Heart FailureCEASE-HFNCT01886534
Caregiver Enhanced Assistance and Support for the Elderly Heart Failure Patient at Hospital Discharge (CEASE-HF)
A study testing Standardized Heart Failure Discharge Summary to Primary Care Physicians©, Standardized education sessions and Heart Failure Diuretic Decision Support Tool for Patient Self Management© in people with Heart Failure, run by McMaster University at 1 site in Canada.
Trial summary
Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at hospital discharge which may impact their ability to make effective decisions about their healthcare. However, informal care partners (CPs) may assist in managing HF when provided with appropriate education and support. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©, Standardized education sessions and Heart Failure Diuretic Decision Support Tool for Patient Self Management©
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Dec 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of Heart Failure (with preserved or impaired left ventricular systolic dysfunction) confirmed with the Boston Criteria >= 5 points
- 60 years of age or older
Who cannot join
- Residence in, or planned discharge to a long-term care facility (LTC)
- Life expectancy less than 3 months
- Patient transferred to Geriatric Rehabilitation unit
- No caregiver
- Residence is more than a 30 minute rive from hospital of discharge
- Patient refused to participate
Show all 18Show fewer
- Caregiver refused to participate
- Patient referred for CV surgery prior to hospital discharge
- Patient on IV Lasix at or bumetamide at hospital discharge
- Not on PO Lasix at hospital discharge
- Patient currently on dialysis
- Caregiver unavailable during daytime hours
- Caregiver has disability, serious mental illness or cognitive dysfunction
- Patient discharged early
- Patient enrolled in another randomized controlled trial
- Patient expired
- Patient and caregiver unable to speak and read English (Patient may be enrolled if nurse can converse minimally with patient and caregiver. S-TOFHLA will not be done for reading comprehension and questionnaires will be administered orally.)
- Severe aortic stenosis or severe mitral stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge
Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at hospital discharge which may impact their ability to make effective decisions about their healthcare. However, informal care partners (CPs) may assist in managing HF when provided with appropriate education and support. The goal of this randomized clinical trial (RCT) is to evaluate an intervention which will provide 1) additional teaching on management of HF to the patient and CP following hospital discharge, 2) improved communication with the family physician, 3) a HF decision support tool for oral diuretic management, and 4) a digital talking scale. The investigators believe this intervention will improve outcomes and be cost saving.
The investigators hypothesize that enhanced education and support for the CPs to assist older HF patients following hospital discharge, combined with improved communication with family physicians, contact with a HF nurse, and simple decision support tools, will lead to earlier recognition of clinical deterioration, and improved patient outcomes. Innovative and cost-effective approaches to manage HF patients following hospital discharge are urgently needed in Canada.
- Conditions
- Heart Failure
- Being tested
- Standardized Heart Failure Discharge Summary to Primary Care Physicians©, Standardized education sessions, Heart Failure Diuretic Decision Support Tool for Patient Self Management©, Digital talking scale, Usual care
- Keywords
- Heart failure, Heart diseases, Cardiovascular diseases, Health information technology, Disease management, Patient care management, Self care, Informal caregiver, Care partner, Peer support, Transitional care, Patient education, Teach-back, Clinical decision aid
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Heart Failure Discharge Summary to Primary Care Physicians©Other
At hospital discharge, in addition to usual care, the Study Nurse will fax an introduction letter and a 1-page comprehensive Standardized Heart Failure Discharge Summary to Primary Care Physicians© integrating Canadian Cardiovascular Society HF guideline recommendations to the patient's family physician.
Standardized education sessionsBehavioural
Following baseline data collection, and prior to hospital discharge or within 72 hours of discharge, all patient/caregiver dyads in the intervention group will receive a 45-60-minute standardized education session with the study nurse according to individualized patient learning needs, aimed to ensure similar baseline level of heart failure self-care knowledge. Verbal (teach-back) and written information from the Trial of Education And Compliance in Heart dysfunction (TEACH) RCT will be provided to all patient/caregiver dyads. Information regarding self-care such as dietary restrictions, exercise guidelines, weight and symptom monitoring (shortness of breath, swelling of the ankles) included in the education package will be reviewed. The teaching sessions will occur at 1 week, 2 weeks, 1 month and 2 months post-discharge.
Heart Failure Diuretic Decision Support Tool for Patient Self Management©Other
Each patient/caregiver dyad will be provided a paper-based Heart Failure Diuretic Decision Support Tool for Patient Self Management© at hospital discharge assisting in the titration of their oral furosemide. The purpose of this tool will be to assist the patient/caregiver in keeping track of signs and symptoms of worsening heart failure. The family physician will also be provided an access to similar decision support tool for management of clinical deterioration.
