Integrated Disease Management of Heart Failure in Primary Care

March 16, 2023 updated by: Lawson Health Research Institute

Integrated Disease Management of Heart Failure in Primary Care; A Cluster Randomized Trial

The study population includes primary care physicians and heart failure (HF) patients attending one of over 100 family physicians in seven family health teams in Southwestern Ontario. Study purpose is to measure the effect of an integrated disease management (IDM) program for people diagnosed with HF and receiving treatment at a primary care facility. Components of IDM include HF specific patient education and self care management skills training by a heart failure educator. Study outcomes include health service use, HF symptoms, quality of life, and HF knowledge assessment compared to the usual care group.

The primary objective of this study is composite and will measure the effect of integrated disease management (IDM) on all cause hospitalizations, ED visits and mortality events. Secondary outcomes will include HF related hospitalizations, HF related ED visits, quality of life, mortality, other health service utilization, acute HF episodes, NYHA class. We hypothesize HF specific IDM implemented in primary care will be superior to usual physician-based care measured by a combined reduction in the total number of all cause hospitalizations and ED visit events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study population will be identified through patients attending one of 100 family physicians from 10 different family health teams (FHTs) or family health organizations (FHOs) in the Southwestern Ontario.

Study Design: A parallel cluster randomized trial design has been chosen comparing the intervention arm (patients entered on the IDM) to the control arm (patients receiving usual care). A multi-level study design is proposed, level 3 the FHT/FHO, level 2 the physician and level 1 the HF patient. We have chosen to randomize at level 2, the physician and implement the intervention at both level 2 and 1, the physician and the individual. Outcomes will be measured at individual level. Stratified randomization of physicians will be performed by FHT/FHO, giving greater balance between arms and increased power and precision by reduction of between cluster variability.

Recruitment: Physicians from the FHTs/FHOs will be invited to participate and informed consent will be obtained. The physician will be randomized to either the control or intervention group and randomization will be computer generated by FHT/FHO strata. Allocation for overall study will be 1:1 as will allocation by FHT/FHO. Each participating primary care site will identify all individuals with a HF diagnosis in their care suitable for the trial and a simple random sample will be taken from this group to obtain the desired cluster size. An initial telephone call will be arranged with the patient to discuss study details, obtain informed consent, further determine eligibility, and complete questionnaires.

Data management: As a part of the objectives of this study a POSS electronic tool has been developed, all data collected about the participants will be entered by heart failure educators and stored in a central server. Access is restricted to authorized personnel only. The POSS has been designed not only as a secure storage depot but also as a tool to standardize the data collected minimizing information bias. There is extensive data checking at the time of data entry. Data definitions are incorporated to support quality data inputs.

Sample Size: With a minimum recruitment of 50 physicians recruited and 4 participants per physician, this study would be powered to detect a minimum 36% reduction in the rate of number of hospitalizations or ED visits per person year with an attrition rate of 20%. This calculation is based on 80% power to 5% significance with an ICC of 0.05.

If 100 physicians are recruited with 2 to 3 participants per physician (and a total sample size of 280) the study will have 90% power to detect a 35% reduction in the primary outcome.

Statistical Analysis: Analysis will be on an intention to treat basis. Baseline data will be used to characterize the study population, to identify any imbalances between arms. Continuous data will be displayed as mean ±standard deviation and count (percent) for categorical variables (variables to be presented will be predetermined in an analysis plan). Due to over dispersion that occurs in this type of count data the primary outcome (and health service utilization secondary outcomes) will be analyzed using a negative binomial distribution with random effects to account for clustering and for individuals experiencing multiple events. The results will be presented as rate ratios. The secondary outcomes (change in KCCQ at 6 months and other knowledge and QoL metrics) will be analyzed at individual level using logistic regression, results will be presented as odds ratios. Reliability will be assessed by using a quadrature check and in the event of failure a generalizing estimating equation (GEE) model will be fitted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Madonna Ferrone
  • Phone Number: 519-564-5900
  • Email: argi@cogeco.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Science Center, Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New York Heart Association (NYHA) classification of stage II, III or IV
  • a clinical diagnosis of HF and a supporting diagnostic echocardiogram
  • HF or cardiovascular related hospitalization and/or ED visit in the 24 months prior to recruitment
  • Patients with HF with a preserved ejection fraction and HF with a reduced ejection fraction (<45%) will be included.

