of the participants took folic acid supplementation (95% CI 43.2; 51.9) and 69% consumed alcohol (95% CI 64.7; 72.9). At the follow up 71% of the participants had a preconception visit with a physician. Moreover we observed a decrease of alcohol consumption (-46.5% 95% CI -53.28; -38.75) and of the proportion of women not taking folic acid supplementation (-23.4% 95% CI -31.0; 15.36). We observed an improvement in knowledge of the information about the preconception behaviours to prevent adverse pregnancy outcomes (20.9% 95% CI 14.6%; 27.1%). Having a preconception visit during follow up was significally associated to an increase in folic acid supplementation (OR 2.53 95% CI 1.40; 4.60).Our results suggest that a tailored web intervention may improve general preconception health in women planning a pregnancy. A web preconception intervention may be integrated with classic preconception care by health professionals. Clinical trials should be conducted to confirm these findings.

Project description:BackgroundIllness management after an acute coronary syndrome (ACS) is crucial to prevent cardiac complications, to foster participation in a cardiac rehabilitation (CR) program, and to optimize recovery. Web-based tailored interventions have the potential to provide individualized information and counseling to optimize patient's illness management after hospital discharge.ObjectiveWe aimed to assess the feasibility and acceptability of a Web-based tailored intervention (TAVIE@COEUR) designed to improve illness management in patients hospitalized for an ACS. Illness management outcomes were operationalized by self-care, medication adherence, anxiety management, cardiac risk factors reduction, and enrollment in a CR program.MethodsThis posttest pilot study was conducted with one group (N=30) of patients hospitalized for an ACS on the coronary care unit of a tertiary cardiology center. TAVIE@COEUR comprises three Web-based sessions, with a duration ranging from 10 to 45 min and is structured around an algorithm to allow the tailoring of the intervention to different pathways according to patients' responses to questions. TAVIE@COEUR includes 90 pages, 85 videos, and 47 PDF documents divided across session 1 (S1), session 2 (S2), and session 3 (S3). These sessions concern self-care and self-observation skills related to medication-taking (S1), emotional control and problem-solving skills (S2), and social skills and interacting with health professionals (S3). Throughout the videos, a virtual nurse (providing the intervention virtually) guides the participants in the acquisition of self-care skills. Patients completed S1 of TAVIE@COEUR before hospital discharge and were asked to complete S2 and S3 within 2 weeks after discharge. Feasibility indicators were extracted from the TAVIE@COEUR system. Data regarding acceptability (satisfaction and appreciation of the platform) and preliminary effect (self-care, medication adherence, anxiety management, risk factor reduction, and CR enrollment) were assessed through questionnaires at 1 month following discharge. Preliminary effect was assessed by comparing baseline and 1-month illness management variables.ResultsOf the 30 participants, 20 completed S1, 10 completed S2, and 5 completed S3. Good acceptability scores were observed for ease of navigation (mean=3.58, standard deviation [SD]=0.70; scale=0-4), ease of understanding (mean=3.46, SD=0.63; scale=0-4), and applicability (mean=3.55, SD=0.74; scale=0-4). The lowest acceptability scores were observed for information tailoring (mean=2.93, SD=0.68; scale=0-4) and individual relevance (mean=2.56, SD=0.96; scale=0-4). With regard to preliminary effect, we observed an overall self-care at 1 month following discharge score higher than at baseline (mean at 1 month=54.07, SD=3.99 vs mean at baseline=49.09, SD=6.92; scale-0-60).ConclusionsAlthough participants reported general satisfaction and appreciation of TAVIE@COEUR, acceptability and feasibility results show the need for further development of the Web-based intervention to enhance its tailoring before undertaking a full-fledged randomized controlled trial. This may be accomplished by optimizing the adaptability of TAVIE@COEUR to patients' knowledge, needs, interests, individual capabilities, and emotional and cognitive responses during session completion.

Project description:BackgroundDespite decades of nutrition education, the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist. Therefore, it is important to innovate and improve existing nutrition education interventions. This paper describes the development, design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit, vegetable, high-energy snack and fat intake. This intervention innovates existing computer-tailored interventions by not only targeting motivational factors, but also volitional and self-regulation processes and environmental-level factors.Methods/designThe intervention development was guided by the Intervention Mapping protocol, ensuring a theory-informed and evidence-based intervention. Two versions of the intervention were developed: a basic version targeting knowledge, awareness, attitude, self-efficacy and volitional and self-regulation processes, and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets. Both versions consist of four modules: one for each dietary behavior, i.e. fruit, vegetables, high-energy snacks and fat. Based on the self-regulation phases, each module is divided into three sessions. In the first session, feedback on dietary behavior is provided to increase awareness, feedback on attitude and self-efficacy is provided and goals and action plans are stated. In the second session goal achievement is evaluated, reasons for failure are explored, coping plans are stated and goals can be adapted. In the third session, participants can again evaluate their behavioral change and tips for maintenance are provided. Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline, 1-month, 4-months and 9-months post-intervention, using online questionnaires. Both versions will be compared with a generic nutrition information control condition. The primary outcomes are fruit, vegetable, high-energy snack and fat intake.DiscussionThe evaluation study will provide insight into the short- and long-term efficacy of both intervention versions in adults. Additionally, differences in the efficacy among high- and low-educated people will be examined. If these interventions are effective, two well-developed interventions will become available for the implementation and promotion of healthy dietary patterns among both high- and low-educated adults in the Netherlands.Trial registrationDutch Trial Registry NTR3396.

