Protocol summary

Summary
The aim of this study is investigate the effect of family centered empowerment model on the treatment adherence in hemodialysis patients. Eighty-four patients treated with hemodialysis for at least six months and three hemodialysis sessions per week that have inclusion criteria, participate in this study. In case of peritoneal dialysis, transplantation or death, patient exclude of study. This clinical trial include two groups (42 patients in intervention group & 42 patients in control group) and is single (Expert statistics) blind. Before intervention, the related forms and questionnaires will complete. In the intervention stage, for family active member in intervention group, 5-7 empowerment sessions will done on based family centered empowerment model with four step contain perceived threat, self -efficacy, self-esteem and evaluation. First step will be done for increase perceived intensity and perceived sensivity. The aim to second step or self-efficacy through group problem solving is to understand the family active member from the problem and problem solving process. In the third step or self-esteem through educational participation, discussed contents in sessions by family active member will be trained to patient. Evaluation step contains process and final evaluation. In process evaluation, during sessions, family active member is evaluated for perceived threat, self -efficacy and self-esteem. Furthermore, after intervention, empowerment evaluation questionnaire will complete by patient and family active member. Final evaluation will be done one month after the completion of the empowerment evaluation questionnaire for investigate effectiveness model and with completion treatment adherence questionnaire and checklist for record laboratory and clinical indicators in both groups. The control group receives just routine interventions and after final evaluation, pamphlet and booklet will be available for them.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102824758N1
Registration date: 2015-11-29, 1394/09/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-29, 1394/09/08
Registrant information
Name
Akram Tavakoli
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4444 6070
Email address
tavakolia91@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
sabzevar university of medical sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2015-12-11, 1394/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Family-Centered Empowerment Model on the Treatment Adherence in Hemodialysis Patients
Public title
The effect of family empowerment on the treatment adherence in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for patient and family active member: Willing to participate in the study; Age range 18 years and over; Reading and writing ability; Listening and speaking ability and acceptable consciousness to communicate; Lack of mental illness and cognitive impairment; Lack of participate in formal training sessions in the field of empowerment and treatment adherence at the same time; The weak or moderate score of empowerment evaluation questionnaire Inclusion criteria for patient: Suffering of chronic renal failure and treatment with hemodialysis for at least six months; Three hemodialysis sessions in week and each session lasting 3-4 hours; Lack of other chronic disease; The weak or moderate score of treatment adherence questionnaire; Lack of physical limitations for self-care Exclusion criteria for patient: Kidney transplant; Peritoneal dialysis or death during the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
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
Ethics Committee of Sabzevar University of Medical Sciences
Street address
School of Nursing and Midwifery, Next to The Police Station to Shahrud Road, Sabzevar
City
Sabzevar
Postal code
Approval date
2015-08-16, 1394/05/25
Ethics committee reference number
IR.MEDSAB.1394.52

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis

Primary outcomes

1

Description
Treatment adherence
Timepoint
Before intervention- One month after the completion of the empowerment evaluation questionnaire
Method of measurement
Researcher made questionnaire

2

Description
Empowerment
Timepoint
Before intervention- One week after intervention
Method of measurement
Researcher made questionnaire

Secondary outcomes

1

Description
Laboratory and clinical indicators
Timepoint
Before intervention- After intervention
Method of measurement
Checklist for record laboratory and clinical indicators

Intervention groups

1

Description
Intervention group: Family active member participate in 5-7 empowerment sessions in four steps: Perceived threat, self- efficacy, Self-esteem and evaluation.
Category
Behavior

2

Description
Control group: Get routine interventions in hemodialysis part and recive pamphlet and booklet after final evaluation.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Street address
Nuclear Martyrs Blvd, Sabzevar
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Sabzevar University of Medical Sciences
Full name of responsible person
Mr. Moosa Reza Tadayonfar
Street address
School of Nursing and Midwifery, Next To The Police Station to Shahrud Road, Sabzevar
City
Sabzevar
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 Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Akram Tavakoli
Position
Critical Care Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next To The Police Station to Shahrud Road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
TavakoliA91@medsab.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mr. Mehdi Jafarzade
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next To The Police Station to Shahrud Road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
mjafarzade4@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Akram Tavakoli
Position
Critical Care Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next To The Police Station to Shahrud Road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
TavakoliA91@medsab.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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