The Effect of telephone counseling based on Orem model on adherence to treatment and resilience of patients with coronary angioplasty
Design
Clinical trial with control group, with parallel groups, without blinding, randomized
Settings and conduct
80 patients with coronary angioplasty in hospitals affiliated to Shiraz University of Medical Sciences with CCU ward are divided into two groups of control and intervention by block randomization with size of 4 . The intervention includes telephone counseling related to adherence to treatment and resilience in the form of 3 telephone calls per week for 2 months. The control group receives only the usual hospital services. Two months after the intervention, both groups complete treatment adherence and resilience questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no severe mental illness and have a mobile phone and the ability to use it and the ability to communicate; Exclusion criteria: not implementing the intervention program completely and participating in the same care program in the last 3 months
Intervention groups
People in the intervention group receive telephone counseling regarding treatment adherence and resilience. Control group members they do not receive any intervention.
Main outcome variables
Adherence to treatment, resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210303050562N1
Registration date:2021-06-18, 1400/03/28
Registration timing:prospective
Last update:2021-06-18, 1400/03/28
Update count:0
Registration date
2021-06-18, 1400/03/28
Registrant information
Name
Mahsa Maryami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3753 1745
Email address
mahsamaryami93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-13, 1400/04/22
Expected recruitment end date
2021-09-13, 1400/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of telephone counseling based on Orem model on adherence to treatment and resilience of patients with coronary angioplasty
Public title
The effect of telephone counseling on patients with coronary angioplasty
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
No known severe mental illness
Ability to communicate and no hearing or speech problems
Mobile or landline access and knowledge of its use
Literacy for reading and writing
Age 18 to 65 years
Exclusion criteria:
Incomplete completion of questionnaires
Failure to implement the intervention program completely
Participate in a similar care program in the last 3 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, 80 patients with coronary angioplasty will be selected from among eligible individuals. Then, patients are divided into experimental and control groups based on a random quadruple block prepared using block generation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
Vice Chancellor for Research, 7th floor, shiraz university of medical science, zand st.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-05-27, 1400/03/06
Ethics committee reference number
IR.SUMS.REC.1400.167
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
121.9
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Adherence to treatment
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Questionnaire of adherence to treatment of chronic patients Madanloo 1392
2
Description
Resilience
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Resilience questionnaire for Ebadi heart and respiratory patients 2016
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, in addition to educational pamphlets and routine hospital care, telephone counseling will be provided for 2 months after discharge. Each patient will receive a mobile and home number, as well as the mobile number of a family member, and the patient will be given the researcher's mobile number. They will be provided with a schedule of telephone calls, which includes 3 calls per week for 2 months. The average call time will be 30 minutes. The call time range is from 8 am to 9 pm Also, if you have a problem or have a question, contact the researcher within the same time frame. The patient will be referred to a physician to follow up on patients' questions and problems if needed In the first telephone call, the client's needs are assessed using the Orem Needs Assessment Questionnaire, which includes three basic categories (general self-care needs, care needs for growth and development, self-care needs when deviating from health). To take. Then, based on the needs assessment, patients are evaluated and determined from three aspects in the field of nursing diagnosis, including: 1. Self-care treatment needs (which patient needs are met and which needs are not met, and what factors cause the needs to be met) ، 2. Self-care agent (patient's potential self-care abilities) 3. Decreased self-care (where the patient is weak and unable to take care of himself).In the next stage, the care plan will be designed and developed based on the goals in the form of educational-supportive nursing system, which includes: a- meeting the patient's needs in self-care b- making the patient responsible for self-care c- increasing the patient's independence in His care and adaptation to the changes that have been made and ... is. In fact, the role of the nurse in the education-support system of Orem is more of a counseling mode. For example, a heart patient with high blood cholesterol, a nurse with training on a healthy diet, including: (reducing the consumption of saturated fats (animal fats) and replacing them with unsaturated fats (vegetable oils), consuming omega-3 oils, reducing consumption Salt, weight loss, more consumption of fruits and vegetables, etc.) helps the patient to achieve self-care by increasing awareness of their diet. Also, the heart patient who has undergone angioplasty and his self-confidence has decreased due to limitations, the nurse helps the patient to trust in his / her abilities against the disease by focusing on the patient's abilities, strengthening positive behaviors and improving the patient's behavioral and mental performance in order to adapt to the disease. Feel good despite the limitations. At this stage, the planned nursing measures will be implemented in the form of supportive counseling, and finally the evaluation will be done based on the goals of reducing needs and increasing abilities through telephone calls and repetition and practice. The content of telephone calls generally includes the following: 1. Introduce yourself and ask questions about the patient's general health status 2. Giving health advice and education related to nutrition and medicine 3. Patient adherence to diet, medication, activity and exercise 4. Enhancing patient health behaviors and agreed behavioral goals. Strengthen disease acceptance and patient adaptation to conditions 6. End the call using incentive sentences and determine the time of the next call.
Category
Behavior
2
Description
Control group: do not receive telephone counseling over the phone, and educational pamphlets and standard hospital care include: (education about diet, activity, medications, and presentation of educational pamphlets about illness and medication) as well as how to see a doctor at the time of discharge will be provided.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital in shiraz
Full name of responsible person
Mahsa maryami
Street address
No.213, Alley42, Lashkari st., Rahmat Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7166714458
Phone
+98 71 3753 1745
Email
mahsamaryami93@gmail.com
2
Recruitment center
Name of recruitment center
Alzahra Heart Hospital, Shiraz
Full name of responsible person
Mahsa maryami
Street address
No.213, Alley42, Lashkari st., Rahmat Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7166714458
Phone
+98 71 3753 1745
Email
mahsamaryami93@gmail.com
3
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Mahsa maryami
Street address
No.213, Alley42, Lashkari st., Rahmat Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7166714458
Phone
+98 71 3753 1745
Email
mahsamaryami93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Deputy of Research and technology, 7th floor, Central building of Shiraz University of Medical Science, Zand street
City
Shiraz
Province
Fars
Postal code
7131811336
Phone
+98 71 3728 3235
Fax
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Khatereh Rostami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Namazi Square, Zand st.
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
khaterehrostami61@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khatereh Rostami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Namazi Square, Zand st.
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
khaterehrostami61@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa maryami
Position
MSc Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.213, Alley42, Lashkari Ave., Rahmat Blvd., Shiraz town
City
Shiraz
Province
Fars
Postal code
7166714458
Phone
+98 71 3753 1745
Email
mahsamaryami93@gmail.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