- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07120841
- Original Trial
Nurse Telephone Follow-up for Cardiovascular Patients (Nurse-TEL-CVD)
August 6, 2025 updated by: Hossein Mohsenipouya, Mazandaran University of Medical Sciences
Evaluation the Effect of "Nurse Telephone Follow-up" on Depression, Anxiety and Stress and Readmission of Cardiovascular Patients in Hospitalized Patients in Mazandaran Province
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mazandaran
-
Sari, Mazandaran, Iran, Islamic Republic of, 4817749365
- Khatam Hospital, Behshahr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Patients receive telephone follow-up education by nurse.
|
Participants in this group will receive telephone follow-up education by a nurse during the two weeks after discharge
|
|
Active Comparator: Control Group
Patients receive usual care without follow-up education.
|
Participants in this group will receive standard post-discharge care without any follow-up telephone education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression, Anxiety, stress Score(DASS-21)
Time Frame: 2 weeks after discharge
|
Changes in depression, anxiety, stress scores as measured by DASS-21
|
2 weeks after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2023
Primary Completion (Actual)
December 21, 2023
Study Completion (Actual)
December 21, 2023
Study Registration Dates
First Submitted
August 6, 2025
First Submitted That Met QC Criteria
August 6, 2025
First Posted (Actual)
August 13, 2025
Study Record Updates
Last Update Posted (Actual)
August 13, 2025
Last Update Submitted That Met QC Criteria
August 6, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.MAZUMS.REC.1401.269 (Other Identifier: Mazandaran University of Medical Sciences, Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be shared for this study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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