Heart FailureHFF-EDNCT03246035
Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure
A study testing Intervention Group in people with Heart Failure and Acute Decompensated Heart Failure, run by Jewish General Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Acute Decompensated Heart Failure, Fragility
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 1 Mar 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Pilot Trial to Reduce Readmission for Frail Elderly Patients With Acute Decompensated Heart Failure
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.
Read the detailed 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.
- Being tested
- Intervention Group, Control Group (Standard Care)
- Keywords
- Acute Decompensated Heart Failure, Heart Failure, Frailty, Geriatrics, Self-care, Emergency Medicine, Cardiology, Patient Oriented Research
- Medical subject headings
- Heart Failure, Emergencies, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
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.
Control Group (Standard Care)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard Care) | Active comparator | The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital. Receives: Other: Control Group (Standard Care) |
| Intervention Group | Experimental | The intervention will consist of contacting the patient 5 days post-discharge and arranging definitive outpatient follow-up and providing targeted medical and lifestyle advice based on deficient domains identified at baseline. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death, hospital readmission, or ED revisit
Measured: 90 days
Secondary outcomes (10)
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.
Measured: 30 days
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.
Measured: 90 days
Incidence of adverse effects from medication
Number of patients who experience unexpected side effects from their heart failure medications
Measured: 90 days
Self-Care Index
Change in the Self-Care Heart Failure Index from enrollment to follow-up
Measured: 90 days
Heart Failure Symptom Scale
Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up
Measured: 90 days
Frailty Index
Change in the Frailty Index from enrollment to follow-up
Measured: 90 days
Recruitment rate
The number of eligible of patients recruited into the study over a 3 month trial period
Measured: 90 days
Attrition rate
The number of patients enrolled the study who choose to leave the study before completing the follow-up
Measured: 90 days
Informed consent validation (qualitative)
Qualitative feedback from participants regarding the informed consent process
Measured: 90 days
All-cause death, hospital readmission, or ED revisit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Mar 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Association of Emergency Physicians
- Responsible party
- Principal investigator, Jonathan Afilalo, Jewish General Hospital
- Investigators
- Jonathan Afilalo, FRCPC, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246035
- Sponsor's protocol ID
- ADHF-ED-JGH
- Acronym
- HFF-ED
- Status last verified
- Oct 2022
- First submitted
- 28 Jun 2017
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Trial to Reduce Readmission for Frail Elderly Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT03246035
- Acronym / sponsor ID
- HFF-ED / ADHF-ED-JGH
- Keywords
- Acute Decompensated Heart Failure, Heart Failure, Frailty, Geriatrics, Self-care, Emergency Medicine, Cardiology, Patient Oriented Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- Canadian Association of Emergency Physicians
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard Care) | Active comparator | Other: Control Group (Standard Care)The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital. |
| Intervention Group | Experimental | Behavioral: Intervention GroupThe intervention will consist of contacting the patient 5 days post-discharge and arranging definitive outpatient follow-up and providing targeted medical and lifestyle advice based on deficient domains identified at baseline. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupFor 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. | Behavioural | Intervention Group |
| 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 | Other | Control Group (Standard Care) |
Primary outcome
All-cause death, hospital readmission, or ED revisit
Time frame: 90 days
10 secondary outcomes
Rate of return visits to any ER for any medical issue
Time frame: 30 days
Rate of admission to hospital at 90 days
Time frame: 90 days
Incidence of adverse effects from medication
Time frame: 90 days
Self-Care Index
Time frame: 90 days
Heart Failure Symptom Scale
Time frame: 90 days
Frailty Index
Time frame: 90 days
Recruitment rate
Time frame: 90 days
Attrition rate
Time frame: 90 days
Informed consent validation (qualitative)
Time frame: 90 days
All-cause death, hospital readmission, or ED revisit
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Afilalo, FRCPC principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Heart Failure and Acute Decompensated Heart Failure, run by Jewish General Hospital at 1 site in Canada.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause death, hospital readmission, or ED revisit (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2022.