UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021523 |
|---|---|
| Receipt number | R000024821 |
| Scientific Title | Health promotion research with methods of behavioral economics |
| Date of disclosure of the study information | 2016/03/17 |
| Last modified on | 2016/03/26 19:02:33 |
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Basic information
Public title
Health promotion research with methods of behavioral economics
Acronym
Health economy research of adherence
Scientific Title
Health promotion research with methods of behavioral economics
Scientific Title:Acronym
Health economy research of adherence
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a new theory regarding incentives to modify behavior through structuring of patient behavior using behavioral economics which discusses issues overlapping with limitations of health promotion practice.
Basic objectives2
Others
Basic objectives -Others
1) Studies of patient behavior modification by applying prospect theory: to evaluate the theory of promoting improvement in adherence to medical treatment for renal failure in patients with cardiovascular diseases and diabetes by focusing on the endowment effect and status quo biases.
2) Study on patient behavior modification by using heuristics: to evaluate and confirm the theory of promoting improvement in health behavior and adherence to medical treatment for renal failure in outpatients with cardiovascular disease and diabetes by focusing on the capacity for adaptation and anchoring.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
"Amount of behavior modification"
:change in medication dosage (unit: optimal dosage of medication / ideal dosage of medication)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Health Consultation(Medication Teaching, Exercising Guidance, Nutrition Guidance)
- Intervention period: One month (baseline)
- Intervention frequency: Four times a month (a standard)
- Term for evaluation: Post six months (a standard)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This study includes patients less than 70 years of age with chronic and end-stage renal failure taking phosphate binders, such as Fosrenol, sevelamer, and calcium carbonate.
1) Patients with chronic and end-stage renal failure
2) Patients at least 20 but less than 70 years of age
3) Patients able to visit the hospital regularly
4) Patients without serious systemic diseases or functional disorders
5) Sex: male or female
6) Patients taking a phosphate binder
Key exclusion criteria
The following are criteria for exclusion from this study in terms of the reliability of assessing the study endpoint.
1) Clinical findings
A. Mental disorder
B. Malignant tumors
C. A history of concomitant active infection
D. Poorly controlled diabetes
2) Others
- Patients with marked restriction of activities of daily living (severity)
- Participants in a clinical study/ trial
In addition, patients judged to be ineligible by the attending physicians are to be excluded from this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Takura |
Organization
Osaka University
Division name
Graduate School of Medicine
Zip code
Address
2-2, Yamadaoka Suita-shi, Osaka
TEL
06-6879-3401
takura@heip.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Takura |
Organization
Osaka University
Division name
Graduate School of Medicine
Zip code
Address
2-2, Yamadaoka Suita-shi, Osaka
TEL
06-6879-3401
Homepage URL
takura@heip.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tohoku University, Juntendo University, Kyoto University, Hyogo College Of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学付属病院（宮城）、順天堂大学病院（東京都）、兵庫医科大学病院（兵庫）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 17 | 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
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 17 | Day |
Last modified on
| 2016 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024821
