UMIN-CTR Clinical Trial

Basic information
Public title	The effect of motivational interviewing on dignity of Hemodialysis patients
Acronym	motivational interviewing effect on dignity
Scientific Title	The effect of motivational interviewing on dignity of Hemodialysis patients
Scientific Title:Acronym	motivational interviewing effect on dignity
Region	Asia(except Japan)

Condition
Condition	Patients undergoing hemodialysis
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Determining the effect of Motivational Interviewing on Inherent and social Dignity of Hemodialysis Patients
Basic objectives2	Others
Basic objectives -Others	Educational and counseling
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the dignity of hemodialysis patients before and immediately after the intervention and 4 weeks after the intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Other
Interventions/Control_1	Intervention: Motivational interview Five motivational interview sessions run in five weeks with the goal of getting to know people, engaging with emotions, changing behavior, valuing and helping to increase self-esteem. Each session lasts approximately two hours
Interventions/Control_2	control: No treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Chronic kidney disease Have been undergoing hemodialysis for at least 6 months Be literate to complete the questionnaire Able to make phone calls Have the physical and cognitive ability to attend meetings
Key exclusion criteria	There are major psychological problems (schizophrenia, paranoid disorders and major depression) in the patient that can be confirmed by a physician. Unfortunate accidents, such as the death of a first-degree relative for a patient, have occurred in the past month A person has drug abuse or is addicted Participate in a similar treatment or motivational behavior program since the onset of the disease and start hemodialysis.
Target sample size	72

Research contact person
Name of lead principal investigator	1st name Mahboobeh Middle name Last name Khajeh
Organization	Shahroud University of Medical Sciences
Division name	mahboobehkhajeh
Zip code	36147-73947
Address	7th Tir Square, Shahroud University of Medical Sciences, Shahroud, Semnan.
TEL	+982332395054(231)
Email	khajeh@shmu.ac.ir

Public contact
Name of contact person	1st name Mahboobeh Middle name Last name Khajeh
Organization	Shahroud University of Medical Sciences
Division name	mahboobehkhajeh
Zip code	36147-73947
Address	7th Tir Square, Shahroud University of Medical Sciences, Shahroud, Semnan.
TEL	+982332395054(231)
Homepage URL
Email	khajeh@shmu.ac.ir

Sponsor
Institute	Shahroud University of Medical Sciences Vice chancellor for research
Institute
Department

Funding Source
Organization	Shahroud University of Medical Sciences Vice chancellor for research
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shahroud University of Medical Sciences
Address	7th Tir Square, Shahroud University of Medical Sciences, Shahroud, Semnan.
Tel	+982332395054(231)
Email	khajeh@shmu.ac.ir

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 08 Month 01 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2020 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 29 Day
Last modified on	2020 Year 02 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045214