Protocol summary

Study aim
The purpose of the study is to investigate the effect of the family-centered empowerment model through telenursing on the treatment compliance of coronary artery transplant patients.
Design
Clinical trial with a control group, parallel groups with blinded outcome assessment and data analyzer, randomized, phase 3 on 60 patients. It will be used to randomize the randomization site.
Settings and conduct
The study site is Imam Ali Hospital in Kermanshah. Before the intervention, questionnaires of treatment compliance and self-efficacy are completed for both groups. In the second stage, the family-centered empowerment model will be implemented for the test group through the Eitaa messenger, and the questionnaires will be completed again for both groups. Blinding in this study is done for the outcome assessor and data analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria included performing coronary artery bypass surgery for the first time; having minimum literacy and non-entry criteria, including not using narcotics and psychotropic drugs; Non-participation in the training course is simultaneous with the implementation of the intervention.
Intervention groups
30 people in the control group are recipients of rehabilitation center programs. For 30 people in the test group, in addition to the routine programs, a two-hour workshop will be held in the hospital with the aim of familiarizing the participants with the working method and determining the active member of the family. Then, the four stages of the family-centered empowerment model, i.e., threat understanding, problem solving, educational participation, and evaluation through the Eitaa Messenger, will be implemented for 8 weeks.
Main outcome variables
The primary outcome of the study is adherence to treatment, and the secondary outcome is self-efficacy, which is measured through a questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180521039756N1
Registration date: 2024-05-02, 1403/02/13
Registration timing: prospective

Last update: 2024-05-02, 1403/02/13
Update count: 0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Parvin Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2102
Email address
p-abasi2003@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of the family-centered empowerment model through telenursing on the treatment compliance of coronary artery transplant patients
Public title
Investigate the effect of the family-centered empowerment model through telenursing on the treatment compliance of coronary artery transplant patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Coronary artery bypass surgery for the first time The patient and the active member of the family should have at least some literacy Living with family Having a smart mobile phone and the ability to use it and access the Internet
Exclusion criteria:
Having speech, vision, and hearing problems Participation in the training course at the same time as the implementation of the intervention Unwillingness to participate in research Having a history of major surgery in the previous 6 months Use of drugs and psychotropic drugs Having a history of mental disorder based on the patient's file
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will be done by the block method through the website www.randomization.com. According to the sample size of 60, 15 blocks of 4 (A, B) will be produced, where A will correspond to the intervention group and B will correspond to the control group. This step will be done by the researcher. In order to hide the resulting blocks, they will be written on a separate card and placed inside 15 opaque envelopes that are identical in appearance, and the order of the sequences will be written on the envelopes. For example, envelope number 1 has a sequence (AABB), and to use them, each envelope will be opened in order of numbering on the envelopes, and the next envelope sequence will not be used until the patients are taken. These envelopes will be given to the expert of the center who is not part of the research group, and then every qualified person will be placed in the intervention or control group by referring to him and removing the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, it is impossible to implement blinding for the trial participants and for the intervention administrators. However, the person responsible for distributing and collecting questionnaires will not know who is in the intervention or control group, and in other words, blinding will be done for the outcome examiner, and also blinding will be done for the data analyst, in the same order as for the information analyst. The contents of the letters (A, B), which represent the intervention and control groups, will remain hidden.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences Bld., Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.KUMS.REC.1402.657

Health conditions studied

1

Description of health condition studied
Ischemic heart disease
ICD-10 code
120-125
ICD-10 code description
Ischemic heart disease

Primary outcomes

1

Description
Adherence to treatment
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Questionnaire of adherence to treatment in chronic patients

Secondary outcomes

1

Description
Self-efficacy
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Cardiovascular disease management self-efficacy questionnaire

Intervention groups

1

Description
Intervention group: In this study, after holding a two-hour face-to-face workshop in the hospital with the aim of getting to know the patients, introducing and identifying a family member as a person who continues telenursing and obtaining the satisfaction of the patient, and an active family member to participate in the intervention, the family-centered empowerment model based on the four dimensions of perceived threat, self-efficacy, educational participation, and evaluation will be implemented for the test group. In the first and second stages of the model, that is, understanding the threat and increasing self-efficacy, the patient is expected to be aware of coronary artery bypass surgery and its complications, the factors involved in the development of heart diseases and preventive or modulating methods of these factors, lifestyle modification, stress management, And the type of physical activity after the operation, recommendations regarding having a healthy diet, and finally making the patient feel that "I can play a role in improving my condition" can be among the goals of these two steps. In order to implement the third step (educational participation), materials in the form of podcasts, posters, and educational videos will be provided to the active family member (for his participation in patient care) through Eitaa Messenger two days a week for eight weeks. The fourth step (evaluation of the process) is that the researcher will contact the active member of the family at the end of the week to ensure that the educational content is viewed and will answer their questions by phone. At the end, the final evaluation will be done after the implementation of the intervention in order to determine the effectiveness of the model by completing the questionnaire on adherence to treatment in chronic patients and self-efficacy in the management of cardiovascular patients.
Category
Lifestyle

2

Description
Control group: In this study, the patients in the control group will be the only recipients of the routine programs of the rehabilitation center of Imam Ali Hospital, and the questionnaires of adherence to treatment in chronic patients and self-efficacy in the management of cardiovascular patients will be completed by the patients once before the start of the intervention and once after the end of the intervention. And at the end of the research, in terms of ethical issues, educational topics will be provided to the control group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Parvin Abasi
Street address
Imam Ali Hospital, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0295
Fax
+98 83 3836 0043
Email
heartcenter@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
Research and Technology Vice-Chancellor, Medical Sciences Building No. 2, Shahid Beheshti Bl
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Fax
+98 83 3837 0541
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin Abasi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Daulat Abad Blvd., Isar Sq., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719816593
Phone
+98 83 3816 2559
Fax
+98 83 3826 1083
Email
p_abasi2003@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin Abasi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Daulat Abad Blvd., Isar Sq., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719816593
Phone
+98 83 3816 2559
Fax
+98 83 3826 1083
Email
p_abasi2003@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin Abasi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Daulat Abad Blvd., Isar Sq., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719816593
Phone
+98 83 3816 2559
Fax
+98 83 3826 1083
Email
p_abasi2003@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
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