Protocol summary

Study aim
Determining the Effectiveness of Elderly Caregiver's Education through Virtual Social Networks on Adherence to the Drug and Food Regimen for People with Acute Coronary Disease
Design
A clinical trial with a control group based on patients over 60 years of age who were diagnosed with acute coronary artery disease in the CCU department and interviewed by caregivers who had been inclusion criteria in the study. The sample size is 90 people who were randomly divided into intervention and control groups(each group 45 people) using simple random sampling. Study is a single-blind.
Settings and conduct
The elderly were admitted to the CCU section of Loghman Hakim Sarakhs Hospital, which had criteria for entering the study.Study is a single-blind of health care personnel (physicians, nurses) responsible for patient care, data collection authorities And those who evaluate the outcome.
Participants/Inclusion and exclusion criteria
1- caregiver has been a member of the family or relatives of the elderly 2- Caregivers aged have been between 18-60 years old. 3- caregiver has been Member of the social network of telegrams and familiar with how to use it.
Intervention groups
In the Intervention Group, Educational Messages on Diet, Drugs and Activities are sent to Caregivers through the Social Network of Telegrams. During the Week, 18 Messages (6 Follow-Up Messages for the Diet, 6 Nutrition Messages and 6 Sports Messages Sent). These Tutorials Included Text Messages and Short Video Tutorials and Videos that Were Sent to Caretakers through Telegram Software. After Each Week, a One-Day Training Session was devoted to Reviewing the Content. There was No Specific Intervention in the Control Group and the Caregiver Received the Routine Permanent Training of the Hospital.
Main outcome variables
adherence to diet regimens

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171118037524N2
Registration date: 2018-07-08, 1397/04/17
Registration timing: retrospective

Last update: 2018-07-08, 1397/04/17
Update count: 0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34539208
Email address
nateghie94@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-27, 1396/08/05
Expected recruitment end date
2018-01-25, 1396/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Elderly Caregiver's Education through Virtual Social Networks on Adherence to Treatment for People with Acute Coronary Heart Disease
Public title
Investigating the Effect of Elderly Caregiver's Education through Virtual Social Networks on Adherence to Treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Member of the social network of telegrams and familiar with how to use it The definitive diagnosis of acute coronary heart disease is documented in the elderly medical records that they are caring for An elderly person under his or her care has not been diagnosed with cognitive impairment and depression and has not been treated to have an effective interaction with the elderly. Member of the social network of telegrams and familiar with how to use it Have literacy to read and write At least 18 years old and up to 60 years old
Exclusion criteria:
Unwillingness to continue caring or elderly involvement in research for any reason Eliminate elderly or caregiver for any reason (death, travel ...) Admission to the elderly or caregiver in the hospital
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization Using Random Numbers Table
Blinding (investigator's opinion)
Single blinded
Blinding description
1- Health care personnel (doctors, nurses) who are responsible for the care of patients. 2. Data collection authorities 3. Those who evaluate the outcome
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Asad Abadi Street - Central Organization of Sabzevar Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2017-04-12, 1396/01/23
Ethics committee reference number
IR.MEDSAB.REC.1395.134

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified

Primary outcomes

1

Description
Adherence to treatment
Timepoint
The beginning of the study (before the start of the training) and 6 weeks after the start of the training
Method of measurement
Adherence to treatment questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Educate the elderly carers by sending educational, nutritional, and therapeutic messages through the social network of the Telegram. During the week (from Saturday to Thursday, from 8 to 12 noon), 3 messages include dietary treatment, Nutrition and exercise status are sent. These tutorials included text messages and short video tutorials and videos that were sent to caretakers through telegram software. After each week, a one-day training session was devoted to reviewing the content. Training lasted for 6 weeks.
Category
Prevention

2

Description
Control group: Caregivers of elderly patients receive regular routine hospital education, including oral education pamphlets and nurses and their physician in the hospital.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Sarakhs Hospital
Full name of responsible person
Dr. Khadijeh Yekta Roodi
Street address
loghman Ave.
City
Sarahks
Province
Razavi Khorasan
Postal code
34528197
Phone
+98 51 3452 2228
Fax
+98 51 3452 8197
Email
Mjafarzade4@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Roya Akbarzade
Street address
Pardis ave.
City
Sabzevar
Province
Razavi Khorasan
Postal code
09906044744
Phone
+98 51 3452 9208
Email
mjafarzade4@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
70
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
Sabzevar University of Medical Sciences
Full name of responsible person
Bibi Sedighe Nateghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abotaleb Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9149958159
Phone
+98 34529208
Email
elaheenateghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Roya Akbarzade
Position
Faculty trainer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Ave.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 44018353
Email
roakbarzadeh53@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sedighe Rastaghi
Position
Faculty trainer
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Pardis Ave.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 990 604 4744
Email
sedighe_rastaghi@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
Not applicable
Data Dictionary
Not applicable
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