Protocol summary

Summary
This clinical trial will be done to determine the effect of peer support group on elderly self-empowerment suffering from hypertension. The study intervention is peer support group and is performed on elderly suffering from hypertension in Tehran. Study sample will be randomly allocated in the experimental and control groups. There are 36 samples in experimental group and 36 samples in control group. Since the suitable size for each peer support group is about 8-10 persons, we will have 3 intervention group. The sessions of peer support groups will be held for 8 weeks and each session about 2 hours. In each session the subject of discussion will be chosen based on the problems which will be mentioned from the participants and their interests about what they want to know about their disease. At first session a plan of the next 7 sessions will be formed based on the priority of the needs in each group. At the beginning of the next 7 sessions the researcher will speak about the subject of the session for 5 minutes and then group members will share their experiences and at the end of the session the discussion will be summarized.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016090429696N1
Registration date: 2017-07-02, 1396/04/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-02, 1396/04/11
Registrant information
Name
mohammadreza saeedi
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 51210021
Email address
m.saeedi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shahed University
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer support group on empowerment of self-efficacy in elderly patients with hypertension
Public title
The effect of peer support group on empowerment of self-efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Tendency to participate in research; Older than 60 years old; favorable physical condition for participating in group, ability of speaking and completing the questionnaire; Having systolic blood pressure higher than 140 and diastolic blood pressure higher than 90; knowing Persian for participating in group ; favorable cognitive status for participating in group that is measured by short cognitive test (ATMs), If the score is higher than 7 they will have inclusion criteria. exclusion criteria: If elderly don't want to participate through the process of research, they will be deleted from the final analyze.
Age
From 56 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
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 of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran
City
Tehran
Postal code
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.Shahed.REC.1394.288

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
110
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
self efficacy
Timepoint
Before the intervention in first session and at the end of intervention
Method of measurement
Sherer General Self-Efficacy Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
There are 3 groups in in the intervention group In each group the participants share their experiences in group..General self-efficacy questionnaire will be completed before and after intervention. In first section,educational needs of participants will be asked and it will be prioritized and other sections it will be discussed.
Category
Lifestyle

2

Description
There isn't any intervention for control group. The control group will be completed questionnaires two times( before and after the intervention).
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
municipality neighborhood house in Theran
Full name of responsible person
Dr Maryam Jadidmilani
Street address
yosefabad-jahanara st-15 alley
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Shahed University
Full name of responsible person
Shahed University Vice chancellor for research : Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, 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 Shahed University
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
Shahed University
Full name of responsible person
Maryam Jadid Milani
Position
PhD of nursing
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran
City
tehran
Postal code
Phone
+98 21 6641 8590
Fax
Email
m.saeedi@shahed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Jadid Milani
Position
PhD of nursing
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran
City
tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
milani@shahed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr Maryam Jadidmilani
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
milani2000ir@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
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