Protocol summary

Summary
This is an interventional study that aims to investigate the effect of family-centered empowerment model on life style and illness perception of patients with heart failure. 70 patients with diagnosis of heart failure refer to researcher from cardiologist. Inclusion criteria: age between 18-65y/o; at least in class II heart failure; at least literacy(writing&reading) for patient and one of active family member; predominant to Persian language. Exclusion criteria: to become manifest of physical and mental disease; progress to class IV heart failure and become more deteriorated. After completion of demographic, disease's perception and life style questionnaire by participants, divided to case and control group by randomized block. Case group and active family members participate in 5 sessions(1-2hours) about family-centered empowerment model for 5 weeks. Control group receive pamphlet about heart failure. after 45 days reassess life style and patient's perception.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014072018468N3
Registration date: 2015-02-23, 1393/12/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Khadijeh Rahimi kordshouli
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4457 0383
Email address
rahimi_kh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of family-centered empowerment model on life style and illness perception of heart failure patients referred to heart clinic of Alzahra hospital in shiraz,1392-93
Public title
Effect of family-centered empowerment model on life style and illness perception of patients with heart failure.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: verifying heart failure by cardiologist; age between 18-65y/o; at least in class II heart failure; tendency of patient and one of(his/her) family member to participate in this study; at least literacy(writing&reading) for patient and one of active family member; predominant to Persian language; absence of any physical and mental disease. Exclusion criteria: to become manifest of physical and mental disease; progress to class IV heart failure and become more deteriorated; lack of cooperation from patients and family members in participation of empowerment programme; absence of participation in problem-solving sessions and educational collaboration programme.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Shiraz University of Medical Sciences
Street address
seventh floor of Shiraz University of Medical Sciences and health services, next to red crescent organazation, Zand blvd
City
Shiraz
Postal code
71345-1978
Approval date
2014-05-19, 1393/02/29
Ethics committee reference number
CT- 9378-7058

Health conditions studied

1

Description of health condition studied
heart failure
ICD-10 code
195-199
ICD-10 code description
197.1

Primary outcomes

1

Description
lifestyle
Timepoint
pre intervention and 45 days after intervention
Method of measurement
questionnaire

2

Description
illness perception
Timepoint
pre intervention and 45 days after intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
lifestyle
Timepoint
pre intervention and 45 days after intervention
Method of measurement
questionnaire

2

Description
illness perception
Timepoint
pre intervention and 45 daya after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention in case group: patients and active family members attend in 5 sessions (1-2 hours) for 5 weeks and 4 stages of family-centered empowerment model is done. First step: perception of threat in 2 sessions. First session: explantation of nature, pathophysiology, ethiology and clinical manifestions of disease. Second session: training about regimen and pharmacological treatment and side effects. After every session, reevaluate previous knowledge. Second step: self-efficacy: third session: grouping problem solving Third step: self-belief: fourth session: to ask the patients that train the previous informations to active family members. Fourth step: evaluation Five session: general evaluation of patients and their accompanies.
Category
Lifestyle

2

Description
Intervention in control group: pamphlet and routine training about heart failure will receive.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
cardiac clinic of fatemeh holiness charity hospital
Full name of responsible person
Doctor Reza Mozafari
Street address
Fatemeh holiness charity hospital, blvd siboieh, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Seventh floor of Shiraz University of Medical Sciences and health services, Zand blvd
City
Shiraz
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 of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
khadijeh Rahimi Kordshouli
Position
Master science student
Other areas of specialty/work
Street address
Hazrat Fatemeh nursing and midwifery college, Namazi hospital, Namazi square, Shiraz, Fars
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3212 2633
Fax
+98 71 3212 2430
Email
khadijeh.rahimi@yahoo.co.rahimi_kh@sums.ac.ir
Web page address
http://research.sums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mahnaz Rakhshan
Position
Phd in nursing
Other areas of specialty/work
Street address
Hazrat Fatemeh nursing and midwifery college, Namazi hospital, Namazi square, Shiraz, Fars
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3212 2633
Fax
Email
mzrakhshan@ymail.commzrakhshan@gmail.com
Web page address
http://research.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Univercity of Medical Science
Full name of responsible person
Doctor Mahnaz Rakhshan
Position
Phd in nursing
Other areas of specialty/work
Street address
Hazrat Fatemeh nursing and midwifery college, Namazi hospital, Namazi square, Shiraz, Fars
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3212 2633
Fax
Email
mzrakhshan@ymail.commzrakhshan@gmail.com
Web page address
00987114674257

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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