Study of the effect of family-centered self-care program on medication and dietary regimen adherence in patients with acute coronary syndrome discharged from hospital
Determination of the effect of family-centered self-care program on medication and dietary regimen adherence in patients with acute coronary syndrome discharged from hospital
Design
This study is a two-group and three-stage clinical trial.
The researcher assessed the adherence to the dietary and pharmaceutical diet in both groups before and immediately before and 1.5 months after the intervention.
Settings and conduct
Sampling will begin at the hospital and CCU and intervention at home and with the family and patient care will be done.The person who will summarize the statistics will not know about the placement of samples in the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Have at least reading and writing skills in the patient and the main caregiver
The patient and his main caregiver will have an acquaintance in Persian.
Patient's home is in Isfahan.
Possibility to make phone calls and face-to-face visits with the patient and his caregiver
The sick person does not live alone.
The absence of mental illness, mental retardation, blindness, deafness and severe malignancy in the patient and his primary caregiver
Exclusion criteria:
Progression of illness during study or patient death
Unwillingness to continue participating in the study
Intervention groups
In this research, the standard home visits (starting, before, visit, ending, post-visit) steps will be followed.At the visiting stage, an educational and support intervention will be held during 5 to 7 sessions of 45 to 60 minutes with each test group and within 7 weeks (one week each week).
Control group members receive only routine nursing care (Pharmacotherapy and control of vital signs and the implementation of physician orders).
Main outcome variables
medication and dietary regimen adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180306038970N1
Registration date:2018-09-08, 1397/06/17
Registration timing:retrospective
Last update:2018-09-08, 1397/06/17
Update count:0
Registration date
2018-09-08, 1397/06/17
Registrant information
Name
Maryam Montazami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4522 3097
Email address
maryam.montazami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of family-centered self-care program on medication and dietary regimen adherence in patients with acute coronary syndrome discharged from hospital
Public title
The effect of family-centered self-care program in patients with acute coronary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least reading and writing skills in the patient and the main caregiver
The patient and his main caregiver will have an acquaintance in Persian.
Patient's home is in Isfahan.
Possibility to make phone calls and face-to-face visits with the patient and his caregiver
The sick person does not live alone.
Exclusion criteria:
The presence of mental illness, mental retardation, blindness, deafness and severe malignancy in the patient and his primary caregiver
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling patients easily, Then, the randomization was divided into two groups: intervention and control simply based on random numbers
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 Isfahan University of Medical Sciences
Street address
Hezar jarib Ave
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2018-03-05, 1396/12/14
Ethics committee reference number
396869
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
125.9
ICD-10 code description
NOS 125.9
Primary outcomes
1
Description
Mean score of medication adherence in Morisky questionnaire
Timepoint
Measurement of Medium medication Adherence before, Immediately and 1.5 months after the intervention
Method of measurement
Morisky questionnaire
2
Description
The mean of dietary adherence score in Neda Sanaei's dietary adherence questionnaire
Timepoint
Measurement of Medium dietary Adherence before, Immediately and 1.5 months after the intervention
Method of measurement
Neda Sanaei's Adherence to Dietary Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Implementation of family-centered self-care program in intervention group through 5 to 7 meeting sessions at the patient's home based on the pattern of visiting the patient home
Category
Lifestyle
2
Description
Control group: Complete relevant questionnaires and provide training for these patients after completing the study
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
Maryam Montazami
Street address
Salman farsi Ave, Pole shahrestan
City
Esfahan
Province
Isfehan
Postal code
73461-81745
Phone
+98 31 3260 0965
Email
shirani.farimah@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of Isfahan University of Medical Sciences
Street address
Hezar jarib Ave
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
keshvari@med.mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
60
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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Montazami
Position
Master of Community health nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, East 14th st, Mokhaberat Ave
City
Shahin shahr
Province
Isfehan
Postal code
8315717478
Phone
+98 31 4522 3097
Email
maryam.montazami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Montazami
Position
Master of Community health nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, East 14th st, Mokhaberat Ave
City
Shahin shahr
Province
Isfehan
Postal code
8315717478
Phone
+98 31 4522 3097
Email
maryam.montazami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Montazami
Position
Master of Community health nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, East 14th st, Mokhaberat Ave
City
Shahin shahr
Province
Isfehan
Postal code
8315717478
Phone
+98 31 4522 3097
Email
maryam.montazami@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