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Effectiveness of Motivational Interviewing on treatment adherence and quality of life on Hemodialysis patients in Hajar hospital of Shahrekord

Protocol summary

Summary
(1) Objectives: This study aimed to evaluate the effectiveness of motivational interviewing on treatment adherence and quality of life of dialysis patients. (2) Design: The study is experimental research, using pre-test and post-test with control group. (3) Setting and conduct: The population consisted of all dialysis patients who are admitted to the Hajar Hospital of Shahrekord in 2013. After obtaining the administrative permission and checking all hemodialysis patients, the appropriate samples will be selected . (4) Participants including major eligibility criteria: A Sample of 30 patients of volunteers will be selected who passed at least 3 months of having chronic kidney disease and requiring dialysis and have no important disease except chronic kidney disease and didn't receive other psychological treatments. Patients, who missed more than one session of treatment, will be excluding. Then these 30 patients will be dividing randomly into two groups of 15 people. And finally, they will be dividing randomly into two experimental groups and the control group. (5) Intervention: The experimental group receives a motivational interviewing for 5 weekly sessions, while the control group will not receive any kind of intervention. (6) Main outcome measures variables: Main variables are quality of life, which measured by Persian form of quality of life questionnaire for patients on dialysis (KDQOL - SF ™ 1/3). The second variable is treatment adherence that including: calcium, phosphorus, creatinine, hemoglobin, sodium, potassium and interdialytic weight gain. These variables records of the case patients before and after the the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014110119774N1
Registration date: 2014-12-26, 1393/10/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-26, 1393/10/05
Registrant information
Name
Fereshte Alidoust Ghahfarokhi
Name of organization / entity
Semnan university
Country
Iran (Islamic Republic of)
Phone
+98 23 3362 4250
Email address
f.alidoust@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Motivational Interviewing on treatment adherence and quality of life on Hemodialysis patients in Hajar hospital of Shahrekord
Public title
Effectiveness of Motivational Interviewing on treatment adherence and quality of life on Dialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
The main inclusion criteria to the study: • Passed at least 3 months of having chronic kidney disease and requiring dialysis; • Willing and informed consent to participate in research; • No important disease except chronic kidney disease; • No other psychological treatment. The main Exclusion criteria of study: • Missing more than one session of treatment; • Other physical disease during the implementation of motivational interviewing; • Having a mental illness; • Increasing the patient's condition so that the patient could not attend the meeting; • Kidney transplant.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not 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 of Semnan university
Street address
Zip code: 35131- 19111, Faculty of Psychology and Educational Sciences, Mahdishahr, Semnan.
City
Mahdishahr
Postal code
35131-19111
Approval date
2013-11-26, 1392/09/05
Ethics committee reference number
98/92/825

Health conditions studied

1

Description of health condition studied
chronic kidny disease
ICD-10 code
N18.5
ICD-10 code description
Chronic uraemia End stage kidney disease:•on dialysis

Primary outcomes

1

Description
quality of life
Timepoint
after intervention, befor intervention
Method of measurement
Persian form of quality of life questionnaire for dialysis patients (KDQOL - SF ™ 1/3)

2

Description
Inter-dialysis weight change
Timepoint
after intervention, befor intervention
Method of measurement
Recorde of the case patient

3

Description
Serum’s potassium, Serum’s phosphorus,srum's sodium, serum's calsium, Creatinine and hemoglobin
Timepoint
after intervention, befor intervention
Method of measurement
Blood expriment

Secondary outcomes

1

Description
depression
Timepoint
befor intervention, after invention
Method of measurement
Beck depression inventory

2

Description
Hopefulness
Timepoint
after invention, befor invention
Method of measurement
Snyder Hopefulness Questionnair

Intervention groups

1

Description
Experimental group: In this study, motivational interviewing in the experimental group runs in accordance with the principles of Miller and Rollnick in the fifth sessions. Contents of the Motivational interviewing session: • First session (dating): A group norms and processes, facilitates the philosophy, practice of freedom, the exercise of Dimensions of behavior influence, the exercise of change cycle assessment of commitment and confidence. • Second session (emotion): Feelings Practice identifying, practicing and perfecting the exercise of influence dimension and emotional dimension and homework. • The third session (positive and negative aspects of behavior and change): Practice of brainstorming of Short-term and long-term profit and losses, Practice of complete table of the positive and negative aspects, describe and Practice of corrective options and alternatives one. • Fourth session (values): Definition of values, Practice of identifying and prioritizing notch values, practice to define values and value-behavior consistency. • Fifth session (closing Landscape): Summarizing and concluding of previous training Sessions in a Landscape practice and preparation for the start of behavior change programs.
Category
Treatment - Other

2

Description
Control group: The control group received no intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital of Shahrekord
Full name of responsible person
Ali Momeny MD
Street address
Department of Nephrology, Hajar Hospital, Shahrekord University of Medical Sciences
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Semnan university
Full name of responsible person
Ali Mohammad Rezaei Ph.D.
Street address
Vice chancellor for research, Faculty of Psychology and Educational Sciences, Semnan University, Semnan
City
Semnan
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, Semnan university
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
Semnan university
Full name of responsible person
Fereshte Alidoust Ghahfarokhi
Position
Clinical Psychology student (M.A)
Other areas of specialty/work
Street address
Faculty of Psychology and Educational Sciences, Semnan University, Semnan
City
Mahdishhr
Postal code
35131-19111
Phone
+98 23 3362 4250
Fax
Email
f.alidoust@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan university
Full name of responsible person
Fereshte Alidoust Ghahfarokhi
Position
clinical psychology (MA)
Other areas of specialty/work
Street address
Faculty of Psychology and Educational Sciences, MahdishahrSemnan
City
Mahdishahr
Postal code
35131-19111
Phone
+98 23 3362 4250
Fax
Email
f.alidoust@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan university
Full name of responsible person
Fereshte Alidoust Ghahfarokhi
Position
Clinical Psychology student (M.A)
Other areas of specialty/work
Street address
Faculty of Psychology and Educational Sciences, Mahdishahr, Semnan
City
Mahdishahr
Postal code
35131-19111
Phone
+98 23 3362 4250
Fax
Email
f.alidoust@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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