Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03246035
Other study ID # ADHF-ED-JGH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date March 1, 2022

Study information

Verified date October 2022
Source Jewish General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized study designed to determine whether telephone based interventions can prevent return hospital visits for elderly and frail patients with acute symptoms of heart failure. Specifically, the intervention will improve patients ability to monitor and address self care of heart failure at home.


Description:

Acute decompensated heart failure (ADHF) is a common illness in Canadian emergency departments (ED). The frail subset of elderly patients with ADHF is challenging to treat, use a large proportion of available resources, and are at higher risk for complications, including readmission to hospital after discharge. The investigators believe that by improving access to follow-up, optimizing self-care, and addressing the various cognitive and physical limitations of frailty, it will be possible to improve quality of life and reduce readmission rates for frail patients with ADHF.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 1, 2022
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients who presented to the ED and who are being discharged with a primary or secondary diagnosis of ADHF - Age = 65 - Frailty, defined as a FRAIL score >=3/5 or Clinical Frailty Scale (CFS) score >=5/9 - Informed consent provided by the patient or proxy Exclusion Criteria: - Significant dementia or active delirium - Severe frailty, defined as a CFS score >=8/9 - Prohibitive language barrier - Primary address outside of Quebec - Patient deemed to be palliative or moribund by treating team

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention Group
For the intervention arm, a specialized heart failure nurse practitioner will contact the patient or their primary caregiver by telephone within 5 days post-discharge and send them an education packet by mail. During the telephone call, the nurse will (1) confirm the patient's scheduled follow-up appointment in cardiology, (2) provide recommendations for heart failure self-care behaviors that were found to be deficient at baseline. Patients will then be referred to a Geriatrics Assessment Team, who will provide individualized recommendations for frailty domains that were found to be deficient at baseline. The technique used to provide educational recommendations will be motivational interviewing.
Other:
Control Group (Standard Care)
For patients randomized to the Control Group (Standard Care), they will receive their follow-up visits, medications, diet and physical activity advice as they normally would. This is the care they would receive even if they were not enrolled in the study

Locations

Country Name City State
Canada Jewish General Hospital Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Jewish General Hospital Canadian Association of Emergency Physicians

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause death, hospital readmission, or ED revisit 90 days
Secondary Rate of return visits to any ER for any medical issue Number of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period. 30 days
Secondary Rate of admission to hospital at 90 days Number of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period. 90 days
Secondary Incidence of adverse effects from medication Number of patients who experience unexpected side effects from their heart failure medications 90 days
Secondary Self-Care Index Change in the Self-Care Heart Failure Index from enrollment to follow-up 90 days
Secondary Heart Failure Symptom Scale Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up 90 days
Secondary Frailty Index Change in the Frailty Index from enrollment to follow-up 90 days
Secondary Recruitment rate The number of eligible of patients recruited into the study over a 3 month trial period 90 days
Secondary Attrition rate The number of patients enrolled the study who choose to leave the study before completing the follow-up 90 days
Secondary Informed consent validation (qualitative) Qualitative feedback from participants regarding the informed consent process 90 days
Secondary All-cause death, hospital readmission, or ED revisit 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy