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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

TAVIEenM@RCHE

Publicly available websites

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Montreal Heart Insitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAVIEenM@RCHE intervention

Publicly available websites

Arm Description

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.

The control group will receive hyperlinks to four publicly available websites and one online booklet on the topic of walking.

Outcomes

Primary Outcome Measures

Change in accelerometer measured steps per day

Secondary Outcome Measures

Change in accelerometer measured steps per day

Change in self-reported energy expenditure in walking

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

Full Information

NCT ID

NCT02617641

First Posted

November 23, 2015

Last Updated

January 15, 2018

Sponsor

Montreal Heart Institute

Collaborators

Centre hospitalier de l'Université de Montréal (CHUM), Hopital du Sacre-Coeur de Montreal, Maisonneuve-Rosemont Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02617641

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

March 30, 2016 (Actual)

Primary Completion Date

October 29, 2017 (Actual)

Study Completion Date

October 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montreal Heart Institute

Collaborators

Centre hospitalier de l'Université de Montréal (CHUM), Hopital du Sacre-Coeur de Montreal, Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAVIEenM@RCHE intervention

Arm Type

Experimental

Arm Description

Arm Title

Publicly available websites

Arm Type

Active Comparator

Arm Description

The control group will receive hyperlinks to four publicly available websites and one online booklet on the topic of walking.

Intervention Type

Behavioral

Intervention Name(s)

TAVIEenM@RCHE

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Publicly available websites

Intervention Description

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 Outcome Measure Information:

Title

Change in accelerometer measured steps per day

Time Frame

Baseline, and 12 weeks

Secondary Outcome Measure Information:

Title

Change in accelerometer measured steps per day

Time Frame

Baseline, and 5 weeks

Title

Change in self-reported energy expenditure in walking

Time Frame

Baseline, 5 weeks, and 12 weeks

Title

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

Time Frame

Baseline, 5 weeks, and 12 weeks

Other Pre-specified Outcome Measures:

Title

Self-reported perceived autonomy support

Time Frame

5 weeks

Title

Change in self-reported controlled motivation

Time Frame

Baseline, and 5 weeks

Title

Change in self-reported autonomous motivation

Time Frame

Baseline, and 5 weeks

Title

Change in self-reported perceived competence

Time Frame

Baseline, and 5 weeks

Title

Change in self-reported barrier self-efficacy

Time Frame

Baseline, and 5 weeks

Title

Self-reported global quality of life

Time Frame

12 weeks

Title

Self-reported emotional quality of life

Time Frame

12 weeks

Title

Self-reported physical quality of life

Time Frame

12 weeks

Title

Self-reported social quality of life

Time Frame

12 weeks

Title

Self-reported smoking abstinence

Time Frame

12 weeks

Title

Self-reported optimal medication use

Time Frame

12 weeks

Title

Self-reported uptake in a secondary prevention program

Time Frame

12 weeks

Title

Emergency department visits identified by medical chart review

Time Frame

12 weeks

Title

Hospitalizations identified by medical chart review

Time Frame

12 weeks

Title

Self-reported angina frequency

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sylvie Cossette, Ph.D.

Organizational Affiliation

Montreal Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montreal Heart Insitute

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1P 2G7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24279721

Citation

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.

Results Reference

background

PubMed Identifier

28450272

Citation

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.

Results Reference

background

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

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