UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038422
Receipt No. R000043761
Scientific Title Effectiveness Cognitive Behavior Therapy (CBT) to improves adherence to fluid restriction in End Stage Renal Disease (ESRD) patients undergoing hemodialysis : Randomized Controlled Trial
Date of disclosure of the study information 2019/10/31
Last modified on 2019/10/29 (Ver. 1)

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Basic information
Public title Effectiveness Cognitive Behavior Therapy (CBT) to improves adherence to fluid restriction in End Stage Renal Disease (ESRD) patients undergoing hemodialysis : Randomized Controlled Trial
Acronym The use Cognitive Behavior Therapy (CBT) in End Stage Renal Disease (ESRD) patients undergoing hemodialysis
Scientific Title Effectiveness Cognitive Behavior Therapy (CBT) to improves adherence to fluid restriction in End Stage Renal Disease (ESRD) patients undergoing hemodialysis : Randomized Controlled Trial
Scientific Title:Acronym The use Cognitive Behavior Therapy (CBT) in End Stage Renal Disease (ESRD) patients undergoing hemodialysis
Region
Asia(except Japan)

Condition
Condition End Stage Renal Disease (ESRD) patients undergoing hemodialysis
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study of effectiveness Cognitive Behavior Therapy (CBT) to improves adherence to fluid restriction in End Stage Renal Disease (ESRD) patients undergoing hemodialysis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes improves adherence to fluid restriction
Key secondary outcomes improves self efficacy, quality of life and decrease anxiety and depression level

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Cognitive Behavioral Therapy for 6 weeks and every therapy session last for 60 minutes.
Interventions/Control_2 Patient's in control group received no therapy at all.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Individual diagnosed with ESRD by a nephrologist, have non-adherence problem to diet restriction (recommended from nephrologist and nurse; when patients are unable to reach dry weight at the very least in the last five HD sessions, aged more than 18 years, undergoing hemodialysis for more than 6 months, and have an adequate command of the Indonesian language.
Key exclusion criteria Patients who had a mental illness, disabilities, speech-hearing problems, and memory loss were excluded
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kustimah
Middle name
Last name Kustimah
Organization Faculty of Psychology, Universitas Padjadjaran
Division name Department of Clinical Psychology
Zip code 45363
Address Jl. Raya Bandung-Sumedang Km.21 Jatinangor- Sumedang- Jawa Barat- Indonesia
TEL +62227794126
Email kustimah@unpad.ac.id

Public contact
Name of contact person
1st name Kustimah
Middle name
Last name Kustimah
Organization Faculty of Psychology, Universitas Padjadjaran
Division name Department of Clinical Psychology
Zip code 45363
Address Jl. Raya Bandung-Sumedang Km.21 Jatinangor- Sumedang- Jawa Barat- Indonesia
TEL +62227794126
Homepage URL http://psikologi.unpad.ac.id/
Email humas.psikologi@unpad.ac.id

Sponsor
Institute Faculty of Psychology - Universitas Padjadjaran Bandung, West Java - Indonesia

Department of Clinical Psychology
Institute
Department

Funding Source
Organization Indonesian Endowment Fund for Education/ Lembaga Pengelola Dana Pendidikan (LPDP)
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Indonesia

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

IRB Contact (For public release)
Organization Komisi Etik Penelitian Universitas Padjajaran
Address Jl. Prof. Eijkman No. 38 Bandung
Tel +62222038697
Email etik.unpad@gmail.com

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 RS Al Islam Bandung
Jl. Soekarno-Hatta No. 644 RT. 001 RW. 001 Kel. Manjahlega Kec. Rancasari-Bandung
40286- Indonesia

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 31 Day

Related information
URL releasing protocol https://benthamopen.com/FULLTEXT/TOPSYJ-12-141
Publication of results Published

Result
URL related to results and publications https://benthamopen.com/FULLTEXT/TOPSYJ-12-141
Number of participants that the trial has enrolled 31
Results 
CBT enhance adherence to fluid restriction, self-efficacy and QoL and decreasing level of anxiety and depression in End Stage Renal Disease patients undergoing Hemodialysis
Results date posted
2019 Year 10 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Adult ESRD patients who have non-adherence problem to diet restriction, undergoing hemodialysis for more than 6 months and have an adequate command of the Indonesian language.
Participant flow 
First, we assessed the total ESRD patients who eligible for this study (n=230). There were 184 patients excluded from the current study because (1) did not meet inclusion criteria (n=150), (2) declined the opportunity to participate (n=11) and (3) unable to participate (n=23). Forty-six of the original participants blinded to intervention randomization (unaware if they had been randomized to CBT or control group). Both intervention and control group have 23 participants. In intervention group, nine participants dropped out because of deceased (n=5), ill health (n=3) and refused to continue the therapy (n=1). While in control group, six participants dropped out because deceased (n=2) and ill health (n=4). Finally, the intervention and control group comprised of 14 and 17 participants, respectively.
Adverse events 
However, participants may experience tiredness after the therapy both physically and psychologically. Some of the information presented or asked by the therapist may be distressing or uncomfortable, in which case additional support may be arranged. Information will be kept confidential and each participant will be anonymous.
Outcome measures 
IDWG, anxiety, depression, self-efficacy and quality of life.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
2018 Year 01 Month 04 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2018 Year 05 Month 01 Day
Date of closure to data entry
2018 Year 05 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 05 Day
Date analysis concluded
2018 Year 08 Month 05 Day

Other
Other related information The data support the improvement of self-efficacy and QoL and decreasing level of anxiety and depression in End Stage Renal Disease patients undergoing Hemodialysis

Management information
Registered date
2019 Year 10 Month 29 Day
Last modified on
2019 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043761