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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014094
Receipt No. R000016398
Scientific Title Efficacy of a disease management program focused on acquisition of self-management skills in pre-dialysis patients with diabetic nephropathy: 24 months follow-up
Date of disclosure of the study information 2014/06/01
Last modified on 2014/05/28

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Basic information
Public title Efficacy of a disease management program focused on acquisition of self-management skills in pre-dialysis patients with diabetic nephropathy: 24 months follow-up
Acronym Efficacy of a disease management program focused on acquisition of self-management skills in pre-dialysis patients with diabetic nephropathy: 24 months follow-up
Scientific Title Efficacy of a disease management program focused on acquisition of self-management skills in pre-dialysis patients with diabetic nephropathy: 24 months follow-up
Scientific Title:Acronym Efficacy of a disease management program focused on acquisition of self-management skills in pre-dialysis patients with diabetic nephropathy: 24 months follow-up
Region
Japan

Condition
Condition diabetic nephropathy
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We performed a two-group comparative study for 24 months to investigate the effect of a disease management education program based on behavior modification theory for patients with diabetic nephropathy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of patients who initiated RRT.
Key secondary outcomes 1.physiological indicators
HbA1c, serum creatinine, estimated glomerular filtration rate, blood urea nitrogen, hemoglobin, total protein, albumin, potassium, inorganic phosphate, non high-density lipoprotein cholesterol, blood pressure, body mass index
2.psychological indicators
the self-efficacy scale of health behavior in patients with chronic disease, the World Health Organization Quality of Life instrument, Japanese version scale
3.process indicators
the percentage of days per month that subjects performed the following self-management behaviors
A.dietary and exercise target behaviors B.self-monitoring of blood pressure, body weight, and blood glucose levels
C.medication complied with the instructions of their physician

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
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 The objectives of this program were for the subjects to acquire self-management skills. Prochaska et al. stated that behavior modification is maintained after 6 months of fulfilment. To provide skills for managing seasonal events, the duration of the program was set at 12 months.
Subject education was conducted via face-to-face interviews for every 2 weeks from enrollment to 2nd month at the subject's home or at a collaborating research center and phone calls for every month from the 3rd to 12th month. Education focused on diet, drug therapy, and exercise/rest balance etc. Materials used for education included booklets created by the researchers based on the CKD and Diabetes evidence-based clinical guidelines, the ethnographical field study done by us in order to identify patients' view points of self-management, and expert opinions of nephrologists and endocrinologists. The development of the program aims for the acquisition of knowledge and skills that patients can use, and is based on "andragogy" where patients proactively learn from their own experiences with support to enhance self-efficacy, as well as the incorporation of behavior modification theories such as the transtheoretical model, motivation interviewing method, and social support theory.
In cooperation with the primary care physician, target values of blood pressure, weight, and laboratory parameters were verified, as well as instructions for diet and exercise. Physicians received monthly progress reports from the nurses, while abnormal data or symptoms were reported immediately.
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
75 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria were an estimated glomerular filtration rate between 15 to 59 mL/min/1.73 m2 and age from 20 to 74 years.
Key exclusion criteria Exclusion criteria were current RRT, cognitively impaired or mental disorders, or pregnancy.
Target sample size 50

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 Kana Kazawa
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 082-257-5382
Homepage URL
Email kanak1016@gmail.com

Sponsor
Institute Division of Nursing Science, Institute of Biomedical & Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization Division of Nursing Science, Institute of Biomedical & Health Sciences, Hiroshima University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 広島大学(広島県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of the 31 subjects enrolled in each group, 26 subjects in the intervention group and 27 subjects in the control group were analyzed after excluding drop-outs. During the study period, 0 and 2 subjects in the intervention group and the control group started RRT, respectively. In the intervention group, renal function maintained, while significant worsening was observed in the control group. Hemoglobin A1c improved in the intervention group, on the contrary became significantly worse in the control group. In the intervention group, all process indicators of behavior modification increased significantly after our intervention.
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
2010 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 18 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 06 Month 30 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 28 Day
Last modified on
2014 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016398

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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