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Clinical Trials/NCT03061266
NCT03061266
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The Application of the E-health Education on Shared Care Program for Patients With Type 2 Diabetes - Taking Local Teaching Hospital for Example

Li-Li Chen1 site in 1 country110 target enrollmentMarch 9, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Li-Li Chen
Enrollment
110
Locations
1
Primary Endpoint
Glycated hemoglobin (HbA1c)
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2016
End Date
March 8, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Li-Li Chen
Responsible Party
Sponsor Investigator
Principal Investigator

Li-Li Chen

Principal Investigator

China Medical University Hospital

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.

Outcomes

Primary Outcomes

Glycated hemoglobin (HbA1c)

Time Frame: up to 6 months after the experiment

glucose index

Secondary Outcomes

  • quality of life using questionnaire(baseline, 3 and 6 months after the experiment)
  • Perceived diabetes self-management abilty using questionnaire(baseline, 3 and 6 months after the experiment)

Study Sites (1)

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