Digital talking scaleOther
Prior to hospital discharge, the patient/caregiver dyad will be provided a digital, talking scale to measure their weight in their home setting.
Usual careOther
Patients allocated to the usual care group will receive the hospital-approved heart failure management booklet which meets evidence-based requirements for outpatient heart failure management. Patients will meet with the hospital HF nurse-clinician (standard at this institution) to review heart failure symptoms and signs, diet and exercise recommendations. They will also meet with the ward pharmacist prior to hospital discharge to review medications and side effects. Referral to the HF clinic and any HF initiative will be left to the discretion of the most responsible physician.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Caregiver Support with Caregiver | Experimental | * Standardized Heart Failure Discharge Summary to Primary Care Physicians©
* Standardized education sessions
* Heart Failure Diuretic Decision Support Tool for Patient Self Management©
* Digital talking scale Receives: Other: Standardized Heart Failure Discharge Summary to Primary Care Physicians©; Behavioral: Standardized education sessions; Other: Heart Failure Diuretic Decision Support Tool for Patient Self Management©; Other: Digital talking scale; Other: Usual care |
| Usual Care with Caregiver | Other | * Usual care Receives: Other: Usual care |
| Enhanced Support without Caregiver | Experimental | * Standardized Heart Failure Discharge Summary to Primary Care Physicians©
* Standardized education sessions
* Heart Failure Diuretic Decision Support Tool for Patient Self Management©
* Digital talking scale Receives: Other: Standardized Heart Failure Discharge Summary to Primary Care Physicians©; Behavioral: Standardized education sessions; Other: Heart Failure Diuretic Decision Support Tool for Patient Self Management©; Other: Digital talking scale; Other: Usual care |
| Usual Care without Caregiver | Other | * Usual Care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self care
Self-Care Heart Failure Index (SCHFI) for patients and caregivers
Measured: 3 months
Secondary outcomes (9)
Death
Deaths (due to cardiac and non-cardiac causes) during 3 months after hospital discharge
Measured: 3 months
Heart failure readmission
Heart failure readmission (>= 24 hour hospital stay including the time spent in the emergency room with clinical evidence of heart failure) during 3 months after hospital discharge
Measured: 3 months
Emergency room heart failure visits
Emergency room heart failure visits (< 24 hour hospital stay) during 3 months after hospital discharge
Measured: 3 months
Perceived caregiver burden
Modified Oberst Caregiver Burden Scale (CBS)
Measured: 3 months
Heart failure knowledge acquisition
Knowledge Acquisition Questionnaire (KAQ) for patients and caregivers
Measured: 3 months
Medication adherence
Medication Possession Ratio (MPR)
Measured: 3 months
Referral to heart failure clinic or to long-term care
Measured: 3 months
Health beliefs
Health Beliefs Questionnaire (HBQ) for patients and caregivers
Measured: 3 months
Depression
Geriatric Depression Scale 8 (GDS-8) for the patient
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionDec 2016
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.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Demers, McMaster University
- Investigators
- Catherine Demers, MD, MSc, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886534
- Sponsor's protocol ID
- 11-638
- Acronym
- CEASE-HF
- Status last verified
- Dec 2016
- First submitted
- 21 Jun 2013
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge
- ClinicalTrials.gov ID
- NCT01886534
- Acronym / sponsor ID
- CEASE-HF / 11-638
- Conditions
- Heart Failure
- Keywords
- Heart failure, Heart diseases, Cardiovascular diseases, Health information technology, Disease management, Patient care management, Self care, Informal caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Jun 2013 (estimated)
- 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.
Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at hospital discharge which may impact their ability to make effective decisions about their healthcare. However, informal care partners (CPs) may assist in managing HF when provided with appropriate education and support. The goal of this randomized clinical trial (RCT) is to evaluate an intervention which will provide 1) additional teaching on management of HF to the patient and CP following hospital discharge, 2) improved communication with the family physician, 3) a HF decision support tool for oral diuretic management, and 4) a digital talking scale. The investigators believe this intervention will improve outcomes and be cost saving.
