UMIN-CTR Clinical Trial

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	doi: 10.1136/bmjopen-2020-045783
Publication of results	Published

Result
URL related to results and publications	doi: 10.1136/bmjopen-2020-045783
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
Results Delay Reason
Date of the first journal publication of results	2021 Year 09 Month 21 Day
Baseline Characteristics	Of 26 patients, 17 were male (65.4%), and the mean age was 65.7 (SD 6.0) years. Of the 24 participants, 15(62.5%) were classified as having sleep disorders.
Participant flow	Twenty-nine participants were introduced. Among them, 26 met the eligibility criteria and were enrolled. Two participants dropped out right after enrolment. Therefore, only 24 participants completed the 6-month programme.
Adverse events	None
Outcome measures	To examine programme efficacy, baseline conditions were compared with outcomes during the 3rd and 6th months of intervention. Physiological indicators (BMI, BP, eGFR, triglyceride, non-HDL, HbA1c), Number of steps per day, QOL, quality of sleep, behavior change
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 03 Month 09 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	2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 30 Day
Last modified on	2021 Year 10 Month 19 Day

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