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

NCT02617641 | Completed

• 1 other identifier: 2015-1887
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in accelerometer measured steps per day

  Baseline, and 12 weeks

Secondary Outcomes (3)

• 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

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

  Baseline, 5 weeks, and 12 weeks

Other Outcomes (15)

• Self-reported perceived autonomy support

  5 weeks

• Change in self-reported controlled motivation

  Baseline, and 5 weeks

• Change in self-reported autonomous motivation

  Baseline, and 5 weeks

Study Arms (2)

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.

Behavioral: TAVIEenM@RCHE

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.

Behavioral: Publicly available websites

Interventions

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.

TAVIEenM@RCHE intervention

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)

Publicly available websites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Montreal Heart Insitute

Montreal, Quebec, H1P 2G7, Canada

Location

Related Publications (2)

• 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.

  PMID: 24279721 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.

  PMID: 28450272 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Health Behavior

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Study Officials

• Sylvie Cossette, Ph.D.

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: March 30, 2016
• Primary Completion: October 29, 2017
• Study Completion: October 29, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

CA (1)