UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055797 |
|---|---|
| Receipt number | R000063765 |
| Scientific Title | Development of the collaborative care system for chronic kidney disease patients with depression: (2) Verification of the feasibility and usefulness of the care system. |
| Date of disclosure of the study information | 2024/10/09 |
| Last modified on | 2024/10/09 19:01:39 |
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Basic information
Public title
Feasibility and usefulness of the collaborative care for chronic kidney disease patients with depression
Acronym
Collaborative care for CKD patients with depression
Scientific Title
Development of the collaborative care system for chronic kidney disease patients with depression: (2) Verification of the feasibility and usefulness of the care system.
Scientific Title:Acronym
Feasibility study of the collaborative care for CKD patients with depression
Region
| Japan |
Condition
Condition
Hemodialysis patients aged 20 years and older with depressive symptoms (Patient Health Questionnaire-2 greater than or equal to 3)
Classification by specialty
| Nephrology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to develop a multidisciplinary collaborative care (MDCC) system for haemodialysis patients with depression, this study aims to test the feasibility and usefulness of this care system by practising MDCC with care managers trained by the MDCC educational programme.
Basic objectives2
Others
Basic objectives -Others
This study aims to test the feasibility of multidisciplinary collaborative care for haemodialysis patients with depression
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. participation rate in the intervention (defined as 50% or more as valid)
2. survey completion rate (defined as 80% or more valid responses to the PHQ-9 at all survey time points)
Key secondary outcomes
1. PHQ-9 (self-rated depression scale) score
2. phosphorus adsorbent adherence rate (self-rated, 0-100%) score
3. inter-dialysis weight gain (>5.7% of dry weight)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The MDCC intervention will be conducted at their own facility by care managers (healthcare professionals who work in dialysis facilities and are clinically involved with dialysis patients, such as nurses, clinical engineers, social workers, pharmacists, dietitians, or physicians) who have completed a distance learning program on mental health care for dialysis patients, The MDCC program includes (1) standard psychotherapy, primarily problem-solving therapy for depression, and (2) support for self-management (diet, fluids, medication adherence, etc.) associated with dialysis. In parallel with patient interventions, the care manager, along with care managers from several other facilities, meets once a month for 60 minutes with a psychiatrist or licensed psychologist skilled in liaison psychiatry to obtain advice on interventions. In addition to the conferences, the psychiatrist consults with the care managers as appropriate.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients aged 20 years and older with depressive symptoms (Patient Health Questionnaire-2 greater than or equal to 3)
Key exclusion criteria
1. terminal illness
2. severe hearing impairment
3. history of treatment for cardiovascular disorder (myocardial infarction, angina pectoris, stroke) in the past year
4. dementia
5. alcohol/substance use disorder
6. other patients under psychiatric treatment for psychiatric disorders
7. other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuji |
| Middle name | |
| Last name | Nishimura |
Organization
Tokyo Women's Medical University
Division name
Department of Psychiatry
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3353-8111
nishimura.katsuji@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Katsuji |
| Middle name | |
| Last name | Nishimura |
Organization
Tokyo Women's Medical University
Division name
Department of Psychiatry
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3353-8111
Homepage URL
nishimura.katsuji@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Katsuji Nishimura
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
Tel
+81-3-3353-8111
rinri.bm@twmu.ac.jp
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
| 2024 | Year | 10 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063765
