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

Not Applicable

Withdrawn

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: The STEP Program

• Registration Number: NCT02411188
• Lead Sponsor: University of Manitoba

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Status Verified: 2015-11
• Study Start: 2016-02
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-02
• Primary Completion: 2018-03
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEP Program Group	The STEP Program	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

Primary Outcome Measures

Name	Time	Method
Cardiac Rehabilitation Program Enrolment	12 months	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

Secondary Outcome Measures

Name	Time	Method
Short-Form-36	baseline, 3, 6 and 12 months	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
Brief Symptom Inventory	baseline, 3, 6 and 12 months	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.
General Self-Efficacy Scale	baseline, 3, 6, 12 months	10 items; scoring based on 4-point Likert scale (1-4), with higher scores reflecting higher perceived self-efficacy
Multidimensional Self-Efficacy for Exercise Scale	baseline, 3, 6 and 12 months	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
Enhancing Recovery in Coronary Heart Disease Social Support Instrument	baseline, 3, 6 and 12 months	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
Stages of Change Questionnaire	baseline, 3, 6 and 12 months	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).
Health Resource Utilization Questionnaire	3, 6 and 12 months	4-items: self-reported number of contacts/visits with primary care provider, cardiologist, emergency department/Walk-in Clinic visits and hospital admissions.
International Physical Activity Questionnaire	baseline, 3, 6 and 12 months	9-item, subjective 7 day recall of physical activity patterns
Client Satisfaction Questionnaire	3 months	intervention group only; 8 items; 4-point Likert scale; assesses general satisfaction with the health care services received; higher scores reflect higher satisfaction
6-Minute Walk Test	baseline, 3, 6 and 12 months	total distanced walked in 6 minutes
Accelerometry	baseline, 3, 6 and 12 months	accelerometers monitor/measure physical activity/sedentary behaviours for a specified period of time (7 days).