Investigation of the effect of mental health education intervention on the resilience and psychosocial adjustment of patients with heart failure under the care of counseling centers and nursing home services
Determination of the effect of mental health education intervention on the level of resilience and social psychological adjustment of patients with heart failure under the care of counseling centers and nursing home services at Shahid Rajaei Heart Center in Tehran
Design
Clinical trials with a control and experimental group with a sample size of 24 and randomly divided into control and experimental groups
Settings and conduct
Patients referred to a home care unit at the Shahid Rajaei Heart Center in Tehran by a physician. Social resilience and adaptability questionnaire are complemented before intervention. the home care program is performed by the researcher within a month, so the researcher will provide mental health training at home, then every 3 days he will have a phone call to follow up. A total of 15 follow-up calls are made. The researcher attends the patient's home twice a week and provides training for 6 sessions (one hour per session).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of advanced heart failure by the treating physician,18 years of age or older, resident of Tehran, hospitalization history of more than 1 time in the last 6 months and complete consent to participate in the study. Exclusion criteria: He has undergone heart surgery in the last 8 weeks, patients who In the last 4 weeks, they have had myocardial infarction, patients who have had cardiogenic shock in the last 4 weeks, and patients who have not been able to attend training courses due to complications or illness.
Intervention groups
In this study, in the intervention group, mental health education is given in the field of resilience and social psychological adjustment. In the control group, no intervention is performed.
Main outcome variables
In this study, patients' resilience and psychosocial adjustment are measured after mental health training.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200215046493N1
Registration date:2020-04-23, 1399/02/04
Registration timing:retrospective
Last update:2020-04-23, 1399/02/04
Update count:0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
ramin avazpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3875 4661
Email address
r_avazpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of mental health education intervention on the resilience and psychosocial adjustment of patients with heart failure under the care of counseling centers and nursing home services
Public title
Determination of the effect of mental health education on patients with heart failure under the care of counseling centers and home nursing services
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: definitive diagnosis of advanced heart failure by the treating physician, aged 18 years or older, resident of Tehran, hospitalization history more than 1 time in the last 6 months and full consent to participate in the study.
Exclusion criteria:
He has undergone heart surgery in the last 8 weeks, patients who have had a myocardial infarction in the last 4 weeks, patients who have had cardiogenic shock in the last 4 weeks, and patients who have not been able to attend training courses due to complications or illness. Be.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is block randomization using www.randomization.com website
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
shiraz
Province
Fars
Postal code
7477177751
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.SUMS.REC.1398.917
Health conditions studied
1
Description of health condition studied
Chronic heart failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
resilience
Timepoint
One week after mental health training
Method of measurement
Connor Davidson Resilience Questionnaire
2
Description
Psychosocial adjustment
Timepoint
One week after mental health training
Method of measurement
Social Psychological Adaptation Questionnaire pais
Secondary outcomes
1
Description
mental health
Timepoint
One week after the study
Method of measurement
Connor Davidson Resilience Questionnaire - Pais Social Psychological Adaptation Questionnaire
Intervention groups
1
Description
In the intervention group, the home care program is performed by the researcher within a month, so that during the first 6 hours after discharge, the researcher will provide mental health training at home, then every 3 days he will have a phone call to follow up. A total of 15 follow-up calls are made. The researcher attends the patient's home twice a week and provides training for 6 sessions (one hour per session).
Category
Lifestyle
2
Description
Control group: There are no interventions in the control group and only the questionnaires are filled before and after the study.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Heart Center in Tehran
Full name of responsible person
DR NASIM NADERI
Street address
Vali-e-Asr St. - Next to Mellat Park - Corner of Prayer of Shahid Rajaei Cardiovascular Training, Research and Treatment Center
City
TEHRAN
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
RAMINAVAZPOUR@YAHOO.COM
Web page address
http://rhc.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DR YOUNES GHASEMI
Street address
Shiraz, Zand St., Opposite Palestine St., Central Building of Shiraz University of Medical Sciences
City
SHIRAZ
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
Email
info@sums.ac.ir
Web page address
https://www.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr ladan zarshenas
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
South Bahonar St., South Industrialist, 31st Alley
City
shiraz
Province
Fars
Postal code
7477177751
Phone
+98 71 3875 4661
Email
raminavazpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr ladan zarshenas
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
South Bahonar St., South Industrialist, 31st Alley
City
shiraz
Province
Fars
Postal code
7477177751
Phone
+98 71 3875 4661
Email
raminavazpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr ladan zarshenas
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
South Bahonar St., South Industrialist, 31st Alley
City
shiraz
Province
Fars
Postal code
7477177751
Phone
+98 71 3875 4661
Email
raminavazpour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available