Acute Coronary SyndromeNCT02617641
A Web-Based Tailored Nursing Intervention to Increase Walking in Patients After an Acute Coronary Syndrome
A study testing TAVIEenM@RCHE and Publicly available websites in people with Acute Coronary Syndrome, run by Montreal Heart Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- TAVIEenM@RCHE and Publicly available websites
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2016to 29 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- TAVIEenM@RCHE, Publicly available websites
- 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
- Medical subject headings
- Acute Coronary Syndrome, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVIEenM@RCHEBehavioural
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 websitesBehavioural
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Publicly available websites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in accelerometer measured steps per day
Measured: Baseline, and 12 weeks
Secondary outcomes (3)
Change in accelerometer measured steps per day
Measured: Baseline, and 5 weeks
Change in self-reported energy expenditure in walking
Measured: Baseline, 5 weeks, and 12 weeks
Change in self-reported energy expenditure in moderate to vigorous physical activity
Measured: Baseline, 5 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start30 Mar 2016
- Primary completion29 Oct 2017
- Study completion29 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Maisonneuve-Rosemont Hospital
- Responsible party
- Principal investigator, Sylvie Cossette, Montreal Heart Institute
- Investigators
- Sylvie Cossette, Ph.D., Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617641
- Sponsor's protocol ID
- 2015-1887
- Status last verified
- Jan 2018
- First submitted
- 23 Nov 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24279721Kayser 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.
PubMed 28450272
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02617641
- Acronym / sponsor ID
- 2015-1887
- Conditions
- Acute Coronary Syndrome
- Keywords
- Secondary Prevention, Walking, Health Behavior, Internet, eHealth, Computer-Assisted Instruction, Multicenter Study, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM), Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Maisonneuve-Rosemont Hospital
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 29 Oct 2017 (actual)
- Study completion
- 29 Oct 2017 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVIEenM@RCHE intervention | Experimental | Behavioral: TAVIEenM@RCHEThe 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. |
| Publicly available websites | Active comparator | Behavioral: Publicly available websitesThe control group will receive hyperlinks to four publicly available websites and one online booklet on the topic of walking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVIEenM@RCHEThe 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. | Behavioural | TAVIEenM@RCHE intervention |
| Publicly available websites* 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) | Behavioural | Publicly available websites |
Primary outcome
Change in accelerometer measured steps per day
Time frame: Baseline, and 12 weeks
3 secondary outcomes
Change in accelerometer measured steps per day
Time frame: Baseline, and 5 weeks
Change in self-reported energy expenditure in walking
Time frame: Baseline, 5 weeks, and 12 weeks
Change in self-reported energy expenditure in moderate to vigorous physical activity
Time frame: Baseline, 5 weeks, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 24279721Kayser 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.
- Background: PubMed 28450272Kayser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Cossette, Ph.D. principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVIEenM@RCHE and Publicly available websites in people with Acute Coronary Syndrome, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in accelerometer measured steps per day (time frame: Baseline, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617641, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.