The investigators hypothesize that enhanced education and support for the CPs to assist older HF patients following hospital discharge, combined with improved communication with family physicians, contact with a HF nurse, and simple decision support tools, will lead to earlier recognition of clinical deterioration, and improved patient outcomes. Innovative and cost-effective approaches to manage HF patients following hospital discharge are urgently needed in Canada.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enhanced Caregiver Support with Caregiver | Experimental | Other: Standardized Heart Failure Discharge Summary to Primary Care Physicians©, Behavioral: Standardized education sessions, Other: Heart Failure Diuretic Decision Support Tool for Patient Self Management©, Other: Digital talking scale, Other: Usual care* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale |
| Usual Care with Caregiver | Other | Other: Usual care* Usual care |
| Enhanced Support without Caregiver | Experimental | Other: Standardized Heart Failure Discharge Summary to Primary Care Physicians©, Behavioral: Standardized education sessions, Other: Heart Failure Diuretic Decision Support Tool for Patient Self Management©, Other: Digital talking scale, Other: Usual care* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale |
| Usual Care without Caregiver | Other | Other: Usual care* Usual Care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of Heart Failure (with preserved or impaired left ventricular systolic dysfunction) confirmed with the Boston Criteria >= 5 points
- 60 years of age or older
Key exclusion criteria (18 listed)
- Residence in, or planned discharge to a long-term care facility (LTC)
- Life expectancy less than 3 months
- Patient transferred to Geriatric Rehabilitation unit
- No caregiver
- Residence is more than a 30 minute rive from hospital of discharge
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 |
|---|---|---|
| Standardized Heart Failure Discharge Summary to Primary Care Physicians©At hospital discharge, in addition to usual care, the Study Nurse will fax an introduction letter and a 1-page comprehensive Standardized Heart Failure Discharge Summary to Primary Care Physicians© integrating Canadian Cardiovascular Society HF guideline recommendations to the patient's family physician. | Other | Enhanced Caregiver Support with Caregiver, Enhanced Support without Caregiver |
| Standardized education sessionsFollowing baseline data collection, and prior to hospital discharge or within 72 hours of discharge, all patient/caregiver dyads in the intervention group will receive a 45-60-minute standardized education session with the study nurse according to individualized patient learning needs, aimed to ensure similar baseline level of heart failure self-care knowledge. Verbal (teach-back) and written information from the Trial of Education And Compliance in Heart dysfunction (TEACH) RCT will be provided to all patient/caregiver dyads. Information regarding self-care such as dietary restrictions, exercise guidelines, weight and symptom monitoring (shortness of breath, swelling of the ankles) included in the education package will be reviewed. The teaching sessions will occur at 1 week, 2 weeks, 1 month and 2 months post-discharge. | Behavioural | Enhanced Caregiver Support with Caregiver, Enhanced Support without Caregiver |
| Heart Failure Diuretic Decision Support Tool for Patient Self Management©Each patient/caregiver dyad will be provided a paper-based Heart Failure Diuretic Decision Support Tool for Patient Self Management© at hospital discharge assisting in the titration of their oral furosemide. The purpose of this tool will be to assist the patient/caregiver in keeping track of signs and symptoms of worsening heart failure. The family physician will also be provided an access to similar decision support tool for management of clinical deterioration. | Other | Enhanced Caregiver Support with Caregiver, Enhanced Support without Caregiver |
| Digital talking scalePrior to hospital discharge, the patient/caregiver dyad will be provided a digital, talking scale to measure their weight in their home setting. | Other | Enhanced Caregiver Support with Caregiver, Enhanced Support without Caregiver |
| Usual carePatients allocated to the usual care group will receive the hospital-approved heart failure management booklet which meets evidence-based requirements for outpatient heart failure management. Patients will meet with the hospital HF nurse-clinician (standard at this institution) to review heart failure symptoms and signs, diet and exercise recommendations. They will also meet with the ward pharmacist prior to hospital discharge to review medications and side effects. Referral to the HF clinic and any HF initiative will be left to the discretion of the most responsible physician. | Other | Enhanced Caregiver Support with Caregiver, Enhanced Support without Caregiver, Usual Care with Caregiver, Usual Care without Caregiver |
Primary outcome
Patient self care
Time frame: 3 months
Self-Care Heart Failure Index (SCHFI) for patients and caregivers
9 secondary outcomes
Death
Time frame: 3 months
Heart failure readmission
Time frame: 3 months
Emergency room heart failure visits
Time frame: 3 months
Perceived caregiver burden
Time frame: 3 months
Heart failure knowledge acquisition
Time frame: 3 months
Medication adherence
Time frame: 3 months
Referral to heart failure clinic or to long-term care
Time frame: 3 months
Health beliefs
Time frame: 3 months
Depression
Time frame: 3 months
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 22 Dec 2016.
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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.
Catherine Demers, MD, MSc, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Heart Failure Discharge Summary to Primary Care Physicians©, Standardized education sessions and Heart Failure Diuretic Decision Support Tool for Patient Self Management© in people with Heart Failure, run by McMaster University 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 2 inclusion and 18 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 22 Dec 2016. 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?
Patient self care (time frame: 3 months). 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 22 Dec 2016.