NCT01311583

Brief Summary

Patient education using Teach Back has the potential to increase self-care behaviour in heart failure (HF) patients and reduce adverse clinical outcomes. Teach back is an interactive teaching method that uses plain language, focuses on key points, and asks the patient to verbally recall information just discussed. Questions are asked to confirm patient understanding of the information delivered. This pilot study will be conducted to evaluate the effectiveness of teach back on self-care (as measured by the European Heart Failure Self-Care Behaviour Scale- EHFScBS) and determine if teach back affects the number of ER visits and re-admissions post discharge. The study will also assess if teach back technique is a feasible, acceptable and sustainable method of discharge teaching for hospitalized HF patients at St Michael's.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

February 22, 2011

Last Update Submit

January 7, 2016

Conditions

Keywords

Self-careTeach Back

Outcome Measures

Primary Outcomes (3)

  • self-care behaviour score

    mailed questionaire

    change from baseline in self-care behaviour score at one week.

  • self-care behaviour score

    mailed questionaire

    change from baseline in self-care behaviour score at one month

  • self-care behaviour score

    mailed questionaire

    change from baseline in self-care behaviour score at three months

Secondary Outcomes (6)

  • patient visits to ER or admission to hospital

    one week since discharge

  • patient visits to ER or admission to hospital

    at one month since discharge

  • patient ER visits or admission to hospital

    three months since discharge

  • impact on nurses' workload

    up to 12 weeks from the last enrolled patient

  • satisfaction with the training for the nurses' to provide teach back

    up to 12 weeks from the last enrolled patient

  • +1 more secondary outcomes

Study Arms (2)

usual care plus Teach Back intervention

ACTIVE COMPARATOR

Trained nurses will provide Teach Back to the intervention group. The nurses' training will focus on the concepts of Teach Back, provide coaching and guidance on how to use it as well as review the principles of conducting research. Role play will be a feature in the education sessions to improve the nurses' comfort level

Behavioral: Teach Back method of patient discharge teaching

usual care

NO INTERVENTION

All participants will experience the current practice of discharge teaching: daily interaction with the interdisciplinary team members via rounds, counseling on diet and medications with a dietician and pharmacist when referred, view the Heart Failure Discharge Video, and receive a Congestive Heart Failure education package which includes the Heart and Stroke "Managing Congestive Heart Failure" booklet.

Interventions

Trained nurses will provide Teach Back to the intervention group. Appendix D lists the four questions that will be used in this study to confirm the patient's understanding. The nurses' training will focus on the concepts of Teach Back, provide coaching and guidance on how to use it as well as review the principles of conducting research. Role play will be a feature in the education sessions to improve the nurses' comfort level

usual care plus Teach Back intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the in-patient cardiology (7CCS) or Coronary Care Unit (CCU), with documentation of HF as the most responsible diagnosis
  • Prescribed a diuretic such as Lasix plus or minus Metolazone
  • New or established diagnosis of HF

You may not qualify if:

  • Cognitive impairment
  • Suffer from a co-existing, severe, chronic debilitating disease
  • Require hemo or peritoneal dialysis, have planned surgical intervention that will impact the etiology or manifestation of HF symptoms
  • Life expectancy of less than three months
  • Unable to receive discharge teaching, or are unable to communicate on the telephone
  • Already enrolled in a patient education study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ada Andrade, MN

    St. Michael's

    PRINCIPAL INVESTIGATOR
  • Vimy Barnard-Roberts, MN

    St. Michael's

    STUDY CHAIR
  • Haytham Sharar, MN

    St. Michael's

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2011

First Posted

March 9, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

February 1, 2013

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations