Objectives: The current study will aim to determine the effect of continuous care model on self-management and adherence to treatment of patients with myocardial infarction in control of the complications of this disease.
Method: This is a Not blind clinical trial performed on 82 patients with myocardial infarction referring to Ali ibn Abitaleb Hospital in Rafsanjan. Patients with myocardial infarction who are 25 to 85 years old with at least reading and writing skills and the patient's interest and one of their family members are required to participate in the research. Participants will be randomly assigned to two groups of control and intervention. The continuous care model will be implemented on the intervention group. The continuous care model consists of four steps: (1) orientation, (2) sensitivity, (3) control, and (4) assessment. patients in the control group also will receive routine care. Self-management and adherence to treatment in both groups will be assessed using self-management questionnaires in chronic patients and follow-up therapy in cardiac patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017083035996N1
Registration date:2017-10-15, 1396/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Mohammad Ali Zakeri
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3420 9346
Email address
m.zakeri@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Kerman University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect the Application of Continuous Care Model on Self-management and Adherence to treatment in patients with Myocardial infarction
Public title
Effect the Application of Continuous Care Model on Self-management and Adherence to treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the age range of 25 to 85 years old; having the minimum read and write literacy; confirming of infarction by clinical symptoms; serum enzyme tests and ECG changes; the interest of the patient and one of his family members to Participate in research; not having any specific mental illness; the ability to complete the questionnaire and participate in the programs of empowerment؛
Exclusion criteria: impossibility or unwillingness of patient for returning to the hospital for the next stage of intervention after discharge; patients’ lack of ability to learn due to aging; participate in the training course concerning heart disease in the studied Period; the unwillingness of the patient or his family member to continue cooperation in empowerment program; lack of interest in continuing the completion of research tools; lack of participation in problem-solving meetings and educational partnership programs.
Age
From 25 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
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 Kerman University of Medical Sciences
Street address
Haft-Bagh, Kerman Medical University Campus, Kerman University of Medical Sciences, Kerman
City
Kerman
Postal code
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.Kmu.REC.1395.893
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Self-management
Timepoint
Before the intervention, one month after the intervention and three months after the end of the intervention
Method of measurement
Self-management questionnaire
Secondary outcomes
1
Description
Adherence to treatment
Timepoint
Before the intervention, one month after the intervention and three months after the end of the intervention
Method of measurement
Adherence to the treatment in cardiac patients questionnaire
Intervention groups
1
Description
Intervention group: Continuous Care Model includes four stages of awareness, sensitivity, control, and evaluation. Care counseling will provide to patients in the intervention group along with a family member in 6 sessions of group training for one month at Ali ibn Abi Talib Hospital.
Category
Rehabilitation
2
Description
control group: Patients in the control group will receive routine care (discharge training)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib Hospital
Full name of responsible person
Nasrin Jandaghi
Street address
Ali ibn Abi Taleb Hospital, Ayatollah Saeedi Square, Rafsanjan
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Abas Pardakhti
Street address
Research management, Deputy of Research and Technology University, Ibn Sina Ave, Tahmase Abad Cross, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Razi Nursing Faculty, Kerman University of Medical Sciences
Full name of responsible person
Mohammad Ali Zakeri Bazmandeh
Position
Graduate Student, Faculty of Nursing and Midwifery Razi
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery Razi, Campus of the University of Medical Sciences, Beginning of Alavi Highway, Kerman
City
Kerman
Postal code
Phone
+98 34 3428 0011
Fax
Email
m.zakeri@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farokh Abazari
Position
Ph.D, Nurse
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery Razi,Campus of the University of Medical Sciences, Beginning of Alavi Highway, Kerman
City
Kerman
Postal code
Phone
+98 34 3132 5288
Fax
Email
f_abazari@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Ali Zakeri Bazmandeh
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Rafsanjan
City
Nursing Town, Rafsanjan
Postal code
Phone
+98 34 3428 0011
Fax
Email
m.zakeri@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)