Nurse Telephone Follow-up for Cardiovascular Patients | NCT07120841

Studies
Nurse Telephone Follow-up for Cardiovascular Patients

NCT07120841

Sponsor

Mazandaran University of Medical Sciences

Status

Completed

Last Update Posted

Aug 13, 2025Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Depression, Anxiety Disorders
Follow-up Study
Cardiovascular Diseases

Interventions

Telephone Education
Standard Care (in control arm)

Countries

Iran

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

ID	Type	Description	Link
IR.MAZUMS.REC.1401.269	Other Identifier	Mazandaran University of Medical Sciences, Ethics Committee

Status Module

Record Verification Date

Aug 2025

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 23, 2023Actual

Primary Completion Date

Dec 21, 2023Actual

Completion Date

Dec 21, 2023Actual

First Submitted Date

Aug 6, 2025

First Submission Date that Met QC Criteria

Aug 6, 2025

First Posted Date

Aug 13, 2025Actual

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

Aug 6, 2025

Last Update Posted Date

Aug 13, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hossein Mohsenipouya, Assistant professor of health education and promotion, Mazandaran University of Medical SciencesPrincipal Investigator

Lead Sponsor

Mazandaran University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 aims to evaluate the effect of follow-up telephone education provided by a nurse on the levels of anxiety, stress, and depression in patients hospitalized in the cardiac intensive care unit during the two weeks after discharge. Patients will be randomly assigned to either the intervention (education) group or the control group. Their levels of anxiety, stress, and depression will be measured before and after the intervention. The aim is to determine whether this educational intervention can improve the psychological well-being of these patients.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental	Patients receive telephone follow-up education by nurse.	Behavioral: Telephone Education
Control Group	Active Comparator	Patients receive usual care without follow-up education.	Behavioral: Standard Care (in control arm)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telephone Education	Behavioral	Participants in this group will receive telephone follow-up education by a nurse during the two weeks after discharge	Intervention Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression, Anxiety, stress Score(DASS-21)	Changes in depression, anxiety, stress scores as measured by DASS-21	2 weeks after discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent obtained from both the patient and their family.
Definite diagnosis of heart disease confirmed by a specialist physician.
No previous history of psychological problems, based on the patient's medical records.
No prior participation in similar educational programs.

Exclusion Criteria:

Non response to the nurse's follow-up calls.
Failure to complete the survey.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

No restriction based on gender identity.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Khatam Hospital, Behshahr		Sari	Mazandaran	4817749365	Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data (IPD) will not be shared for this study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001008	Anxiety Disorders
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided