UMIN-CTR Clinical Trial

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

Type 2 Diabetic nephropathy

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Institute of Biomedical & Health Sciences, Hiroshima University

Institute

Department

Personal name

Organization

Corporate Health Insurance Union

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2017

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2017

Year

03

Month

15

Day

Last modified on

2017

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030507