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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025906
Receipt No. R000029782
Scientific Title Effectiveness and feasibility of a disease management program strengthening good sleep and activities in people with diabetic nephropathy: A pilot study
Date of disclosure of the study information 2017/01/31
Last modified on 2019/07/09

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Basic information
Public title Effectiveness and feasibility of a disease management program strengthening good sleep and activities in people with diabetic nephropathy: A pilot study
Acronym The study of effects on a diabetic nephropathy disease management program strengthening sleep and activities
Scientific Title Effectiveness and feasibility of a disease management program strengthening good sleep and activities in people with diabetic nephropathy: A pilot study
Scientific Title:Acronym The study of effects on a diabetic nephropathy disease management program strengthening sleep and activities
Region
Japan

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

Objectives
Narrative objectives1 We carry out the program for strengthening good sleep and activities based on the previously developed disease management program for people with diabetic nephropathy and evaluate effectiveness of the improvement of diabetic nephropathy and the feasibility of the program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Physiological indicators: Weight (BMI), blood pressure, pulse rate, fasting blood glucose, HbA1c, urine protein/urine albumin, serum creatinine (eGFR), nonHDL-cholesterol, triglycerides
2. Change of the diabetic nephropathy stage
3. Onset and progression of diabetic complication and disease
4. Amount of activity
5. Sleep difficulties (description, scale scores)
6. SpO2
7. QOL
8. Feasibility: participation rate, completion rate, use of equipments and fitness, evaluation of the program, etc)
9. Behavioral indicators: quality of activities, behavior change/self-monitoring
10. Presenteeism and absennteeism
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 Implementation of a diabetic nephropathy disease management program (acquisition of self-management skills and lifestyle change, 6 month-period, combination of face-to-face interview and telephone call); Assess problems on sleep and advice coping strategies if he/she has; Recommend going to the fitness club (1/week, 12 times), assess activities and advice appropriate activities
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
74 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetic nephropathy patients at Stages 1-3 according to the diabetic guideline
1. Beneficiaries of Hiroshima-city National Health Insurance and Union National Health Insurance living in Hiroshima prefecture, and the insured of Japan Health Insurance Association, Hiroshima chapter, and National Federation of Health Insurance Societies of Hiroshima.
2. A patient was judged by his/her general physician or physician in charge of diabetic care intended to participate in this study
3. An outpatient in diabetic treatment
4. Age =>20 and =<74 years old of both sexes
5. Not participate in another clinical study
6. A patient whom can receive a written consent form
Do not consider who takes sleeping drugs and/or psychotropic drugs.
Key exclusion criteria 1. A patient was judged by the nurses (who provide the program) as unable to implement the program (such as difficulties in visiting the education site, filling in questionnaires, and measuring the sleep scale and activities by his/herself)
2. An inpatient
3. A patient at Renal Replacement Therapy (RRT)
4. A patient who has a plan for renal transplantation within 6 months
5. A patient at end stage
6. Type 1 diabetes and in case of secondary diabetes
7. Pregnant women
8. Dementia
9. Those who have behavioral problems and be considered as difficult to continue the program by his/her general physician, physician in charge of diabetic care or researcher
Target sample size 50

Research contact person
Name of lead principal investigator
1st name MICHIKO
Middle name
Last name MORIYAMA
Organization Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name Division of Nursing Science
Zip code 734-8553
Address Hiroshima
TEL 082-257-5365
Email morimich@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name MICHIKO
Middle name
Last name MORIYAMA
Organization Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name Division of Nursing Science
Zip code 734-8553
Address Hiroshima
TEL 082-257-5365
Homepage URL
Email morimich@hiroshima-u.ac.jp

Sponsor
Institute Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Hiroshima Prefecture (until March 2017)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Hiroshima Prefecture, Hiroshima City
Name of secondary funder(s) Hiroshima Prefecture

IRB Contact (For public release)
Organization Hiroshima University Research Ethics Committee
Address Kasumi 1-2-3, Minami-ku
Tel 082-257-1752
Email protocol@cimr.hiroshima-u.ac.jp

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 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 26
Results
For patients with diabetic nephropathy up to stage 3, the prevention program with enhanced sleep disorder and exercise was implemented, and statistically significant improvement was observed in BMI, HbA1c, non-HDL cholesterol, systolic blood pressure. The QOL scale, health condition score, self-management behavior were significantly improved. There was no improvement in the sleep state, but the recognition of the importance of sleep increased. We received positive evaluation from the patients.
Results date posted
2019 Year 07 Month 09 Day
Results Delayed
Delay expected
Results Delay Reason Under writing a paper
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
2017 Year 01 Month 17 Day
Date of IRB
2017 Year 01 Month 17 Day
Anticipated trial start date
2017 Year 01 Month 17 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 30 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029782

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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