Project description:Long-term use of antiretroviral therapy, normal aging, and presence of certain risk factors are associated with metabolic disorders that predispose persons living with HIV to diabetes and cardiovascular diseases. The emergence and progression of these disorders can be prevented by adopting healthy behaviours. Based on the theory of planned behaviour, the Web-based tailored intervention TAVIE en santé was developed. The aim of this study is to evaluate the effectiveness of TAVIE en santé in order to support people living with HIV in the adoption of health promoting behaviours.An online randomized controlled trial with parallel-groups will be conducted across Canada. To participate in this study, people living with HIV must be: ? 18 years, able to read/understand French or English, have access to the Internet. A convenience sample of 750 participants will be randomly assigned either to an experimental group (TAVIE en santé, n?=?375) or to a control group (websites, n?=?375) (1:1 allocation ratio). The TAVIE en santé intervention is composed of seven interactive computer sessions, lasting between 5 and 10 min. The sessions, hosted by a virtual nurse, aim to develop and strengthen skills required for behaviour change. The control group will receive a validated list of five predetermined conventional health-related Websites. The adoption of health behaviour (smoking cessation or physical activity or healthy eating) is the principal outcome. Cognitions (intention, attitude, perceived behavioral control) are the secondary outcomes. Health indicators will also be assessed. All outcomes will be measured with a self-administered online questionnaire and collected three times: at baseline, 3 and 6 months after. The principal analyses will focus on differences between the two trial groups using Intention-to-Treat analysis.This study will yield new results about the efficacy of Web-based tailored health behaviours change interventions in the context of chronic disease. The TAVIE en santé intervention could constitute an accessible complementary service in support of existing specialized services to support people living with HIV adopt health behaviors.NCT02378766 , assigned on March 3th 2015.

Project description:Background: Currently, the eHealth field calls for detailed descriptions of theory-based interventions in order to support improved design of such interventions. This article aims to provide a systematic description of the design rationale behind an interactive web-based tailored intervention promoting HPV-vaccination acceptability. Methods: The 6-step Intervention Mapping (IM) protocol was used to describe the design rationale. After the needs assessment in Step 1, intervention objectives were formulated in Step 2. In Step 3, we translated theoretical methods into practical applications, which were integrated into a coherent intervention in Step 4. In Step 5, we anticipated future implementation and adoption, and finally, an evaluation plan was generated in Step 6. Results: Walking through the various steps of IM resulted in a detailed description of the intervention. The needs assessment indicated HPV-vaccination uptake remaining lower than expected. Mothers play the most important role in decision-making about their daughter's immunization. However, they generally feel ambivalent after they made their decisions, and their decisions are based on rather unstable grounds. Therefore, intervention objectives were to improve HPV-vaccination uptake and informed decision-making, and to decrease decisional conflict among mothers of invited girls. Computer-tailoring was chosen as the main method; virtual assistants were chosen as a practical application to deliver interactive tailored feedback. To maximize compatibility with the needs of the target group, a user-centered design strategy by means of focus groups and online experiments was applied. In these, prototypes were tested and sequentially refined. Finally, efficacy, effectiveness, and acceptability of the intervention were tested in a randomized controlled trial. Results showed a significant positive effect of the intervention on informed decision-making, decisional conflict, and nearly all determinants of HPV-vaccination uptake (P < 0.001). Mothers evaluated the intervention as highly positive. Discussion: Using IM led to an innovative effective intervention for promoting HPV-vaccination acceptability. The intervention maps will aid in interpreting the results of our evaluation studies. Moreover, it will ease the comparison of design rationales across interventions, and may provide leads for the development of other eHealth interventions. This paper adds to the plea for systematic reporting of design rationales constituting the process of developing interventions.

Project description:BackgroundPhysical inactivity in people with chronic stroke profoundly affects daily function and increases recurrent stroke risk and mortality, making physical activity improvements an important target of intervention. We compared the effects of a highintensity walking intervention (FAST), a step activity monitoring behavioral intervention (SAM), or a combined intervention (FAST+SAM) on physical activity (i.e., steps per day). We hypothesized the combined intervention would yield the greatest increase in steps per day.MethodsThis assessor-blinded multi-site randomized controlled trial was conducted at four university/hospital-based laboratories. Participants were 21-85 years old, walking without physical assistance following a single, unilateral non-cerebellar stroke of ≥6 months duration, and randomly assigned to FAST, SAM, or FAST+SAM for 12 weeks (2-3 sessions/week). FAST training consisted of walking-related activities for 40 minutes/session at 70-80% heart rate reserve, while SAM received daily feedback and goal-setting of walking activity (steps per day). Assessors and study statistician were masked to group assignment.The a priori-determined primary outcome and primary endpoint was change in steps per day from pre- to post-intervention. Adverse events (AEs) were tracked after randomization. All randomized participants were included in the intent-to-treat analysis.This study is registered at ClinicalTrials.gov, NCT02835313.FindingsParticipants were enrolled from July 18, 2016-November 16, 2021. Of 250 randomized participants (mean[SE] age 63[0.80], 116F/134M), 89 were assigned to FAST, 81 to SAM, and 80 to FAST+SAM. Steps per day significantly increased in both the SAM (mean[SE] 1542[267], 95%CI:1014-2069, p<0.001) and FAST+SAM groups (1307[280], 752-1861, p<0.001), but not in the FAST group (406[238], 63-876, p=0.09). There were no deaths or serious study-related AEs and all other minor AEs were similar between groups.InterpretationOnly individuals with chronic stroke who completed a step activity monitoring behavioral intervention with skilled coaching and goal progression demonstrated improvements in physical activity (steps per day).

Dataset Information

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.

Publications

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.

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