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Clinical Trial Effect of Family_Center Empowerment Model on adherence to treatment plan patients undergoing coronary artery bypass

Protocol summary

Summary
Objectives: Our goal was to study the effect of Family-Center Empowerment Model in patients undergo coronary bypass graft surgery, as a family centered intervention, on their treatment regime adherence. Design: The present study was a clinical trial, quasi-experimental, pre and post design with a comparison group was conducted with 102 patients and 102 active member patient's family from 2010 to 2011 in ICU open heart in Hospital of Tehran University of Medical Science Setting and conduct: The present study was a clinical trial that fulfilled after blocking randomized sampling, each subject were randomly assigned to experimental or control group. Participants including major eligibility criteria: All patients undergoing emergency heart surgery is not received, mental illness - mental hearths are not known and possibility of direct telephone call home patients was enrolled. After discharge the patients were hospitalized again and failed to comply with treatment programs were excluded. Intervention: For experimental group, family–center empowerment model implement with four dimensional that including: Perceived threat, self–efficacy, educational partnership and evaluation; and for control group do usual care. The research tools involves the questionnaires of demographic, adherence of therapeutic regime and empowerment dimensional information that related to patient and active member patient's family. Main outcome measures: The dimensions of patient adherence to treatment plan before the intervention at all levels in both groups was identical (0.05 <P), after the intervention in terms of experience in all aspects were more significant (0.000> p), the dimensions of adherence active member of the family health plan as well as pre -intervention levels in all groups was similar (0.05 <p) and after intervention in all aspects of were statistically significant (0.000> p) Variables: Main variables in the study included measuring levels of adherence of treatment plan and the empowering of subjects run the Family_Center Empowerment Model.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104276314N1
Registration date: 2011-06-13, 1390/03/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-13, 1390/03/23
Registrant information
Name
Soraya Nejati
Name of organization / entity
Tehran University Medical of Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 0711
Email address
nejatiso@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Science
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-02-18, 1389/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial Effect of Family_Center Empowerment Model on adherence to treatment plan patients undergoing coronary artery bypass
Public title
Family_Center Empowerment Model and treatment regime adherence
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion: Patient or his family, read and write have; patient or family can understand and have the speech in Farsi; patient undergoing emergency heart surgery is not received; client for the first time for coronary bypass surgery are hospitalized; mental illness - mental health are not known; possibility of a direct telephone call home patients exist. exclusion: Patients with cardiac problems due to reasons other than the current, or need for hospitalization and intervention is Avrzhrans so that the curriculum fails to comply; during the study or the patient's disease will progress to death; patient developed a new physical limitations that will prevent him from compliance Exercise program should be.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 102
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 ofTehran university medical science
Street address
Sixth Floor, Central Building Education, Ghods Street, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
89/د/130/980

Health conditions studied

1

Description of health condition studied
Ischemic Heart disease
ICD-10 code
I20, I21,
ICD-10 code description
Ischemic Heart disease

Primary outcomes

1

Description
Adherence to treatment regimen
Timepoint
Before the intervention and 8 weeks after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Empowerment
Timepoint
Before and one month after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
In this study, for experimental group, Family_Center Empowerment Model on four dimensions of perceived threat, self-efficacy, educational participation and evaluation was performed. In the first step ( understanding threats ) about the disease, the need for treatment ( transplant coronary artery surgery ), prognosis, condition after the operation, care during surgery and after effects of treatment failure and a short program and fourth in the second session till about nutrition, drug activity, movement, stress, tobacco discussion were, stage II Problem solving or problem-solving method group took meetings solving method group in groups of four to six persons for patients was held and the purpose of this phase increased levels efficacy of patients had stage III or participation in the training phase subjects discussed at meetings by the active member of his family had the education, stage IV or stage of the evaluation at this stage after finishing the intervention group and control group experienced adherence questionnaire Treatment plan and specific tools of empowerment was completed by subjects.
Category
Lifestyle

2

Description
Intervention control group only received routine section. Routine part of the intervention order, health and educational measures is no difference for all patients whether or control group experienced was done. In this study, the control group only received the care and the experimental group received the care and training classes on the steps of empowering family centered model was also used. In fact, in the present study, a researcher for the control group did not do any intervention and control groups experienced similar educational programs and health sector by health care providers are doing for them was used.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Soraya Nejati
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University Medical Science
Full name of responsible person
Soraya Nejati
Street address
Tehran University School of Nursing and Midwifery, East Nosrat St, Forsat St, Tohid Square, 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,Tehran University Medical Science
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
Tehran University Medical Science
Full name of responsible person
Soraya Nejati
Position
Faculty of Nursing and Midwifery Tehran
Other areas of specialty/work
Street address
Tehran University School of Nursing and Midwifery, East Nosrat St, Forsat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
nedasanaie@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Medacal Science
Full name of responsible person
Soraya Nejati
Position
Faculty of Nursing and Midwifery Tehran
Other areas of specialty/work
Street address
Tehran University School of Nursing and Midwifery, East Nosrat St, Forsat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
nedasanaie@ymail.com; nedasanaie@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Medical Science
Full name of responsible person
Soraya Nejati
Position
master of scienceFaculty of Nursing and Midwifery Tehran
Other areas of specialty/work
Street address
Tehran University School of Nursing and Midwifery, East Nosrat St, Forsat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
Fax
Email
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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