Protocol summary

Summary
This study aimed to evaluate the impact of person-centered care model based on adherence to treatment in patients with heart attack. Inclusion criteria included the definitive diagnosis of a heart attack; stay in intensive care unit at least 72 hours; having the ability to communicate verbally Exclusion criteria included the patient's death; re-infarction heart; not wanting to continue to cooperate. The study population included all patients with a heart attack admitted to Shahid Beheshti University of Medical Sciences hospitals. Of the population, 100 patients with heart attack were selected as samples of this study. In the intervention group, care was provided based on person-centered model for 5 steps and three consecutive days. The control group was given only the usual care. Treatment adherence was measured in the two groups.

General information

Acronym
person-centered models
IRCT registration information
IRCT registration number: IRCT2017022232730N1
Registration date: 2017-06-14, 1396/03/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Farzaneh Soleimany
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 935 726 6767
Email address
soleimany.f@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-08-21, 1395/05/31
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of person-centered models based care on the medication adherence in patients with myocardial infarction
Public title
Study of the effect of person-centered models based care on the medication adherence in patients with myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who are hospitalized in the intensive care unit with a diagnosis of heart attack; Patients who are hospitalized in the intensive care unit for at least the next 72 hours (to continue with treatment), patients who have the capacity to establish verbal communication; Patients who do not have cognitive impairment and vision and have the ability to comply with their treatment regimen Exclusion Criteria: Patients who die during the study period; Patients who have a re-heart stroke during the study period; Patients who do not wish to continue to participate in the study.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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 the School of Nursing and Midwifery
Street address
Tehran-Valiasr-Niayesh intersection-front of Rajaei hospital
City
Tehran
Postal code
Approval date
2016-08-11, 1395/05/21
Ethics committee reference number
IR.SBMU.PHNM.1395.461

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
treatment adherence
Timepoint
pre- 3weeks-2months
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
During August- November 2016 in the intervention group, a person-centred nursing process was added to care, as usual, emphasizing the patient as a partner in care. Care was constructed in cooperation between patients, registered nurses, and researcher.
Category
Lifestyle

2

Description
The control group received only usual care.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Reza Shokri
Street address
Saadat Abad Boulevard, District 2, Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Taleqani Hospital
Full name of responsible person
Bashiri Pour
Street address
Taleqani St, District 1, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Sima Zohari Anbohi
Street address
Shahid Beheshti School of Nursing and Midwifery, Valiasr street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery
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
School of Nursing and Midwifery
Full name of responsible person
Faraneh Soleimany
Position
Master of Nursing
Other areas of specialty/work
Street address
Shahid Beheshti School of Nursing and Midwifery, Valiasr street, Tehran
City
Tehran
Postal code
Phone
+98 935 726 6767
Fax
Email
nurse.iniran@gmail.comsoleimany.f@sbmu.ac.irsoleimany.faraneh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Sima Zohari Anbohi
Position
PHD
Other areas of specialty/work
Street address
Shahid Beheshti School of Nursing and Midwifery, Valiasr street, Tehran
City
Tehran
Postal code
Phone
+218 8202511
Fax
Email
simazohari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Farzaneh Soleimani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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