NCT03596359

Brief Summary

This study determines effect of education with Teach-Back method in patients with Heart failure. In this randomized clinical trial, 70 patients with Heart failure hospitalized in year 2016-17 were selected and they were randomly divided into control group and test group.Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the case group, and control group received routine treatment. Information have collected whit Demographic questionnaire and SF36 questionnaire before and after training. Data were analyzed by Spss version18 And there were analyzed by descriptive statistics and Chi-square, Independent T-test, Paired T-test and Co-variance tests.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable heart-failure

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

Study Start

First participant enrolled

November 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

June 25, 2018

Last Update Submit

July 20, 2018

Conditions

Heart Failure

Keywords

Self CareHeart FailureQuality of LifeTeach-Back

Outcome Measures

Primary Outcomes (2)

  • SF 36 questionnaire

    SF36 questionnaire was used to measuring the quality of life

    Up to 48 hours

  • Demographic questionnaire

    Demographic questionnaire was used to collect information

    24 hours

Study Arms (2)

Test group

EXPERIMENTAL

Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the Test group

Behavioral: Education with Teach-Back method

Control group

ACTIVE COMPARATOR

The control group received routine treatment

Other: Received routine treatment

Interventions

Education with Teach-Back methodBEHAVIORAL
Test group
Received routine treatmentOTHER
Control group

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 45 to 85
  • Heart failure diagnosed six months ago
  • The Ejection Fraction less than 45
  • Have reading and writing skills
  • Have perfect consciousness
  • Fluency in Persian

You may not qualify if:

  • Patient do not cooperate with researchers
  • The inability of each sample to continue cooperation during the study because of the problem or acute disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 23, 2018

Study Start

November 18, 2016

Primary Completion

March 2, 2017

Study Completion

May 20, 2017

Last Updated

July 23, 2018

Record last verified: 2018-07