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Effects of peer support program on adherence to treatment of hypertension in patients with hypertension

Protocol summary

Summary
The aim of this study was to evaluate the effect of peer support on adherence to the treatment regimen and changes in blood pressure in patients with hypertension. Design : this study is a clinical trial. Entry and exit condition : a total of 64 patients presenting with hypertension , Setting and conduct , Participants including major eligibility criteria. Sampling were selected and randomly divided into control and experimental groups were done. Inclusion criteria, literate, fluent in Persian, history of hypertension, treated with at least one antihypertensive drug, having slurred speech or impaired hearing, age 18 and exclusion criteria of the study, the reluctance to continue to participate in the study, absent more than 2 sessions of meeting, held by those changes in concomitant medications and related educational programs. Intervention : Adherence to therapy of patients with hypertension questionnaire (which itself three drug regimen, diete regimen and mobility programs); in three phases : before the intervention, immediately after and one month after. The intervention, as well as blood pressure, height and weight of the patient is measured and recorded. Intervention : The intervention group at 6 meeting of the Subsidiary are held by the peer group and the control group participated in two training sessions organized by researchers participate. Main outcome measures : the results of the present study was to evaluate the effect of peer support on adherence of patients to treatment and changes in blood pressure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112125161N1
Registration date: 2016-01-17, 1394/10/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Amene Haidari
Name of organization / entity
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Country
Iran (Islamic Republic of)
Phone
+98 31 3226 0398
Email address
amaneheidare@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences Research Center
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of peer support program on adherence to treatment of hypertension in patients with hypertension
Public title
Effects of peer support program on adherence to treatment and Changes in blood pressure of hypertension in patients with hypertension center of Isfahan 2015.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study؛ proficiency in Persian؛ The history of high blood pressure treated with at least one antihypertensive drug؛ slurred speech or hearing impairment have 18 old. Exclusion criteria: lack of desire to continue to participate in the study؛ absence of more than 2 sessions of meetings held by peers؛ As in the training program associated with the company adhere to the treatment regimen during the study (now in excess of 2 sessions) ؛ create change in kinds of drugs the patient.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 64
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
Ethics Committee Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Street address
Isfaha University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan
City
Isfahan
Postal code
8345111111
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
394268

Health conditions studied

1

Description of health condition studied
hypertention
ICD-10 code
I10
ICD-10 code description
hypertension

Primary outcomes

1

Description
adherence to treatment
Timepoint
befor .after and after one mount
Method of measurement
questiner ofInventory adherence to treatment in patients with hypertension

Secondary outcomes

1

Description
Changes in blood pressure
Timepoint
Before, immediately after and one month later
Method of measurement
Set of blood pressure manitor

Intervention groups

1

Description
6 meeting holding support by counterparts in the intervention group and 2 non-related training session in Mntrl
Category
Prevention

2

Description
Control group : he group held two one-hour sessions on health issues by researcher
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hypertension Clinic ofis Isfahan
Full name of responsible person
Amener Haidari
Street address
Isfahan Cardiovascular Research Center, khorram avenue , Isfahan ,Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research , Isfahan University of Medical Sciences
Full name of responsible person
Dr Mahde Nematbakhsh
Street address
, Deputybof reserch Isfahan University Of Medical Sciences , Hezar Jrib avenue , Isfahan , Iran
City
Isfahan
Grant name
394268
Grant code / Reference number
394268
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Isfahan 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
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Full name of responsible person
Amene Heaidari
Position
MSC student of nursing
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan , Iran
City
Isfahan
Postal code
8345111111
Phone
+98 913 283 8648
Fax
+98 316699398
Email
Amaneheidare@nm.mui.ac.ir , Amaneheidare@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Full name of responsible person
Amene Haidari
Position
MSC student of nursing
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery , Hezar Jreb avenue , Isfahan , Iran
City
Isfahan
Postal code
8818613471
Phone
+98 3109132838648
Fax
+98 316699398
Email
amaneheidare@nm.mui.ac.ir , amaneheidare@yahoo.com
Web page address
not

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery
Full name of responsible person
Amene Haidari
Position
MSC student of nursing
Other areas of specialty/work
Street address
, Isfahan University Of Medical Sciences Faculty Of Nursing and Midwiery , HezarJereb avenue , Isfahan , Iran
City
Isfahan
Postal code
00988345111111
Phone
+98 132838648
Fax
+98 316699398
Email
Amaneheidare@nm.mui.ac.ir , Amaneheidare@yahoo.com
Web page address
NOT

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
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