The effect of interdisciplinary discharge planning on therapeutic adherence, Readmission, and Cardiovascular Health Indicators in patient with coronary vascular angioplasty
Determination and comparison of mean score of adherence to therapeutic regimen, clinical status, para clinical status and re-admission in patients undergoing coronary angioplasty between the intervention and control groups
Design
This study is a blind clinical trial with two intervention groups and a control group. The blindness of this study in single blind that will be conducted on the participants in the study.
The participants of this study will be patients who are admitted to CCU ward of Vali-e-Asr hospital in Fasa , who will undergoing coronary angioplasty between 2018 and 2019.
The sample size of this research is based on previous studies and using the formula for comparing two meanings, calculated by the Stata 11software that is eighty objects for each group. .
The method of sampling of this research is accessible (convenience). In this way, all patients referred to the CCU will be divided into two intervention and control groups after fill the informed consent form.
Settings and conduct
vali asr hospital in Fasa
Participants/Inclusion and exclusion criteria
Inclusion criteria: admission in the heart ward of Vali Aasr hospital , undergoing to coronary angioplasty technique;
Exclusion criteria: patients deny to participate
Intervention groups
The intervention group is trainig by interdisciplinary teams during three sessions (one week, one month and three months after discharge)
Main outcome variables
therapeutic adherence, Readmission, and Cardiovascular Health Indicators
General information
Reason for update
Acronym
CVA
IRCT registration information
IRCT registration number:IRCT20190316043065N1
Registration date:2019-05-14, 1398/02/24
Registration timing:registered_while_recruiting
Last update:2019-05-14, 1398/02/24
Update count:0
Registration date
2019-05-14, 1398/02/24
Registrant information
Name
Elaheh Rahpeima
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 6412
Email address
e.rahpeima@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of interdisciplinary discharge planning on therapeutic adherence, Readmission, and Cardiovascular Health Indicators in patient with coronary vascular angioplasty
Public title
The effect of interdisciplinary discharge planning on therapeutic adherence, Readmission, and Cardiovascular Health Indicators in patient with coronary vascular angioplasty
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Admission to the heart ward of the Vali Asr Hospital of Fasa,
the use of coronary artery angioplasty method
telephone access
lack of Disabling illnesses
lack impairment of speech, hearing and vision
speaking ability
complete satisfaction for precipitate in the study
Exclusion criteria:
Lack of satisfaction,
Alzheimer's history
proven psychological disorders
other advanced diseases other than heart problems, such as cirrhosis, cancers, rheumatoid diseases
inability to communicate
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
All patients referring to the CCU section during sampling time will be divided into two intervention and control groups after completing the informed consent via block randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
After obtaining informed consent from subjects, they are randomly assigned to intervention or control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Fasa University of Medical Sciences
Street address
Avicenna Sq, Fasa, Fars, Islamic Republic of Iran
City
Fasa
Province
Fars
Postal code
86688-74616
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.FUMS.REC.1397.181
Health conditions studied
1
Description of health condition studied
Cardiovascular disease
ICD-10 code
160-169
ICD-10 code description
Cardiovascular disease
Primary outcomes
1
Description
Therapeutic adherence
Timepoint
Admission time, one month after discharge, three months after discharge
Method of measurement
Therapeutic adherence questionnaire
2
Description
Readmission
Timepoint
three months
Method of measurement
re-admission via questionnaire
3
Description
Cardiovascular Health Indicators
Timepoint
three months
Method of measurement
laboratory test and cardiovascular indexes through cardiac physical exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The training of the intervention group will be conducted by the members of the interdisciplinary team during three sessions.
Category
Prevention
2
Description
Control group: The control group will be routinely trained.. In order to comply with the ethical principles, at the end of the study, the manual will be provided to the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali- Asr hospital
Full name of responsible person
Shahnaz Karimi
Street address
Vali- Asr Hospital, Ibn Sina Sq
City
Fasa
Province
Fars
Postal code
74617-47377
Phone
+98 71 5331 5012
Fax
+98 71 5331 4021
Email
e.rahpeima@fums.ac.ir
Web page address
http://vh.fums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Fargham
Street address
Avicenna Sq, Fasa, Fars, Islamic Republic of Iran
City
Fasa
Province
Fars
Postal code
86688-74616
Phone
+98 71 5335 0994
Fax
+98 71 5335 7091
Email
e.rahpeima@fums.ac.ir
Web page address
http://www.fums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa University of Medical Sciences
Proportion provided by this source
100
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
Fasa University of Medical Sciences
Full name of responsible person
Shahnaz karimi
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Fasa University of Medical Sciiences
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5333 0649
Email
sh.karimi16@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Shahnaz Karimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
NO. 8, Alley 5, Shekofe Street
City
Fasa
Province
Fars
Postal code
7461431835
Phone
+98 71 4333 0649
Email
sh.karimi16@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Elaheh Rahpeima
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences ;Ibn Sina Sq
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5333 6412
Email
e.rahpeima@fums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Their data will not be published to protect subjects.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Publish through article extraction
When the data will become available and for how long
2020
To whom data/document is available
Researchers of Medical Sciences and other enthusiasts
Under which criteria data/document could be used
Implementation in other centers or other disease
From where data/document is obtainable
shahnaz karimi
Assistant Professor of Medical Education
Department of Nursing, School of Nursing and Midwifery
Fasa University of Medical Science
What processes are involved for a request to access data/document