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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026568
Receipt No. R000030507
Scientific Title Evaluation of feasibility and effects of the distant interview program for preventing the progression of diabetic nephropathy
Date of disclosure of the study information 2017/03/15
Last modified on 2017/03/15

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Basic information
Public title Evaluation of feasibility and effects of the distant interview program for preventing the progression of diabetic nephropathy
Acronym Evaluation of feasibility and effects of the distant interview program for patients with diabetic nephropathy
Scientific Title Evaluation of feasibility and effects of the distant interview program for preventing the progression of diabetic nephropathy
Scientific Title:Acronym Evaluation of feasibility and effects of the distant interview program for patients with diabetic nephropathy
Region
Japan

Condition
Condition Type 2 Diabetic nephropathy
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of the distant interview program for patients with diabetic nephropathy using an ICT application. The first objective is pre and post comparison between intervention and control groups. The second one is to examine the feasibility of the distant interview program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Self-management indicators: A 5-points scale based on the model of behavioral change suggested by Prochaska (1983) is developed to evaluate self-management behavior for diet, excercise, medication and self-monitoring.
Key secondary outcomes 1) Physical indicators: Serum creatinine, estimated glomerular filtration rate, blood urea nitrogen, hemoglobin, total protein, albumin, potassium, inorganic phosphate, HbA1c, non-high-density lipoprotein cholesterol, blood pressure, body mass index, and urine protein. The change of CKD stage, number of participants initiating dialysis, and number of participants with cardiovascular events were used as parameters.
2) Psychological indicators: The self-efficacy scale of health behavior in patients with chronic disease and the mean values of 2 items for global QOL in the World Health Organization Quality of Life (WHO-QOL26) scale, Japanese version.
3) Feasibility: Trusting the nurse, Motivation for behavioral change, Correctness of information, Clarity of images or sound (distance interview only), Operability of the device and interview method (distance interview only), Protection of privacy.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The program implemented by distance interviews using a tablet computer and intermittent telephone calls. In Months 1 to 3, individual distance interviews about 1 hour long were held once a month using a tablet computer and biweekly follow up education calls were given via telephone for about 30 minutes. Education was provided based on the evidence based clinical guidelines for Diabetes and for CKD. The CKD stage was assessed at the initial interview based on laboratory data, while risk factors were identified based on laboratory data, treatment, and information obtained from physical examination and evaluation regarding the lifestyle. The nurses explained the pathology and management of diabetic nephropathy and discussed the goals for improvement of their lifestyles. Subsequently, each participant measured the blood pressure, body weight, and blood glucose level at home, recorded the results in a self monitoring notebook, took medications, periodically visited the clinic, and followed diet and exercise therapy as discussed to achieve the goals defined with assistance from the nurses. The results of implementation were reported to the nurses every month. The tablet with an application for instructions was delivered to the participants by postal mail. The guidebook was included in the app, but a paper version was also delivered to the participants by mail together with the self monitoring notebook and foot care monofilament.
Interventions/Control_2 The program implemented by face to face interviews and intermittent telephone calls. In Months 1 to 3, individual face to face interviews about 1 hour long were held once a month in a private room at the workplace or at a public facility where the privacy of the participant could be protected, and biweekly follow up education calls were given via telephone for about 30 minutes. The guidebook, the self monitoring notebook, and monofilament for foot care were delivered by mail.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Participants are employees of A company and fall the following:
[1] Urine protein 2+ or higher, or urine protein 1+ and HbA1c 7.0% and over (FBS 130 mg/dL and over) at a health check in 2013 (a special check for individuals aged 40 years or older) and [2] Diagnosed as type 2 diabetes.
Key exclusion criteria Exclusion criteria are the following: type 1 diabetes or gestational diabetes, initiated to dialysis, scheduled for renal transplantation in the near future, undergoing treatment for cancer, terminal illness, cognitive impairment, and mental disorders.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiko Moriyama
Organization Institute of Biomedical & Health Sciences, Hiroshima University
Division name Division of Nursing Science
Zip code
Address Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL 082-257-5365
Email morimich@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiko Moriyama
Organization Institute of Biomedical & Health Sciences, Hiroshima University
Division name Division of Nursing Science
Zip code
Address Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL 082-257-5365
Homepage URL
Email morimich@hiroshima-u.ac.jp

Sponsor
Institute Institute of Biomedical & Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization Corporate Health Insurance Union
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 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
2017 Year 03 Month 15 Day
Last modified on
2017 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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