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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
E-health Education
Routine care
Sponsored by
Li-Li Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes mellitus, application, e-health education

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Puli Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

E-health education group

Routine care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glycated hemoglobin (HbA1c)
glucose index

Secondary Outcome Measures

Perceived diabetes self-management abilty using questionnaire
self-management abilty
quality of life using questionnaire
the general well-being of individuals and societies, outlining negative and positive features of life

Full Information

First Posted
February 19, 2017
Last Updated
February 21, 2017
Sponsor
Li-Li Chen
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1. Study Identification

Unique Protocol Identification Number
NCT03061266
Brief Title
The Application of the E-health Education on Shared Care Program for Patients With Type 2 Diabetes
Official Title
The Application of the E-health Education on Shared Care Program for Patients With Type 2 Diabetes - Taking Local Teaching Hospital for Example
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2016 (Actual)
Primary Completion Date
March 8, 2017 (Anticipated)
Study Completion Date
March 8, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li-Li Chen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
type 2 diabetes mellitus, application, e-health education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-health education group
Arm Type
Experimental
Arm Description
E-health education group will be received the shared care program using e-health education.
Arm Title
Routine care
Arm Type
Other
Arm Description
Control group will be received the shared care program as advised by clinical professionals, which included medications, dietary control and general physical activities.
Intervention Type
Behavioral
Intervention Name(s)
E-health Education
Intervention Description
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
Other
Intervention Name(s)
Routine care
Intervention Description
Routine care on shared care program as advised by clinical professionals, which included medications, dietary control and general physical activities.
Primary Outcome Measure Information:
Title
Glycated hemoglobin (HbA1c)
Description
glucose index
Time Frame
up to 6 months after the experiment
Secondary Outcome Measure Information:
Title
Perceived diabetes self-management abilty using questionnaire
Description
self-management abilty
Time Frame
baseline, 3 and 6 months after the experiment
Title
quality of life using questionnaire
Description
the general well-being of individuals and societies, outlining negative and positive features of life
Time Frame
baseline, 3 and 6 months after the experiment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Li-Li, PhD
Phone
+886-955741362
Email
lily@mail.cmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Pai Lee-Wen, PhD
Phone
+886-955741362
Email
lwpai@ctust.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Li-Li, PhD
Organizational Affiliation
China Medical University, Taichung, Taiwan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pai Lee-Wen, PhD
Organizational Affiliation
Department of Nursing, Central Taiwan University of Science and Technology, Taichung, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puli Christian Hospital
City
Nantou
ZIP/Postal Code
54510
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Mei-Chih
Phone
+886--49291-2151
Email
pch@mail.pch.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Frederick V, Matilda SA, Margaret AK, Seth A. Population-based study of diabetic mellitus prevalence and its associated factors in adult Ghanaians in the greater Accra region. International Journal of Diabetes in Developing Countries. 2011; 31:149-53.
Results Reference
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PubMed Identifier
23570503
Citation
Lin CC, Li CI, Hsiao CY, Liu CS, Yang SY, Lee CC, Li TC. Time trend analysis of the prevalence and incidence of diagnosed type 2 diabetes among adults in Taiwan from 2000 to 2007: a population-based study. BMC Public Health. 2013 Apr 9;13:318. doi: 10.1186/1471-2458-13-318.
Results Reference
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Citation
Shen FC, Chen CY, Su SC, Liu RT. The Prevalence and Risk Factors of Diabetic Nephropathy in Taiwanese Type 2 Diabetes-A Hospital-Based Study. Acta Nephrologica. 2009; 23:90-95.
Results Reference
background
Citation
World Health Organization. National Diabetes Fact Sheet 2015. 2015. Available at http://www.who.int/mediacentre/factsheets/fs312/en/index.html. Last accessed 4 May 2015.
Results Reference
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PubMed Identifier
23264422
Citation
American Diabetes Association. Standards of medical care in diabetes--2013. Diabetes Care. 2013 Jan;36 Suppl 1(Suppl 1):S11-66. doi: 10.2337/dc13-S011. No abstract available.
Results Reference
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PubMed Identifier
20036098
Citation
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Results Reference
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PubMed Identifier
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Citation
Cheung NW, Yue DK, Kotowicz MA, Jones PA, Flack JR. A comparison of diabetes clinics with different emphasis on routine care, complications assessment and shared care. Diabet Med. 2008 Aug;25(8):974-8. doi: 10.1111/j.1464-5491.2008.02522.x.
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PubMed Identifier
18461822
Citation
Breen GM, Zhang NJ. Introducing ehealth to nursing homes: theoretical analysis of improving resident care. J Med Syst. 2008 Apr;32(2):187-92. doi: 10.1007/s10916-007-9121-9.
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PubMed Identifier
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Citation
Chiou ST, Lin HD, Yu NC, Hseuh HK, Lin LH, Lin LT, Chen TJ, Lai MS. An initial assessment of the feasibility and effectiveness of implementing diabetes shared care system in Taiwan--some experiences from I-Lan County. Diabetes Res Clin Pract. 2001 Nov;54 Suppl 1:S67-73. doi: 10.1016/s0168-8227(01)00311-4.
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Citation
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Citation
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Citation
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The Application of the E-health Education on Shared Care Program for Patients With Type 2 Diabetes

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