Protocol summary

Summary
The main objective of this study was to determine the effects of Self-Management Empowerment Model on social support receiving and a sense of coherence among elderly patients with cardiovascular disease. The main Inclusion criteria was age 60 years and older and having cardiovascular disease for at least 6 months to be approved by the cardiologist. Exclusion criteria included elderly patients' reluctance to participate in research. The sampling method was convenient, then Samples were allocated to case and control groups. After performing pre-test in both groups, in the experimental group, intervention in 5 steps based on the Self-Management Empowerment Model according to the patient's condition was performed at least two section and training manual contains guidelines to promote a sense of coherence and social support given to elderly patients. The control group received routine care. During 1.5 months after the first stage, the researchers tracked the status of the elderly, and after 1.5 months, the post-test was performed in both intervention and control groups. The data collected were analyzed. The expected outcomes of this study was to promote a sense of coherence and ability of social support receiving for the elderly.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014112813092N5
Registration date: 2015-01-17, 1393/10/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-17, 1393/10/27
Registrant information
Name
Maryam Ravanipour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
ravanipour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research -Bushehr University of Medical Sciences
Expected recruitment start date
2014-06-20, 1393/03/30
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Self Management Empowerment Model on Social Support receiving and Sense of Coherence among Elderly patients with Cardiovascular Diseases
Public title
Effect of Self Management Empowerment Model on Social Support receiving and Sense of Coherence among Elderly patients with Cardiovascular Diseases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 60 years and older; the patient's ability to understand, speak and educable; participation in the empowerment program; history of cardiovascular disease for at least 6 months before as affirmed by the cardiologist; lack of mental illness; not taking anti-anxiety drugs or psychotropic medication; residence in the city of Bushehr and Genaveh. Exclusion criteria: the patient's unwillingness and one of his companions to participate in the study; participate in the other training of heart disease in the period under study.
Age
From 60 years old to 95 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
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
Deputy for Research -Bushehr University of Medical Sciences
Street address
First Floor,Reasearch Assistance, Pardis site, Bushehr University of Medical Sciences, next to the Salman Farsi hospital, Sabzabad, Bushehr
City
Bushehr
Postal code
7514633341
Approval date
2014-04-17, 1393/01/28
Ethics committee reference number
B-92-15-19

Health conditions studied

1

Description of health condition studied
Cardiovascular Diseases
ICD-10 code
I10
ICD-10 code description
Hypertensive diseases

2

Description of health condition studied
Cardiovascular Diseases
ICD-10 code
I20
ICD-10 code description
Ischaemic heart diseases

3

Description of health condition studied
Cardiovascular Diseases
ICD-10 code
I30
ICD-10 code description
Other forms of heart disease

Primary outcomes

1

Description
Ability of social support receiving
Timepoint
Pre intervention, 1.5 months after intervention
Method of measurement
empowerment in receiving social support questionnaire of elderly patients with cardiovascular disease

Secondary outcomes

1

Description
Sense of Coherence
Timepoint
Pre intervention,1.5 months after intervention
Method of measurement
Antonovsky Sense of Coherence questionnaire,1987

Intervention groups

1

Description
In the intervention group, the elderly empowerment strategies in the area of sense of coherence and ability of social supports receiving, according to Self-Management Empowerment Model were performed in 5 steps. Such that the strategies depends on the patient's condition were taught to the patient,at least of two 45-minute sessions, then training manual given to patient.
Category
Lifestyle

2

Description
The control group received routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr Specialized Training Heart Center
Full name of responsible person
Mr Ebrahim Ebrahimi
Street address
Bushehr Specialized Training Heart Center, Moalem square, Bushehr
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Research -Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostovar
Street address
First Floor,Reasearch Assistance, Pardis site, Bushehr University of Medical Sciences, next to the Salman Farsi hospital, Sabzabad, Bushehr
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research -Bushehr 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
Deputy for Research -Bushehr University of Medical Sciences
Full name of responsible person
Seyyede Maryam Musavi
Position
MSc student of nursing,Student Research Committee, Bushehr University of Medical Sciences
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Pardis site, Bushehr University of Medical Sciences, next to the Salman Farsi hospital, Sabzabad, Bushehr
City
Bushehr
Postal code
7515756998
Phone
+98 77 3345 0187
Fax
Email
maryam_musavii@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Deputy for Research -Bushehr University of Medical Sciences
Full name of responsible person
Dr Maryam Ravanipour
Position
. Associate professor of Nursing, The Persian Gulf Tropical Medicine Research Center,Bushehr Univer
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Pardis site, Bushehr University of Medical Sciences, next to the Salman Farsi hospital, Sabzabad, Bushehr
City
Bushehr
Postal code
7515756998
Phone
+98 77 3345 0187
Fax
Email
ravanipour@bpums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Deputy for Research -Bushehr University of Medical Sciences
Full name of responsible person
Seyyede Maryam Musavii
Position
MSc student of nursing,Student Research Committee, Bushehr University of Medical Sciences
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Pardis site, Bushehr University of Medical Sciences, next to the Salman Farsi hospital, Sabzabad, Bushehr
City
Bushehr
Postal code
7515756998
Phone
+98 77 3345 0187
Fax
Email
maryam_musavii@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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