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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 8, 2017

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: E-health education group
    • E-health education group will be received the shared care program using e-health education.
  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Glycated hemoglobin (HbA1c)
    • Time Frame: up to 6 months after the experiment
    • glucose index

Secondary Measures

  • Perceived diabetes self-management abilty using questionnaire
    • Time Frame: baseline, 3 and 6 months after the experiment
    • self-management abilty
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Li-Li Chen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Li-Li Chen, Principal Investigator – China Medical University Hospital
  • Overall Official(s)
    • Chen Li-Li, PhD, Study Director, China Medical University, Taichung, Taiwan
    • Pai Lee-Wen, PhD, Principal Investigator, Department of Nursing, Central Taiwan University of Science and Technology, Taichung, Taiwan
  • Overall Contact(s)
    • Chen Li-Li, PhD, +886-955741362, lily@mail.cmu.edu.tw

References

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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.

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.

Citations Reporting on Results

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Beard E, Clark M, Hurel S, Cooke D. Do people with diabetes understand their clinical marker of long-term glycemic control (HbA1c levels) and does this predict diabetes self-care behaviours and HbA1c? Patient Educ Couns. 2010 Aug;80(2):227-32. doi: 10.1016/j.pec.2009.11.008. Epub 2009 Dec 24.

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.

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.

Breen GM, Zhang NJ. Introducing ehealth to nursing homes: theoretical analysis of improving resident care. J Med Syst. 2008 Apr;32(2):187-92.

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.

Graffigna G, Barello S, Bonanomi A, Menichetti J. The Motivating Function of Healthcare Professional in eHealth and mHealth Interventions for Type 2 Diabetes Patients and the Mediating Role of Patient Engagement. J Diabetes Res. 2016;2016:2974521. doi: 10.1155/2016/2974521. Epub 2016 Jan 5. Erratum in: J Diabetes Res. 2019 Nov 20;2019:9246276.

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.

Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, Lernmark A, Metzger BE, Nathan DM; National Academy of Clinical Biochemistry. Position statement executive summary: guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Diabetes Care. 2011 Jun;34(6):1419-23. doi: 10.2337/dc11-9997.

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