Clinical trial NCT02411188: For Her Heart's Sake STEP Project: A Clinical Trial
Official title: For Her Heart's Sake: A Clinical Trial to Assess Strategies to Enhance Participation in Cardiac Rehabilitation - STEP Project
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Victoria General Hospital Foundation
name: Reh-Fit Fitness Centre
name: Wellness Institute-Seven Oaks General Hospital
First posted: 2015-04-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Cardiac Rehabilitation Program Enrolment
timeFrame: 12 months
Secondary outcomes:
measure: Short-Form-36
timeFrame: baseline, 3, 6 and 12 months
measure: Brief Symptom Inventory
timeFrame: baseline, 3, 6 and 12 months
measure: General Self-Efficacy Scale
timeFrame: baseline, 3, 6, 12 months
measure: Multidimensional Self-Efficacy for Exercise Scale
timeFrame: baseline, 3, 6 and 12 months
measure: Enhancing Recovery in Coronary Heart Disease Social Support Instrument
timeFrame: baseline, 3, 6 and 12 months
measure: Stages of Change Questionnaire
timeFrame: baseline, 3, 6 and 12 months
measure: Health Resource Utilization Questionnaire
timeFrame: 3, 6 and 12 months
measure: International Physical Activity Questionnaire
timeFrame: baseline, 3, 6 and 12 months
measure: Client Satisfaction Questionnaire
timeFrame: 3 months
measure: 6-Minute Walk Test
timeFrame: baseline, 3, 6 and 12 months
measure: Accelerometry
timeFrame: baseline, 3, 6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Jo-Ann V Sawatzky, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: