UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of feasibility and effects of the distant interview program for preventing the progression of diabetic nephropathy
Title of the study (Brief title)	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	Michiko Moriyama
Organization	Institute of Biomedical & Health Sciences, Hiroshima University
Division name	Division of Nursing Science
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	Michiko Moriyama
Organization	Institute of Biomedical & Health Sciences, Hiroshima University
Division name	Division of Nursing Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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