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Cardiovascular DiseasesFHHS: STEPNCT02411188

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

A study testing The STEP Program in people with Cardiovascular Diseases, run by University of Manitoba.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
The STEP Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Feb 2016to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

About this study

Official title: 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.

Read the 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.

Being tested
The STEP Program
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The STEP ProgramBehavioural

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

Study groups in NCT02411188
Study groupRoleWhat they receive
STEP Program GroupExperimentalArm: 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
Receives: Behavioral: The STEP Program
Usual Care GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (11)

  1. 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

    Measured: baseline, 3, 6 and 12 months

  2. 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.

    Measured: baseline, 3, 6 and 12 months

  3. General Self-Efficacy Scale

    10 items; scoring based on 4-point Likert scale (1-4), with higher scores reflecting higher perceived self-efficacy

    Measured: baseline, 3, 6, 12 months

  4. 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

    Measured: baseline, 3, 6 and 12 months

  5. 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

    Measured: baseline, 3, 6 and 12 months

  6. 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).

    Measured: baseline, 3, 6 and 12 months

  7. 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.

    Measured: 3, 6 and 12 months

  8. International Physical Activity Questionnaire

    9-item, subjective 7 day recall of physical activity patterns

    Measured: baseline, 3, 6 and 12 months

  9. 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

    Measured: 3 months

  10. 6-Minute Walk Test

    total distanced walked in 6 minutes

    Measured: baseline, 3, 6 and 12 months

  11. Accelerometry

    accelerometers monitor/measure physical activity/sedentary behaviours for a specified period of time (7 days).

    Measured: baseline, 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionMar 2018 (estimated)
  4. Study completionOct 2018 (estimated)

Why it stopped: recruitment issues; changed protocol to prospective cohort study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02411188
Sponsor's protocol ID
UManitoba
Acronym
FHHS: STEP
Status last verified
Nov 2015
First submitted
30 Mar 2015
Last updated
2 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing The STEP Program in people with Cardiovascular Diseases, run by University of Manitoba.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Rehabilitation Program Enrolment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02411188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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