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Effectiveness and feasibility of a disease management program strengthening good sleep and activities in people with diabetic nephropathy: A pilot study

Effectiveness and feasibility of a disease management program strengthening good sleep and activities in people with diabetic nephropathy: A pilot study - The study of effects on a diabetic nephropathy disease management program strengthening sleep and activities

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025906
Enrollment
50
Registered
2017-01-31
Start date
2017-03-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetic nephropathy

Interventions

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 cal
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

Sponsors

Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University
Lead Sponsor
Hiroshima Prefecture, Hiroshima City
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMICHIKO MORIYAMA

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

morimich@hiroshima-u.ac.jp082-257-5365

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026