Exclusion Criteria:

  • hemodynamic instability
  • awaiting cardiac surgery
  • expected survival rate of <1 year due to terminal illness
  • lack of English language skills
  • reduced cognitive function that affects the ability to complete the questionnaires
  • enrolment in other cardiac trials
  • formalized HF education (e.g. Telehomecare) in the six months prior to enrolment
  • scheduled for cardiac rehabilitation
  • severely impaired renal function requiring dialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Integrated Disease Management
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.
Other: Integrated Disease Management
Multidisciplinary intervention comprising of patient education, self management strategies and medication optimization
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of all cause mortality, hospital admissions and emergency department visits
Time Frame: 1 year
The primary outcome will be a composite of the total number of all-cause mortality, hospital admissions, and ED visits events. This measure will be the rate of events per person year at risk. The ED visits will be visits that do not lead to hospitalization.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life using KCCQ
Time Frame: 6 months and 1 year
Quality of life measure using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An improvement in total score will indicate an improvement in health status and quality of life. The range is score is from 0-100
6 months and 1 year
Mortality
Time Frame: 1 year (rate number of events per person year of follow-up)
All cause mortality rate
1 year (rate number of events per person year of follow-up)
Health Status using EQ-5D
Time Frame: 6 months and 1 year
Measure health status of health for clinical and economic appraisal using the EQ-5D. The EQ-5D is a self-administered questionnaire and is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An decrease in total score will indicate an improvement in health status. The range of the scale is from 5-25.
6 months and 1 year
Health Status using SF-12
Time Frame: 6 months and 1 year
Measure overall health status using the SF-12. The SF-12 is a self-administered questionnaire that measures physical and mental health composite scores with twelve questions that range from 0-100. An improvement in score will indicate an improvement in health status.
6 months and 1 year
Health Service Use - Hospitalization
Time Frame: 1 year (rate number of events per person year of follow-up)
Number of heart failure related hospitalizations during study. Number of all-cause hospitalizations during study.
1 year (rate number of events per person year of follow-up)
Health Service Use - Emergency Department visit
Time Frame: 1 year (rate number of events per person year of follow-up)
Number of heart failure related emergency department visits. Number of all-cause emergency department visits during study.
1 year (rate number of events per person year of follow-up)
Atlanta Heart Failure Knowledge Questionnaire
Time Frame: 1 year
The Atlanta Heart Failure Knowledge Questionnaire (AHFKQ) consists of 30 questions and was developed to ascertain knowledge about HF, treatment, and self-care.
1 year
The Mediterranean Diet Questionnaire
Time Frame: 1 year
The Mediterranean Diet is a 14-item questionnaire to assess adhesion to a Mediterranean diet, proven to be beneficial to people with heart failure
1 year
NYHA
Time Frame: 1 year
NYHA: The NYHA is a classification system for the extent of HF. It classifies patients in one of four categories based on limitations during physical activity due to symptoms of HF
1 year
Health Service Use -unscheduled physician visits
Time Frame: 1 year (rate number of events per person year of follow-up)
Number of heart failure related unscheduled physician visits
1 year (rate number of events per person year of follow-up)
Health Service Use -urgent care facility visits
Time Frame: 1 year (rate number of events per person year of follow-up)
Number of heart failure related urgent care facility visits
1 year (rate number of events per person year of follow-up)
Acute Heart Failure Episodes
Time Frame: 1 year (rate number of events per person year of follow-up)

An acute HF episode will be recorded if the participant experiences any of the following:

i. Worsening signs or symptoms of HF leading to an unscheduled physician visit and/or urgent care facility.

ii. Worsening signs or symptoms of HF leading to a visit to an ED. iii. Worsening signs or symptoms of HF leading to hospitalization. iv. Worsening signs or symptoms of HF leading to an activation of action plan
1 year (rate number of events per person year of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Licskai, Lawson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LawsonHRI03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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