Protocol summary

Summary
The Aim Of This Study Was To Evaluate The Effect Of Family Centered Empowerment Model On The Blood Pressure And Dimensions Of Empowerment In Elderly People With Hypertension. The Inclusion Criteria Were Comprise Elderly People With 65 Years Old And More; Having Hypertension Disease 140/90 And More And Exclusion Criteria Were Comprise Unwillingness Of Patient Or His Family Member To Continue Cooperation In Empowerment Program. The Study Population Included All Elderly Peoples With Hypertension. The Required Number Of Participants With Using The Pocock Formula, Gigi Table And The Results Of The Pilot Study, 31 Elderly People Were Selected As An Experimental Group And The Same Number As The Control Group. For Experimental Group Family Centered Empowerment Model Was Implemented According To Its Four Steps Perception Threat, Self-Efficacy, Educational Participation And Evaluation In 14 Meeting For 45 Minutes For 4 Months. For Control Group Was Done Usual Care And One Educational Class. Primary Outcome Was The Mean Score Of Blood Pressure After The Intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041717315N1
Registration date: 2014-05-27, 1393/03/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-27, 1393/03/06
Registrant information
Name
Batool Hedayati
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7124
Email address
keshvari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Family-Centered Empowerment Model (Fcem) On The Blood Pressure And Dimensions Of Empowerment In Elderly People With Hypertension
Public title
The Effect Of Family-Centered Empowerment Model On The Blood Pressure And Dimensions Of Empowerment In Elderly People
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria Elderly People With 65 Years Old And More; Having Hypertension Disease 140/90 And More; Had A File In The Lenjan Health Center; The Interest Of Elderly People And One Of His Family Members To Participate In Research; Having The Minimum Read And Write Literacy; The Ability To Complete The Questionnaire And Participate In The Programs Of Empowerment; Not Having Any Specific Mental Illness; Exclusion Criteria Unwillingness Of Elderly Peoples Or His Family Member To Continue Cooperation In Empowerment Program; Lack Of Interest For Continuing The Completion Of Research Tools; Lack Of Participation In Group Discussion Meetings And Educational Partnership Programs;
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study elderly peope were ACCOMPANY with thier active family member

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University Of Medical Sciences
Street address
81726-73461, Hezar Jarib Street, Isfahan University Of Medical Sciences, Isfahan, Islamic Republic Of Iran.
City
Isfahan
Postal code
73461-81726
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
392189

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
110
ICD-10 code description
High blood pressure

Primary outcomes

1

Description
Mean Of Blood Pressure
Timepoint
4 MonthS
Method of measurement
Sphygmomanometer

Secondary outcomes

1

Description
Mean Score Dimensions Of Empowerment
Timepoint
4 months
Method of measurement
Dimensions Of Empowerment Questionnaire

Intervention groups

1

Description
In This Study Was Implemented Fcem According To Its Four Steps Perception Threat, Self-Efficacy, Educational Participation And Evaluation For Experimental Group.
Category
Lifestyle

2

Description
For Control Group Was Done Usual Care And One Educational Class.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Lenjan Health Center
Full name of responsible person
Batool Hedayati
Street address
Shariati Street, Lenjan Health Center, Lenjan township, Isfahan, Islamic Republic Of Iran
City
Lenjan Township

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Kazemi, Ph.D. In Nursing
Street address
81726-73461, Hezar Jarib Street, Isfahan University Of Medical Sciences, Isfahan, Islamic Republic Of Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Full name of responsible person
Batool Hedayati
Position
Student Of Msc, Community Health Nursing
Other areas of specialty/work
Street address
Hezar Jarib Street, Isfahan University Of Medical Sciences, Isfahan, Islamic Republic Of Iran.
City
Isfahan
Postal code
81746-73461
Phone
+98 31 1668 7153
Fax
+98 31 1669 9398
Email
parastaran2011@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahrokh Keshvari
Position
Ph.D. in nursing
Other areas of specialty/work
Street address
81746-7346, Hezar Jarib Street, Faculty Of Nursing And Midwifery, Isfahan University Of Medical Sciences, Isfahan, Islamic Republic Of Iran.
City
Isfahan
Postal code
81746-73461
Phone
+98 31 1668 7153
Fax
+98 31 1669 9398
Email
keshvari@med.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for updating data

Contact

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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