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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
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