Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes

NCT ID: NCT03440203

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 975 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-11
• Study Completion Date: 2017-10-22

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.

Conditions

Diabetic Neuropathy Peripheral; Activities of Daily Living

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

no Diabetic neuropathy

difficult activities of daily living in each group

Intervention Type: OTHER

Compare the severity of pain by the severity of diabetic peripheral neuropathy. Compare the difficulties in ADLs in three group of diabetic patients

Diabetic peripheral neuropathy

difficult activities of daily living in each group

Intervention Type: OTHER

Compare the severity of pain by the severity of diabetic peripheral neuropathy. Compare the difficulties in ADLs in three group of diabetic patients

Diabetic peripheral neuropathic pain

difficult activities of daily living in each group

Intervention Type: OTHER

Compare the severity of pain by the severity of diabetic peripheral neuropathy. Compare the difficulties in ADLs in three group of diabetic patients

Interventions

difficult activities of daily living in each group

Compare the severity of pain by the severity of diabetic peripheral neuropathy. Compare the difficulties in ADLs in three group of diabetic patients

Intervention Type: OTHER

Other Intervention Names

severity of pain in each group

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Okayama University

OTHER

Sponsor Role: lead

Responsible Party

Mi Mi Thet Mon Win

Graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi Mi Thet Mon Win, PhD student

Role: PRINCIPAL_INVESTIGATOR

Graduate School of Health Sciences, Okayama University

Locations

Okayama University

Okayama, , Japan

Countries

Japan

Other Identifiers

Ethics/DMR/2017/049

Identifier Type: OTHER

Identifier Source: secondary_id

D16-05

Identifier Type: -

Identifier Source: org_study_id