For Her Heart's Sake STEP Project: A Clinical Trial

NCT02411188 | Withdrawn

• 1 other identifier: UManitoba
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of the proposed project is to determine if providing an intervention for women who decline the invitation to participate in standard cardiac rehabilitation programs (CRPs) will ultimately result in an increase their participation in CRPs.This study will evaluate outcomes of patients randomized to the FHHS STEP Program versus by non-STEP Program participants. The overall goal is to provide an alternate, introductory program that will engage, educate, and empower women following a cardiac event. Providing these women with the necessary personal resources will encourage and enable these women to take the step towards a cardiac rehabilitation program, which, in turn will ideally lead to a life-long commitment to heart health.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Cardiac Rehabilitation Program Enrolment

  3 yes/no questions: have you contacted a CRP; have you joined a CRP; do you plan to contact a CRP. if not, why not

  12 months

Secondary Outcomes (11)

• Short-Form-36

  baseline, 3, 6 and 12 months

• Brief Symptom Inventory

  baseline, 3, 6 and 12 months

• General Self-Efficacy Scale

  baseline, 3, 6, 12 months

• Multidimensional Self-Efficacy for Exercise Scale

  baseline, 3, 6 and 12 months

• Enhancing Recovery in Coronary Heart Disease Social Support Instrument

  baseline, 3, 6 and 12 months

Study Arms (2)

STEP Program Group

EXPERIMENTAL

Arm: Intervention: The 12-week STEP Program intervention will include: initial individual consult/goal setting; weekly 90 minute information/interactive sessions; individualized patient centred care; journaling

Behavioral: The STEP Program

Usual Care Group

NO INTERVENTION

The usual care group will follow the routine model of care for post-discharge patients who do not participate in a CRP. Usual care group participants will be given the opportunity/option to participate in the STEP Program in 6 months.

Interventions

The STEP Program BEHAVIORAL

Intervention: The 12-week STEP Program will include: initial individual consult/goal setting; weekly 90 minute information/interactive sessions; individualized patient centred care; journaling

STEP Program Group

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Discharged from a Winnipeg Regional Health Authority (WRHA) facility;
• Diagnosis of stable ischemic heart disease or acute coronary syndrome who have undergone revascularization via coronary artery bypass graft (CABG) surgery or elective percutaneous coronary intervention (PCI);
• Diagnosis of valvular heart disease who have undergone valve surgery;
• Diagnosis of stable ischemic or non-ischemic heart failure;
• Able to read, write, and speak English;
• Referred to and declined participation in a CRP in Winnipeg;
• Willing and able to attend the STEP Program at the Victoria General Hospital.

You may not qualify if:

• Patients who have unstable or recent unstable cardiac syndrome, as defined by:
• Severe heart failure (New York Heart Association Class IV) or angina (Canadian Cardiovascular Society Class IV) symptoms
• Non-re-vascularized \> triple vessel disease
• Non-repaired severe valvular heart disease (aortic or mitral area \< 1.0cm2 or mean gradient \> 40 mmhg or \> 10mmHg \[millimetres of mercury\] respectively)
• Severe systolic heart failure (LVEF \[left ventricular ejection fraction\] \< 30%)
• High risk stress test
• Exercise induced ventricular arrhythmias or recent (within the past 6 months) hospitalization for ventricular arrhythmias
• Unstable arrhythmias (i.e., bradycardia; tachyarrhythmias)
• Previous attendance in a CRP
• Physical limitations that would preclude ability to walk
• Cognitive impairment/deficits that would preclude participation in the STEP Project
• Automatic internal cardiac defibrillator in situ
• On waitlist for cardiac procedure (e.g., cardiac surgery; PCI)

Sponsors & Collaborators

• University of Manitoba: lead
• Victoria General Hospital Foundation: collaborator
• Reh-Fit Fitness Centre: collaborator
• Wellness Institute-Seven Oaks General Hospital: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Jo-Ann V Sawatzky, RN, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 8, 2015
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 2, 2016

Record last verified: 2015-11