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Integrated Disease Management for Heart Failure

N/A

Waitlist Available

Led By Christopher Licskai

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HF or cardiovascular related hospitalization and/or ED visit in the 24 months prior to recruitment

Clinical diagnosis of HF and a supporting diagnostic echocardiogram

Must not have

Hemodynamic instability

Scheduled for cardiac rehabilitation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare an integrated disease management program for heart failure patients receiving treatment at a primary care facility to usual care. The primary outcome is a reduction in the total number of all-cause hospitalizations and ED visits.

Who is the study for?

This trial is for heart failure patients who've had a related hospital visit in the last 2 years, can understand English, and are stable enough to complete surveys. They should be classified as stage II-IV by NYHA standards and not enrolled in other cardiac studies or have severe kidney issues requiring dialysis.

What is being tested?

The study tests an integrated disease management program for heart failure at primary care facilities, including patient education and self-care skills training. It compares usual care with this new approach on hospital visits, emergency department trips, quality of life, and mortality.

What are the potential side effects?

Since the intervention involves education and self-management training rather than medication or invasive procedures, typical medical side effects are not expected. However, participants may experience stress or discomfort from changing their lifestyle or managing their condition differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been hospitalized or visited the ED for heart failure or heart issues in the last 2 years.

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I have been diagnosed with heart failure and had an echocardiogram.

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My heart condition is moderately to very limiting.

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My heart's pumping ability is either normal or below 45%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure and heart rate are stable.

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I am scheduled for heart rehab.

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I have trouble thinking or remembering which makes it hard for me to fill out forms.

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I am waiting for heart surgery.

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I am on dialysis due to severe kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite of all cause mortality, hospital admissions and emergency department visits

Secondary study objectives

Acute Heart Failure Episodes

Atlanta Heart Failure Knowledge Questionnaire

Health Service Use - Emergency Department visit

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Integrated Disease ManagementExperimental Treatment1 Intervention

Physicians randomized to intervention will attend a training session on the program standards and details of the IDM. Following the initial baseline interview a heart failure educator (HFE) will meet with subjects to obtain a detailed history of their HF, provide education, self-care management strategies (medication adherence, symptoms monitoring, dietary adherence, fluid restriction, exercise, weight management, smoking cessation) and review immunization status. A self-management action plan will be developed with the study physician and HFE to enable monitoring and management of HF by the participant.

Group II: Usual CareActive Control1 Intervention

Subjects will receive HF care as usually provided by their physician as advised or as needed. Study commitments for the control group include the initial interview, the expected time allotment for this initial visit is 1 hour. Telephone follow-up will occur at 3 months and 9 months to collect exacerbation data and maintain contact with participant. At 6 months and 12 months telephone follow-up will be conducted by the research assistant and the questionnaires will be completed.

0 / 9Eligibility criteria met