UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039644
Receipt number R000045214
Scientific Title The effect of motivational interviewing on dignity of Hemodialysis patients
Date of disclosure of the study information 2020/12/28
Last modified on 2020/02/29 05:25:48

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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 or person

Institute

Shahroud University of Medical Sciences
Vice chancellor for research

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045214


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name