Determination effect of telephone with face to face counseling on the quality of life in patients with hypertension
Design
A clinical trial study of three groups and multi-center. Sample size is determined based on pilot study. Randomization is based on random numbers table.
Settings and conduct
The city of Esfarayen has two comprehensive health centers and a total of nine health centers. Persons aged 40 to 60 years who are referred to these bases are selected based on cluster sampling and randomly selected
Participants/Inclusion and exclusion criteria
Inclusion criteria were at least 140 systolic blood pressure and diastolic blood pressure of 90, age 40 to 60 years and Exclusion criteria unwillingness to continue cooperation, Participate in previous telephone counseling, participate in previous counseling more than 3 hours
Intervention groups
In the first group, telephone counseling is performed once a week and the duration of each phone call is between 20-25 minutes and the duration of the intervention is three months. The second group is face-to-face counseling once a week and the time of each session is between 30-35 minutes and the duration of the intervention is three months.
Main outcome variables
Determining the quality of life before and after the intervention using the sf-36 questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141222020394N5
Registration date:2018-12-24, 1397/10/03
Registration timing:registered_while_recruiting
Last update:2018-12-24, 1397/10/03
Update count:0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
Mahbobeh Firooz
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 2650
Email address
mahbobehfirooz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chanvellor for Research esfarāyen univercity of Medical Sciences
Expected recruitment start date
2018-12-20, 1397/09/29
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of telephone versus face to face counseling on the quality of life of patients with hypertension
Public title
Effectiveness of telephone versus face to face counseling on the quality of life hypertension patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Able to communicate and is fluent in Persian
At least one year has passed since the history of hypertension
The age is between 40 and 60 years old
Echocardiography is normal
Exclusion criteria:
Underlying disease other than hypertension
The patient dont tends to continue this study
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
PASS software
Blinding (investigator's opinion)
Single blinded
Blinding description
Samples are taken from a multi healthcare centers. Each center is considered to be an intervention to blind the samples. Each sample contains one code, numbers: one, four, seven, and et al, for telephone counseling, numbers two, five, eight and et al, related to face to face counseling and numbers three, six, nine, and et al, related Will be to the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfarāyen Faculty of Medical Sciences
Street address
Imam Reza Street
City
Esfarayen
Province
North Khorasan
Postal code
76981-96618
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.ESFARAYENUMS.REC.1395.18
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I15
ICD-10 code description
Secondary hypertension
Primary outcomes
1
Description
Quality of life
Timepoint
before intervention, three months after intervention
Method of measurement
SF36 Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Telephone counseling is performed once a week and the duration of each phone call is between 20-25 minutes and the duration of the intervention is three months.
Category
Prevention
2
Description
Face-to-Face counseling once a week and the time of each session is between 30-35 minutes and the duration of the intervention is three months
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Malek Afzali Comprehensive Health Center
Full name of responsible person
Arezoo Kamizi
Street address
Behvarz S.t, Farmandari Square, Esfarayen
City
Esfarayn
Province
North Khorasan
Postal code
9661876981
Phone
+98 58 3155 0000
Email
kemiziamed@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Shokoohi Comprehensive Health Center
Full name of responsible person
Mohsen Shojae
Street address
Imam Khomeini S.t, Esfarayen
City
Esfarayen
Province
North Khorasan
Postal code
9661876981
Phone
+98 58 3723 8757
Email
mohsenshoja61@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfarāyen Faculty of Medical Sciences
Full name of responsible person
Eshagh Ildarabadi
Street address
Imam Reza Street
City
Esfarāyen
Province
North Khorasan
Postal code
76981-96618
Phone
+98 58 3723 8757
Email
Info@esfrums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarāyen Faculty of Medical Sciences
Proportion provided by this source
100
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
Esfarāyen Faculty of Medical Sciences
Full name of responsible person
Mahbobeh firooz
Position
Master of sciences in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Street
City
Esfarāyen
Province
North Khorasan
Postal code
76981-96618
Phone
+98 58 3724 1603
Fax
Email
MAHBOBEHFIROOZ@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfarāyen Faculty of Medical Sciences
Full name of responsible person
Mahbobeh firooz
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Street
City
Esfarāyen
Province
North Khorasan
Postal code
76981-96618
Phone
+98 58 3724 1603
Fax
Email
MAHBOBEHFIROOZ@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfarayen Faclty of medical sciences
Full name of responsible person
mahbobeh firooz
Position
member of faculty
Latest degree
Master
Other areas of specialty/work
مربی پرستاری
Street address
Esfarayen Faclty of medical sciences, Emam reza street, Esfarayen, Iran
City
esfarayen
Province
North Khorasan
Postal code
76981-96618
Phone
+98 58 3722 8757
Fax
Email
mahbobehfirooz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results will be informed public in the form of articles published in the journals
When the data will become available and for how long
after publish of the article
To whom data/document is available
All members of society
Under which criteria data/document could be used
To apply appropriate training method to patients with hypertension
From where data/document is obtainable
To medical science databases or journal page
What processes are involved for a request to access data/document
In an email to the author's documentation will be provided