Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02617641
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2015-11-23
Brief Title:
A Web-Based Tailored Nursing Intervention to Increase Walking in Patients After an Acute Coronary Syndrome
Sponsor:
Montreal Heart Institute
Organization:
Montreal Heart Institute
Study Overview
Official Title:
Evaluation of a Web-Based Tailored Nursing Intervention TAVIEenMRCHE Aimed at Increasing Walking in Patients After an Acute Coronary Syndrome A Multicenter Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 TAVIEenMRCHE 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 TAVIEenMRCHE 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 005 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None