Teach-Back Method on Quality of Life in Heart Failure Pat... | NCT03596359

Studies
Teach-Back Method on Quality of Life in Heart Failure Patients

NCT03596359

Sponsor

Baqiyatallah Medical Sciences University

Status

Completed

Last Update Posted

Jul 23, 2018Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Education with Teach-Back method
Received routine treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2016Actual

Primary Completion Date

Mar 2, 2017Actual

Completion Date

May 20, 2017Actual

First Submitted Date

Jun 25, 2018

First Submission Date that Met QC Criteria

Jul 20, 2018

First Posted Date

Jul 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2018

Last Update Posted Date

Jul 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammad Sadegh Bagheri Baghdasht, Principal Investigator, Baqiyatallah Medical Sciences UniversityPrincipal Investigator

Lead Sponsor

Baqiyatallah Medical Sciences UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Education with Teach-Back method	Behavioral		Test group
Received routine treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided