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Completed

NCT Number: NCT02617641

A Web-Based Tailored Nursing Intervention to Increase Walking in Patients After an Acute Coronary Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Insitute

Montreal, Quebec, H1P 2G7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Discharged 3 weeks home post ACS-related hospitalization.
  • 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.
  • Receives usual care follow-up post ACS-related hospitalization.
  • 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.
  • Reported ability to read and speak French.

Exclusion criteria

  • 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).
  • 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.
  • Documented New York Heart Association Class III to IV heart failure.
  • Involved in other intensive regular clinical follow-up during TAVIEenM@RCHE.

Treatment and study plan

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.

Publicly available websites

Behavioral
  • Le Programme de marche (Institut de Cardiologie de Montréal)
  • L'activité physique (Institut de Cardiologie de Montréal)
  • L'activité physique (Fondation des maladies du cœur et de l'AVC)
  • Directives canadiennes en matiére d'activité physique à l'intention des adultes âgés de 65 ans et plus (Société Canadienne de Physiologie de l'exercice)
  • Directives canadiennes en matière d'activité physique à l'intention des personnes âgées de 65 et plus (ParticipACTION)

Primary outcomes

  1. Change in accelerometer measured steps per day

    Time frame: Baseline, and 12 weeks

Secondary outcomes

  1. Change in accelerometer measured steps per day

    Time frame: Baseline, and 5 weeks

  2. Change in self-reported energy expenditure in walking

    Time frame: Baseline, 5 weeks, and 12 weeks

  3. Change in self-reported energy expenditure in moderate to vigorous physical activity

    Time frame: Baseline, 5 weeks, and 12 weeks

Other outcomes

  1. Self-reported perceived autonomy support

    Time frame: 5 weeks

  2. Change in self-reported controlled motivation

    Time frame: Baseline, and 5 weeks

  3. Change in self-reported autonomous motivation

    Time frame: Baseline, and 5 weeks

  4. Change in self-reported perceived competence

    Time frame: Baseline, and 5 weeks

  5. Change in self-reported barrier self-efficacy

    Time frame: Baseline, and 5 weeks

  6. Self-reported global quality of life

    Time frame: 12 weeks

  7. Self-reported emotional quality of life

    Time frame: 12 weeks

  8. Self-reported physical quality of life

    Time frame: 12 weeks

  9. Self-reported social quality of life

    Time frame: 12 weeks

  10. Self-reported smoking abstinence

    Time frame: 12 weeks

  11. Self-reported optimal medication use

    Time frame: 12 weeks

  12. Self-reported uptake in a secondary prevention program

    Time frame: 12 weeks

  13. Emergency department visits identified by medical chart review

    Time frame: 12 weeks

  14. Hospitalizations identified by medical chart review

    Time frame: 12 weeks

  15. Self-reported angina frequency

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
  • Centre hospitalier de l'Université de Montréal (CHUM)
  • Maisonneuve-Rosemont Hospital

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2015
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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