Protocol summary

Summary
The main objective: to determine the effect of multimedia self-care educational program on quality of life in hypertensive patients Inclusion criteria: age 18 and over, there is a definite diagnosis of hypertension by a physician , anti hypertensive medication for at least 3 months, a minimum of literacy, lack of sensory perception problems, disorders of vision, hearing and communication Exclusion criteria: absence of more than one of the training sessions for groups wanting to continue to participate in the study .The sample size in this study is 35 patients in each treatment group . for Patients in the intervention group, training sessions in hospital care was provided by the researcher, The meeting was scheduled for 20 minutes and sometimes up to 60 minutes according to patient need . the intervals between sessions is two days. They are trained to teach a group of up to 10 people with questions and answers, PowerPoint, and providing educational package leaflet and booklet and a CD with pictures and videos of training the content. Sf-36 quality of life questionnaire will be use, before and three months after the intervention for both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014060517980N1
Registration date: 2015-01-22, 1393/11/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-22, 1393/11/02
Registrant information
Name
Maryam Shahidi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11447483292
Email address
m.shahidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tehran University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of multimedia self-care educational program on quality of life in hypertensive patients
Public title
Impact on quality of life of patients with hypertension
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria :Age over 18 years;There is a definite diagnosis of hypertension by a physician ؛ History of blood pressure; medication for at least 3 months؛ minimal literate؛ Lack of understanding ;sensory problems; impairment of vision, Hearing and communication and Exclusion criteria : Absence of more than one of the training sessions for groups ;wanting to continue to participate in the study .
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Tehran University of Medical Sciences Ethics Committee
Street address
(Quds Street,tehran)
City
tehran
Postal code
Approval date
2014-04-16, 1393/01/27
Ethics committee reference number
130/105 /د/93

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10,I15
ICD-10 code description
High blood pressure Hypertension

Primary outcomes

1

Description
Quality of life
Timepoint
Before the intervention , Three months after the intervention
Method of measurement
Questionnaire SF-36

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group: Multimedia Self Care Educational"
Category
Other

2

Description
"Control group:Without Intervention"
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahmoodabad Shohada Hospital
Full name of responsible person
Maryam shahidi
Street address
Shohada Hospital, Mahmoodabad
City
Mahmoodabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Tehran University of Medical Sciences, Quds Street, Keshavarz Blvd, Tehran
City
Tehran
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 of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Najafi Qezeljeh
Position
Phd
Other areas of specialty/work
Street address
School of Nursing and Midwifery، N. East St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4323
Fax
Email
Taherehpaniz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences School of Nursing and Midwifery, Tehran
Full name of responsible person
Tahereh Najafi Qezeljeh
Position
Nursing Phd
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat East St, Tohid, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4323
Fax
Email
taherehpaniz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Shahidi
Position
Bachelor of Science in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, N. East St, Tohid, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4323
Fax
Email
Maryamshahidi@yahoo.com
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
Loading...