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The effect of empowerment program based on BASNEF model on general health and self-efficacy of hemodialysis patients

Protocol summary

Summary
Objective: To determine the effect of empowerment program based on the BASNEF model on general health and self-efficacy of hemodialysis patients. Study design: Clinical trial, randomized, single-blind. The inclusion Main criteria: Chronic hemodialysis patients, aged 18 to 65 years and a willingness to Participating in research; the lack of history of known psychological problems and Known cognitive problems including Alzheimer's disease, stroke and transient ischemic attack. The exclusion main criteria: dissatisfaction with continuation of cooperation with the research, outbreak debilitating complications and death in studying subjects during the study. Sample size: 70 hemodialysis patients. Intervention: For intervention group patients, BASNEF-based empowerment program (in the field of Problems, feelings, opinions and thoughts of patients regarding hemodialysis and their lives, importance of hemodialysis, recognizing complications and their prevention and treatment, correct style of life in the fields of nutrition, exercise, self-care, anxiety and stress management, coping with negative attitudes, cognitive restructuring and patient's enabling factors) is performed by researchers. Intervention method so that Patients in groups (least 8 people and maximum 15 people) in 8 sessions 60 minutes (over 4 weeks and two days in a week), in a hemodialysis department in a place separate from hospitalized part of other patients, will participate. Patients in the control group underwent routine cares and educations and them will gave the hemodialysis patients special educational pamphlet. Intervention time: two months. Study outcomes: Increased levels of general health and self-efficacy of hemodialysis patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017022514086N10
Registration date: 2017-05-06, 1396/02/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment program based on BASNEF model on general health and self-efficacy of hemodialysis patients
Public title
The effect of empowerment program based on BASNEF model on general health and self-efficacy of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients treated with chronic hemodialysis according to specialist diagnosis. 2. Willingness to participate in research. 3. Aged 18 to 65 years. 4. A history of well-known mental problems and kidney transplant is not. 5. Known cognitive problems including Alzheimer's disease, stroke, transient ischemic attack and hearing and vision loss to the extent that they cannot read or write; not suffered. 6. Physical and mental ability have to participate in empowerment meetings and be able to talk. 7. The caregiver is an important person for studying person and trust and confidence family and relatives his/her that directly involved in patient care. Exclusion criteria: 1. Dissatisfaction with continuation of cooperation with the study for any reason and at any phase 2. The absence in two or more sessions in the research program. 3. Outbreak debilitating complications of the disease. 4. Studying person died during the study.
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Vice Chancellor of Research & Technology, Kashan University of Medical Sciences, 5th km of Ravandi Ghotb Blvd, Kashan
City
Kashan
Postal code
8715988141
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.KAUMS.REC.1395.145

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
General health
Timepoint
At baseline and a week after the last session implantation in the intervention group and after a month of the start of the study in the control group
Method of measurement
Goldberg's General Health Questionnaire‏

2

Description
self-efficacy
Timepoint
At baseline and a week after the last session implantation in the intervention group and after a month of the start of the study in the control group
Method of measurement
Sherer's General Self-Efficacy Scale

Secondary outcomes

empty

Intervention groups

1

Description
For intervention group patient, BASNEF-based empowerment program is performed by researchers. Intervention method so that Patients in groups (least 8 people and maximum 15 people) in 8 sessions 60 minutes (over 4 weeks and two days in a week), in a hemodialysis department in a place separate from hospitalized part of other patients, will participate. During the meeting's the program, about Problems, feelings, opinions and thoughts of patients regarding hemodialysis and their lives, the importance of hemodialysis, recognizing complications and their prevention and treatment, the correct style of life in the fields of nutrition, exercise, self-care, anxiety and stress management, coping with negative attitudes, cognitive restructuring and patient's enabling factors, as group with lecture, group discussion and questions and answers methods will be discussed. According BASNEF model, in addition to the investigator and the patient, a meeting attended by treatment team members (Physicians, nurses and dietitian) and a meeting with a member of the patient family, will be held. In addition, the educational content in the form of a pamphlet available patient Family member will be, so that the education offered continuing more.
Category
Behavior

2

Description
Patients in the control group underwent routine cares and educations and them will gave the hemodialysis patients special educational pamphlet.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhavan Hospital
Full name of responsible person
Zahra Saeidnejad
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences, Vice Chancellor of Research & Technology
Full name of responsible person
Gholam Ali Hamidi
Street address
Vice Chancellor of Research & Technology, Kashan University of Medical Sciences, 5th km of Ravandi Ghotb Blvd, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences, Vice Chancellor of Research & Technology
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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
MSN, PhD Student in Nursing/ Instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kashan University of Medical Sciences, 5th km of Ravandi Ghotb Blvd, Kashan
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
Email
aghajani1362@yahoo.com; aghajani_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
MSN, PhD Student in Nursing/ Instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kashan University of Medical Sciences, 5th km of Ravandi Ghotb Blvd, Kashan
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
Email
aghajani1362@yahoo.com; aghajani_m@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
MSN, PhD Student in Nursing/ Instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kashan University of Medical Sciences, 5th km of Ravandi Ghotb Blvd, Kashan
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
Email
aghajani1362@yahoo.com; aghajani_m@kaums.ac.ir
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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