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

NCT ID: NCT02411188

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-10-31

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.

Detailed Description

Cardiac rehabilitation programs (CRPs) have been shown to improve outcomes following a cardiac event. Referrals to the CRP are a standard part of the community-based continuing care process within the Winnipeg region, to include automatic referrals for hospitalized patients, based on specific criteria, physician referrals and self-referrals. However, fewer women than men are referred to and participate in CRPs in Winnipeg.

The investigators' study is unique in that the investigators plan to capture those women who may not be ready to change or participate in a traditional CRP. While women who are in the pre-contemplative or contemplative stages of change may not be ready to participate in a standard CRP, they may be willing to explore a complementary opportunity: the FHHS STEP Program. The overall goal of this project is to provide a collaborative team environment that will engage women; educate, and empower women; and provide women with the necessary personal resources to enable them to take the step towards a cardiac rehabilitation program and a life-long commitment to heart health. The investigators' 2-group randomized clinical trial will compare physiological and psychosocial outcomes among women completing a 12-week gender specific introduction to cardiac rehabilitation with non-program attenders.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STEP Program Group

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

Group Type: EXPERIMENTAL

The STEP Program

Intervention Type: 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

Usual Care Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The STEP Program

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Victoria General Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

Reh-Fit Fitness Centre

UNKNOWN

Sponsor Role: collaborator

Wellness Institute-Seven Oaks General Hospital

UNKNOWN

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo-Ann V Sawatzky, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Other Identifiers

UManitoba

Identifier Type: -

Identifier Source: org_study_id