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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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ClinicalTrials.gov Identifier: NCT03061266
Recruitment Status : Unknown
Verified February 2017 by Li-Li Chen, China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Li-Li Chen, China Medical University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: E-health Education Other: Routine care Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
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
Actual Study Start Date : March 9, 2016
Estimated Primary Completion Date : March 8, 2017
Estimated Study Completion Date : March 8, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: E-health education group
E-health education group will be received the shared care program using e-health education.
 Behavioral: 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.
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.
 Other: Routine care
Routine care on shared care program as advised by clinical professionals, which included medications, dietary control and general physical activities.


Outcome Measures
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Primary Outcome Measures :
  1. Glycated hemoglobin (HbA1c) [ Time Frame: up to 6 months after the experiment ]
    glucose index


Secondary Outcome Measures :
  1. Perceived diabetes self-management abilty using questionnaire [ Time Frame: baseline, 3 and 6 months after the experiment ]
    self-management abilty

  2. quality of life using questionnaire [ Time Frame: baseline, 3 and 6 months after the experiment ]
    the general well-being of individuals and societies, outlining negative and positive features of life


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061266


Contacts
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Contact: Chen Li-Li, PhD +886-955741362 lily@mail.cmu.edu.tw
Contact: Pai Lee-Wen, PhD +886-955741362 lwpai@ctust.edu.tw

Locations
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Taiwan
Puli Christian Hospital Recruiting
Nantou, Taiwan, 54510
Contact: Chen Mei-Chih    +886--49291-2151    pch@mail.pch.org.tw   
Sponsors and Collaborators
Li-Li Chen
Investigators
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Study Director: Chen Li-Li, PhD China Medical University, Taichung, Taiwan
Principal Investigator: Pai Lee-Wen, PhD Department of Nursing, Central Taiwan University of Science and Technology, Taichung, Taiwan
More Information
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Publications of Results:
Bhatti S A, Khan A H, Yaqoob N. Glycated hemoglobin(HbA1c);screening for undiagnosed diasetes in healthy individuals in Sargodha. The Professional Medical Journal.2015; 22(2):208-214.
Pacaud D., Kelley H, Downey A , Chiasson M. Successful Delivery of Diabetes Self-Care Education and Follow-Up through eHealth Media. Canadian Journal of Diabetes 2012; 36(5): 257-262.

Other Publications:
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.
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.
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.

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Responsible Party: Li-Li Chen, Principal Investigator, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03061266     History of Changes
Other Study ID Numbers: CMUH105-REC2-013
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li-Li Chen, China Medical University Hospital:
type 2 diabetes mellitus, application, e-health education
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases