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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061266
• Other study ID #: CMUH105-REC2-013
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2017
• Last updated: February 21, 2017
• Start date: March 9, 2016
• Est. completion date: March 8, 2017

Study information

• Verified date: February 2017
• Source: China Medical University Hospital
• Contact: Chen Li-Li, PhD
• Phone: +886-955741362
• Email: lily[@]mail.cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 8, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Puli Christian Hospital	Nantou

Sponsors (1)

Lead Sponsor	Collaborator
Li-Li Chen

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

American Diabetes Association.. Standards of medical care in diabetes--2013. Diabetes Care. 2013 Jan;36 Suppl 1:S11-66. doi: 10.2337/dc13-S011. — View Citation

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: 10.101 — View Citation

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.

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

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 — View 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. — View Citation

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 a — View 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.

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.

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (HbA1c)	glucose index	up to 6 months after the experiment
Secondary	Perceived diabetes self-management abilty using questionnaire	self-management abilty	baseline, 3 and 6 months after the experiment
Secondary	quality of life using questionnaire	the general well-being of individuals and societies, outlining negative and positive features of life	baseline, 3 and 6 months after the experiment