UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059317 |
|---|---|
| Receipt number | R000067848 |
| Scientific Title | Development and Evaluation of a Remote Support Program Based on the Self-Determination Theory Healthcare Model for Outpatients Undergoing Hemodialysis |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/07 15:55:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and Evaluation of a Remote Support Program Based on the Self-Determination Theory Healthcare Model for Outpatients Undergoing Hemodialysis
Acronym
SDT-MI for HD
Scientific Title
Development and Evaluation of a Remote Support Program Based on the Self-Determination Theory Healthcare Model for Outpatients Undergoing Hemodialysis
Scientific Title:Acronym
SDT-MI for HD
Region
| Japan |
Condition
Condition
End-stage renal disease (outpatients receiving hemodialysis)
Classification by specialty
| Nephrology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a remote support program to implement online motivational interviewing based on the framework of the Self-Determination Theory Healthcare Model for outpatients receiving hemodialysis at dialysis facilities, and to conduct an interventional study to evaluate its effects on optimizing interdialytic weight gain, improving self-management behaviors, and enhancing quality of life (QOL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
nterdialytic weight gain (IDWG).
The mean IDWG will be measured at baseline, immediately after the intervention, 3 months, and 6 months after completion, and changes over time will be evaluated.
Key secondary outcomes
1. Psychological variables based on the Self-Determination Theory constructs
Assessed using the Japanese version of the Self-Determination Theory measurement scales (Yamamoto et al., 2009) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention.
Health Care Climate Questionnaire (HCCQ): one-factor, 6-item scale; 7-point Likert scale (1 = not at all true - 7 = very true).
Treatment Self-Regulation Questionnaire (TSRQ): three-factor, 15-item scale; 7-point Likert scale (1 = not at all true - 7 = very true).
Perceived Competence Scale (PCS): one-factor, 4-item scale; 7-point Likert scale (1 = not at all true - 7 = very true).
2. Self-management behavior
Assessed using the Hemodialysis Self-Management Instrument (HDSMI, Japanese version; Nozawa et al., 2007) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention.
3. Health-related quality of life (HR-QOL)
Assessed using the Japanese version of the SF-8 Health Survey (Fukuhara et al., 2005) at baseline, immediately after the intervention, 3 months, and 6 months after the intervention.
The SF-8 consists of eight subscales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and yields Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
As "educational material-based knowledge provision," participants will receive a pamphlet summarizing key points necessary for appropriate control of interdialytic weight gain, which will be distributed and explained in person.
Subsequently, five online counseling sessions (approximately 30 minutes each) will be conducted based on the framework of the Self-Determination Theory healthcare model, using motivational interviewing (MI) techniques.
During each session, a goal-setting sheet that participants can complete themselves will be used as supplementary material and shared on screen to facilitate the following steps:
(1) clarification of personal values, (2) collaborative setting of specific behavioral goals, (3) review of progress and adjustment of plans, and (4) resetting of goals.
These processes aim to enhance intrinsic motivation and promote behavioral change.
Interventions/Control_2
Distribute a pamphlet on appropriate control of interdialytic weight gain and provide only educational material-based knowledge provision. No online interviews will be conducted.
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
1. Outpatients receiving maintenance hemodialysis (HD) three times per week at participating facilities
2. Patients who have been on dialysis for more than 6 months
3. Mean interdialytic weight gain over the past 4 weeks of >=4% after one non-dialysis day or >=6% after two non-dialysis days
4. Able to operate a smartphone
Key exclusion criteria
1.Cognitive impairment
2.Severe comorbidities such as significant visual impairment, lower limb amputation, cerebrovascular disease, heart failure, or malignancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tamako |
| Middle name | |
| Last name | Yonezawa |
Organization
Kobe Women's University
Division name
Doctoral Program, Graduate School of Nursing
Zip code
650-0046
Address
4-7-2 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo 650-0046, Japan
TEL
078-303-4705
k5820103@suma.kobe-wu.ac.jp
Public contact
Name of contact person
| 1st name | Tamako |
| Middle name | |
| Last name | Yonezawa |
Organization
Kobe Women's University
Division name
Doctoral Program, Graduate School of Nursing
Zip code
650-0046
Address
4-7-2 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo 650-0046, Japan
TEL
078-303-4705
Homepage URL
k5820103@suma.kobe-wu.ac.jp
Sponsor or person
Institute
Kobe Women's University
Institute
Department
Personal name
Tamako Yonezawa
Funding Source
Organization
Takarazuka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Kobe Women's University and Kobe Women's Junior College
Address
4-7-2 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo 650-0046, Japan
Tel
078-303-4705
info@kobe-wu.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
| 2025 | Year | 10 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067848
