Clinical trial NCT03440203: Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes
Official title: Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Neuropathy Peripheral
Activities of Daily Living
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 975
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The patients went to the diabetic clinic at the outpatient department of Yangon General Hospital (YGH), North-Okkalapa General Hospital (NOGH), East Yangon General Hospital (EYGH), and West Yangon General Hospital (WYGH) in Myanmar used as the sample. These four hospitals are providing outpatient services for diabetics on selected weekdays. Most of the patients who are receiving the care are from Yangon Region.

Brief summary: The trend of diabetes prevalence was increased by comparing these two national surveys in 2009 and 2014. However, the studies only focused on the prevalence and risk of diabetes and non-communicable diseases in Myanmar. The study focused on the common complications of Diabetic Peripheral Neuropathy (DPN) is rare. The studies in other countries showed high prevalence rate and under-diagnosis of DPN. Most of the patients with DPN did not complain about their symptoms because of without prominent symptoms. DPN is the major complication of diabetes. According to the international studies, DPN has the hidden epidemic and is the common causes which can lead to disability and decreased the quality of life in diabetes. Therefore, the study focused on the prevalence of DPN and its impact on the ADLs is obligatory as the descriptive study to explore the actual situation.

Nursing care is not only for the patients in the hospital but also for the people in the community. Moreover, the nurses have to focus on all levels of prevention. Diabetes is the lifelong diseases and accessibility of health care for everyone with diabetes is a very important issue in the era with increased prevalence of diabetes. Therefore, we all have to focus not only on the primary prevention but also on the secondary and tertiary prevention of diabetes. The secondary and tertiary prevention in the diabetic patients also means the primary prevention of other diseases and disabilities (the complications of diabetes). For diabetic neuropathic patients, maintaining normal daily living is very important liked everyone.

The objective of this study is to evaluate the prevalence of DPN and DPNP in type 2 diabetic patients and impact on the activities of daily living. The descriptive, cross-sectional study design will be used in this study. The inclusion criteria are the person aged over 25 years of age who had already diagnosed type 2 diabetes mellitus, taking any anti-glycemic treatment. The persons who are suffering from neuropathy and neuropathic pain other than diabetes, severe illness of diabetic patients, mental illness and alcoholism will be excluded from this study. The patients who meet the inclusion criteria and come to outpatient diabetic clinics at YGH, NOGH, EYGH, and WYGH will be chosen as a sample after obtaining informed consent.

Data collection will be done at this outpatients diabetic clinic of these four hospitals. This study has already obtained ethical clearance from Nursing Science Ethical Review Committee, Graduate School of Health Sciences, Okayama University, Japan with the review number D1605. It will be carrying out after obtaining approval from Department of Medical Research, Myanmar. At the outset, informed consent will be obtained with detailed information about the purpose of research, the part they need to participate, possible benefits and their rights to withdraw.


Eligibility criteria: Inclusion Criteria:

* people aged over 25 years of age who have already been diagnosed with type 2 diabetes mellitus, and who are taking anti-glycemic treatment

Exclusion Criteria:

* people who are suffering from neuropathy and neuropathic pain other than diabetes, severe illness of diabetic patients, mental illness and alcoholism

Primary outcomes:
measure: Activities of daily living
timeFrame: on the days of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Okayama University
Study officials:
affiliation: Graduate School of Health Sciences, Okayama University
name: Mi Mi Thet Mon Win, PhD student
role: PRINCIPAL_INVESTIGATOR
References: