The Application of the E-health Education on Shared Care Program for Patients With Type 2 Diabetes

NCT ID: NCT03061266

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-09
• Study Completion Date: 2017-03-08

Brief Summary

This study will be a randomized controlled trial aimed at examining the effectiveness of the in e-health education on shared care program for patients with type 2 diabetes mellitus (T2DM). The experiment will be conducted over 1 year at a regional hospital in Taiwan. The research subjects will be excluded 160 patients with T2DM. Subjects assigned to an experimental group will receive the integrated care program, whereas those assigned to a control group will receive routine care. The membership of e-health education on shared care program is established by different type's professionals including diabetes physicians, pharmacists, dietitians and diabetes health teacher. Glycated hemoglobin (HbA1c) of subjects in both groups will be measured at three time points including 1 month before the experiment, and 2 and 5 months after the experiment. The self-management conditions and quality of life of the subjects will be also recorded using relevant scales.

Detailed Description

This study will be a randomized controlled trial aimed at examining the effectiveness of the in e-health education on shared care program for patients with type 2 diabetes mellitus (T2DM). The experiment will be conducted over 1 year at a regional hospital in Taiwan. The research subjects will be excluded 160 patients with T2DM. Subjects assigned to an experimental group will receive the integrated care program, whereas those assigned to a control group will receive routine care. The membership of e-health education on shared care program is established by different type's professionals including diabetes physicians, pharmacists, dietitians and diabetes health teacher. Glycated hemoglobin (HbA1c) of subjects in both groups will be measured at three time points including 1 month before the experiment, and 2 and 5 months after the experiment. The self-management conditions and quality of life of the subjects will be also recorded using relevant scales. SPSS+ 22.0 statistics software will be used for a statistical analysis, which will be presented in percentages, means, and standard deviations. Additionally, the chi-square test will be also to examine the homogeneity of both groups. Generalized estimating equations will be used to analyze repeated measurements in order to compare the efficacy of improving HbA1c, self-management, and quality of life. We anticipate that the results of this study will provide the e-health education on shared care program to clinical nursing staff to assist patients with T2DM in controlling their blood sugar as well as to improve their self-management and quality of life.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

E-health education group

E-health education group will be received the shared care program using e-health education.

Group Type: EXPERIMENTAL

E-health Education

Intervention Type: BEHAVIORAL

E-health education on shared care program will be established by different type's professionals including diabetes physicians, pharmacists, dietitians and diabetes health teacher.

Routine care

Control group will be received the shared care program as advised by clinical professionals, which included medications, dietary control and general physical activities.

Group Type: OTHER

Routine care

Intervention Type: OTHER

Routine care on shared care program as advised by clinical professionals, which included medications, dietary control and general physical activities.

Interventions

E-health Education

E-health education on shared care program will be established by different type's professionals including diabetes physicians, pharmacists, dietitians and diabetes health teacher.

Intervention Type: BEHAVIORAL

Routine care

Routine care on shared care program as advised by clinical professionals, which included medications, dietary control and general physical activities.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• participation with type 2 diabetes mellitus received oral medication.

Exclusion Criteria

• Studies were excluded from this study if participation had recently undergone serious operations, had a myocardial infarction, stroke, severe liver or kidney diseases, received injection medication,or any illness limiting participation in a physical activity program.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li-Li Chen

OTHER

Sponsor Role: lead

Responsible Party

Li-Li Chen

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chen Li-Li, PhD

Role: STUDY_DIRECTOR

China Medical University, Taichung, Taiwan

Pai Lee-Wen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing, Central Taiwan University of Science and Technology, Taichung, Taiwan

Locations

Puli Christian Hospital

Nantou City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chen Li-Li, PhD

Role: CONTACT

lily@mail.cmu.edu.tw

+886-955741362

Pai Lee-Wen, PhD

Role: CONTACT

lwpai@ctust.edu.tw

+886-955741362

Facility Contacts

Chen Mei-Chih

Role: primary

pch@mail.pch.org.tw

+886--49291-2151

References

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

CMUH105-REC2-013

Identifier Type: -

Identifier Source: org_study_id