Protocol summary

Summary
The objective of this study was to determined the effect of telephone nursing consult (telenursing) on adherence to diet and medication regimen and incidence of clinical manifestations in myocardial infarction patients. In this quasi-experimental study, 100 patients diagnosed with myocardial infarction were randomly allocated to experimental (n=50) or control (n=50) groups. At the beginning of the study, in an one-hour session, two groups were trained on the importance of treatment adherence, and training booklet was also given to the patients. Then the patients in the study group were under a nursing consultant with telephone for 12 weeks (in the 1st four weeks, twice a week and in the 2nd four weeks, once a week and in the 3rd four weeks, once every two weeks), while the control group did not receive any intervention. Before and after performing the interventions, diet adherence was measured by using diet adherence questionnaire, medication adherence by using Morisky medication adherence questionnaire, and the incidence of clinical manifestations by using a clinical manifestation form during the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409148505N8
Registration date: 2015-03-04, 1393/12/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-04, 1393/12/13
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-07-15, 1393/04/24
Expected recruitment end date
2014-09-15, 1393/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telephone nursing consult (telenursing) on adherence to diet and medication regimen and incidence of clinical manifestations in myocardial infarction patients
Public title
The effect of telephone nursing consult (telenursing) on adherence to diet and medication regimen and incidence of clinical manifestations in myocardial infarction patients referring to cardiovascular clinic affiliated to Shiraz university of medical science, 2014
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Having a heart attack for the first time; passing at least 2 months after the heart attack; confirming a definitive diagnosis of a heart attack and being under treatment; not being afflicted with a severe and life threatening disease; having heart ejection fraction of 30% or more; having no hearing and speaking problem; having access to telephone and knowing how to use it. Exclusion criteria: Were unwillingness to cooperate and have phone calls for more than 3 consecutive times; needing a coronary artery bypass surgery.
Age
No age limit
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 commitee of Shiraz University of Medical Sciences
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, next to Red Crescent Organization, Zand Street, Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
ct-93-7089

Health conditions studied

1

Description of health condition studied
myocardial infarction
ICD-10 code
I20,I21-I2
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Diet adherence
Timepoint
Before and 3 months after intervention
Method of measurement
Questionnaire

2

Description
Medication adherence
Timepoint
Before and 3 months after intervention
Method of measurement
Questionnaire

3

Description
Clinical manifestations
Timepoint
During the study
Method of measurement
Clinical manifestations form

Secondary outcomes

empty

Intervention groups

1

Description
Intervention in the study group: In a one hour training session, the patients received face to face training about importance of treatment adherence and training booklet was also given to the patients. Then, the patients were under a sustained nursing consultant with telephone for 12 weeks (in the 1st four weeks, twice a week and in the 2nd four weeks, once a week and in the 3rd four weeks, once every two weeks). The maximum call duration was determined 15 minutes and patients could decide on the contact time from 8 am to 8 pm. The contents of phone calls were as follows: researcher self-introduction and general addressing of the patient’s health condition, giving health advices and education about nutrition and medication, questioning the extent of the patient's adherence to diet and medication and incidence rates of clinical manifestations, reinforcement of healthy behaviors and finishing phone calls with motivational words and arranging the next call. In the case of any question or problem, they could contact the researcher at any time.
Category
Other

2

Description
Control group: In a one hour training session, the patients received face to face training about importance of treatment adherence and training booklet was also given to the patients.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiovascular clinics of Alzahra hospital
Full name of responsible person
Dr Kamran Aghasadeghi
Street address
Alzahra Hospital, Sibowyeh Blvd, Shiraz, Iran
City
Shiraz

2

Recruitment center
Name of recruitment center
Imam Reza polyclinic
Full name of responsible person
DR Kamran Aghasadeghi
Street address
Zand blvd, Namazi square, Next to Blood transfusion organazation
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Science
Full name of responsible person
Maryam Shabani
Position
Master science student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz, Fars
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3647 4254
Fax
Email
shabani@sums.ac.ir ; r.shabani224@gmail.com
Web page address
http://research.sums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Seyed Saeed Najafi
Position
MS in nursing - Faculty member
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz, Fars
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3647 4254
Fax
Email
s_najafi44@yahoo.com ; najafisa@sums.ac.ir
Web page address
http://research.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Seyed Saeed Najafi
Position
MS in nursing - Faculty member
Other areas of specialty/work
Street address
No. 1132, street 1/23, Valiasr town, Rahmat blvd
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
s_najafi44@yahoo.com ; najafisa@sums.ac.ir
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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