The aim of this study is to investigate the effect of self management program on self efficacy and control of disease in hypertensive patients. This is a semi-experimental clinical trial on 150 patients were recruited from health centers affiliated to Tehran University of Medical Sciences which have been sampled simply and randomized divided in to experimental and control groups. The control group received only routine visits, while the experimental group in addition to receiving usual care, will participate in self management program. then encouraged to accomplish self management program and followed up by telephone weekly for 8 week. At the end of fourth week, blood pressure measured in experimental and control groups. Then at the end of eighth week, the appointment, Blood pressure is measured, and questionnaire related to self efficacy and disease control in both control and experimental groups are completed and be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105314443N3
Registration date:2012-04-18, 1391/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-18, 1391/01/30
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self management program on control of disease and self efficacy in hypertensive patients
Public title
The effect of self management program on hypertensive patients control
Purpose
Supportive
Inclusion/Exclusion criteria
An inclusion criteria: tend to have participated in the study; 69-30 years old ;There Hypertension the mild and moderate (180-140mmhg systolic blood pressure and diastolic blood pressure between 110 to 90), which is confirmed by medical experts; not at the stage of acute disease; The ability to have a conversation in Farsi; read and write ; to establish direct telephone contact with the patient's home is there; difficulties in communication (hearing, etc.) is not; Hard and the underlying disease is not terminal: Such as metastatic cancer, kidney failure); Exclusion criteria: the patient dies during the study; stage of disease is acute and severe
Age
From 30 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Not 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
Street address
Tohid Square
City
Tehran
Postal code
Approval date
2011-07-28, 1390/05/06
Ethics committee reference number
14159
Health conditions studied
1
Description of health condition studied
primary hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
control of disease
Timepoint
before and after intervention
Method of measurement
control of disease questionnaire
Secondary outcomes
1
Description
self efficacy
Timepoint
before and after intervention
Method of measurement
self efficacy questionnaire
Intervention groups
1
Description
The control group received only usual care included drug therapy and advise to low salt and low fat regime
Category
Treatment - Other
2
Description
In experiment group, in addition to receiving the usual care group will participate in self management program. self management program with a day 4-hour workshop shall be conducted with patients with primary hypertension, in its first workshop and its objectives are described and will interact with participant ( formation of patient-provider partnership skill). Then educational materials about the nature of the disease, hypertension, risk factors, complications and control procedures, and complications of drug therapy (medical management areas), strengthening behavior and changes in health behavior (role management areas) and methods of stress reduction and management emotions such as anger, fear and despair, and ... (emotional management) by the researcher to speak at 100 minutes in two 50-minute rest period between the two lectures will be presented in 15 minutes. The second part of workshop, which takes 2 hours, then will designed Scenarios in relation to situations where patients with hypertension, may be faced with it, and discussion in small groups, patient information used in the workshop and Finally, is characterized by the correct way to handle situations designed to strengthen problem-solving skills, decision making skills. Also in workshop in the correct way to measure blood pressure, patients are taught and practiced and will ensure that the patient is taught how to correctly measure your blood pressure. The intervention focused on increasing acceptance of diet, nutrition, weight loss, reduced sodium intake, regular physical activity of moderate (walking every day) and smoking cessation and medication regimen is adhered.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Of Tehran University Of Medical Sciences
Full name of responsible person
Omolhoda Kaveh Savadkooh
Street address
Tohid square, Faculty of Nursing and Midwifery
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Mr Dr Photoohi, University Research Assisstant
Street address
Ghods street
City
Tehran
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
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
Masoumeh ZakeriMoghadam
Position
MS/Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
-
Phone
+98 21 6692 7171
Fax
-
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Lecturer/Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
MS./Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)