UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038422 |
|---|---|
| Receipt number | 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 12:18:12 |
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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
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/
humas.psikologi@unpad.ac.id
Sponsor or person
Institute
Faculty of Psychology - Universitas Padjadjaran Bandung, West Java - Indonesia
Department of Clinical Psychology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043761
| Research Plan | |
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| Registered date | File name |
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