UMIN-CTR Clinical Trial

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

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

"Amount of behavior modification"
:change in medication dosage (unit: optimal dosage of medication / ideal dosage of medication)

Key secondary outcomes

Study type

Interventional

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

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

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

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

Email

takura@heip.med.osaka-u.ac.jp

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

Email

takura@heip.med.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Tohoku University, Juntendo University, Kyoto University, Hyogo College Of Medicine

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

03

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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