UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025906 |
|---|---|
| Receipt number | 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 | 2021/10/19 09:59:57 |
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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
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
morimich@hiroshima-u.ac.jp
Sponsor or person
Institute
Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029782
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