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CompletedNCT01886534CEASE-HFUpdated Dec 22, 2016

Caregiver Enhanced Assistance and Support for the Elderly Heart Failure Patient at Hospital Discharge (CEASE-HF)

An interventional study of Standardized Heart Failure Discharge Summary to Primary Care Physicians© and Standardized education sessions in Heart Failure, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-12-22.

Sponsored by McMaster University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Heart Failure

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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
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 78 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Enhanced Caregiver Support with Caregiver

    * 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

    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

  • Other
    Usual Care with Caregiver

    * Usual care

    Other: Usual care

  • Experimental
    Enhanced Support without Caregiver

    * 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

    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

  • Other
    Usual Care without Caregiver

    * Usual Care

    Other: Usual care

Interventions

  • OtherStandardized 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.

  • BehavioralStandardized education sessions

    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.

  • OtherHeart 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.

  • OtherDigital talking scale

    Prior to hospital discharge, the patient/caregiver dyad will be provided a digital, talking scale to measure their weight in their home setting.

  • OtherUsual care

    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.

06

What researchers measure

Primary outcomes

  1. Patient self care

    Self-Care Heart Failure Index (SCHFI) for patients and caregivers

    Time frame: 3 months

Secondary outcomes

  1. Death

    Deaths (due to cardiac and non-cardiac causes) during 3 months after hospital discharge

    Time frame: 3 months

  2. 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

    Time frame: 3 months

  3. Emergency room heart failure visits

    Emergency room heart failure visits (\< 24 hour hospital stay) during 3 months after hospital discharge

    Time frame: 3 months

  4. Perceived caregiver burden

    Modified Oberst Caregiver Burden Scale (CBS)

    Time frame: 3 months

  5. Heart failure knowledge acquisition

    Knowledge Acquisition Questionnaire (KAQ) for patients and caregivers

    Time frame: 3 months

  6. Medication adherence

    Medication Possession Ratio (MPR)

    Time frame: 3 months

  7. Referral to heart failure clinic or to long-term care

    Time frame: 3 months

  8. Health beliefs

    Health Beliefs Questionnaire (HBQ) for patients and caregivers

    Time frame: 3 months

  9. Depression

    Geriatric Depression Scale 8 (GDS-8) for the patient

    Time frame: 3 months

07

Study locations

1 site
  • McMaster University
    Hamilton, Ontario L8N3Z5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01886534
Lead sponsor
McMaster University
Responsible party
Catherine Demers (Associate Professor, McMaster University) — Principal investigator
First posted
Jun 26, 2013
Start date
Sep 2012
Primary completion
Apr 2014
Completion
Dec 2016
Last update
Dec 22, 2016

Study contacts

Catherine Demers, MD, MSc, FRCPC
principal investigator · McMaster University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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