Protocol summary

Study aim
Determining the effect of Educational Package with the help of the Health Literacy Index (INDEX) on medication adherence and hypertension management in elderly patients with primary hypertension
Design
In this research, 120 eligible elderly referring to Cardiovascular clinic were chosen purposefully Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
Among all elderly with hypertension who referred to the Cardiology Clinic of Shaheed Fayyaz Bakhsh Hospital, who have criteria for entering the study, 120 elderly are selected and the study process is briefly explained to them. Then, if the elderly desire, they will receive written informed consent and all elderly people will be asked to complete the demographic profile, health literacy and medication adherence questionnaire. Then all samples will be randomly assigned in two groups of intervention and control. Control group received the usual services from the clinic and the intervention group was divided into small groups (to save time and affordability) and during two sessions attending the clinic in the first and second weeks and four telephone conversations in the third And fourth weeks will be taught By using content Adapted to the level of health of people, with the help of the Health Literacy Index. After fifteen days of last telephone conversation, patients were followed up again, to determine the mean of blood pressure in individuals. For examining possible changes after the test, questionnaires used in Pre-test completing again after intervention. Finally, data collected from the research.
Participants/Inclusion and exclusion criteria
including Criteria : Age over 60 years old, using anti hypertensive drugs, ability to speak Persian and able to communicate with researchers, inadequate health literacy based on helia health literacy questionnaire exclusion criteria: Psychiatric disorders (dementia, depression) with patient self-report, drug addiction, hospitalization, patient death, reluctance to continue cooperation, don't complete educational program (one meeting and two telephone calls)
Intervention groups
Patient education via using an educational package with the help of the Health Literacy Index
Main outcome variables
medication adherence- management of hypertension

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171227038097N1
Registration date: 2018-02-26, 1396/12/07
Registration timing: registered_while_recruiting

Last update: 2018-02-26, 1396/12/07
Update count: 0
Registration date
2018-02-26, 1396/12/07
Registrant information
Name
Farzane Delavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 5524
Email address
f-delavar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of patient education based on Health Literacy INDEX on medication adherence and hypertension management in elderly patients with primary hypertension
Public title
The effect of educational package with the help of health literacy index on medication adherence and hypertension management in elderly patients with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All people over the age of 60. Elderly who have ability to speak Persian and communicate with scholars. All elder people who have been suffering from primary hypertension for at least one year before entering the study. All people who are taking antihypertensive medications. Elderly people who have 66 score or less in Helia Health Literacy Questionnaire.
Exclusion criteria:
Psychiatric disorders (dementia, depression) Addicted people to drugs Hospitalization Death Unwillingness to continue cooperation Do not Complete the curriculum (one meeting and two phone calls)
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
After collecting basic information, all samples are randomly assigned block size of 4 in two groups of intervention and control. For generating random sequences used from the randomizer.org website, and for conceal allocation , dark envelopes will be used to specify the group name. Then, according to the order of entering samples, envelope number one is opened for the first sample and the group will be identified.
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethic committee of Tehran University of Medical Sciences
Street address
بلوار کشاورز، خیابان قدس، دانشگاه علوم پزشکی تهرا
City
Tehran
Province
Tehran
Postal code
0000000000
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3687

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Percentage of People with Hypertension- Medication adherence in morisky questionaire
Timepoint
Measurement of hypertension and medication adherence at the beginning of the study and fifteen days after the end of intervention
Method of measurement
Morisky medication adherence Questionnaire - blood pressure monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Control group received the usual services from the clinic and the intervention group was divided into small groups (to save time and affordability) and during two sessions attending the clinic in the first and second weeks and four telephone conversations in the third And fourth weeks will be taught By using content Adapted to the level of health of people, with the help of the Health Literacy Index.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
درمانگاه قلب بیمارستان شهید دکتر فیاض بخش
Full name of responsible person
Dr Hossein Bayat
Street address
next to the Vitana factory, at the beginning of Khayij street, old Karaj road, km 7, Tehran
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6400 5673
Email
h.bayat@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
دکتر محمدعلی صحرائیان
Street address
Department of Research and Technology, Sixth floor, Central Organization of the University, Ghods Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8163 3685
Email
m.sahraeian@sina.tums.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
Tehran University of Medical Sciences
Proportion provided by this source
25
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
Tehran University of Medical Sciences
Full name of responsible person
Farzane Delavar
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, East Nosrat, Tohid squ.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6105 4580
Email
f-delavar@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, East Nosrat, Tohid squ.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6105 4581
Email
negarandeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzane Delavar
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, East Nosrat, Tohid squ.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6105 4580
Email
f-delavar@razi.tums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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