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

For Her Heart's Sake: A Clinical Trial to Assess Strategies to Enhance Participation in Cardiac Rehabilitation - STEP Project

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: The STEP Program

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-Form-36	36 items re 8 dimensions: physical functioning (10 items), role limitations - physical (4 items), bodily pain (2 items), social functioning (2 items), general mental health (5 items), role limitations - emotional (3 items), vitality (4 items), general health perceptions, 5 items); coded to 0-100 score, with higher values representing more favourable states	baseline, 3, 6 and 12 months
Brief Symptom Inventory	53 items; 5-point Likert scale (1-5); operationalizes concepts of anxiety, depression and hostility; 9 symptom domains, with higher scores indicating greater levels of distress.	baseline, 3, 6 and 12 months
General Self-Efficacy Scale	10 items; scoring based on 4-point Likert scale (1-4), with higher scores reflecting higher perceived self-efficacy	baseline, 3, 6, 12 months
Multidimensional Self-Efficacy for Exercise Scale	9 items; 11-point Likert scale (0-10), with higher scores reflecting higher task efficacy (3 items), coping efficacy (3 items) and scheduling efficacy (3 items	baseline, 3, 6 and 12 months
Enhancing Recovery in Coronary Heart Disease Social Support Instrument	7 item scale is scored by totalling the six 5-point Likert scale items and a 7th item, which is scored 4 for 'yes' and 2 for 'no'. The scale captures structural, emotional and instrumental support	baseline, 3, 6 and 12 months
Stages of Change Questionnaire	12 5-point-Likert scale (1-5) questions; Stages of readiness to change for each of the listed behaviors include 5 response items representing each of the stages of change (i.e., precontemplation, contemplation, preparation, action, and maintenance).	baseline, 3, 6 and 12 months
Health Resource Utilization Questionnaire	4-items: self-reported number of contacts/visits with primary care provider, cardiologist, emergency department/Walk-in Clinic visits and hospital admissions.	3, 6 and 12 months
International Physical Activity Questionnaire	9-item, subjective 7 day recall of physical activity patterns	baseline, 3, 6 and 12 months
Client Satisfaction Questionnaire	intervention group only; 8 items; 4-point Likert scale; assesses general satisfaction with the health care services received; higher scores reflect higher satisfaction	3 months
6-Minute Walk Test	total distanced walked in 6 minutes	baseline, 3, 6 and 12 months
Accelerometry	accelerometers monitor/measure physical activity/sedentary behaviours for a specified period of time (7 days).	baseline, 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Victoria General Hospital Foundation; Reh-Fit Fitness Centre; Wellness Institute-Seven Oaks General Hospital
• Investigators: Principal Investigator: Jo-Ann V Sawatzky, RN, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: UManitoba