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

NCT03061266 | Unknown DMC

• 1 other identifier: CMUH105-REC2-013
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus, application, e-health education

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1c)

  glucose index

  up to 6 months after the experiment

Secondary Outcomes (2)

• Perceived diabetes self-management abilty using questionnaire

  baseline, 3 and 6 months after the experiment

• quality of life using questionnaire

  baseline, 3 and 6 months after the experiment

Study Arms (2)

E-health education group

EXPERIMENTAL

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

Behavioral: E-health Education

Routine care

OTHER

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

Interventions

E-health Education BEHAVIORAL

E-health education on shared care program will be established by different type's professionals including diabetes physicians, pharmacists, dietitians and diabetes health teacher.

E-health education group

Routine care OTHER

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

Routine care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participation with type 2 diabetes mellitus received oral medication.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li-Li Chen: lead

Study Sites (1)

Puli Christian Hospital

Nantou City, 54510, Taiwan

RECRUITING

Related Publications (13)

• 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.

  BACKGROUND

• 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.

  PMID: 23570503 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23264422 RESULT

• 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.

  PMID: 20036098 RESULT

• 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.

  RESULT

• 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.

  PMID: 18959612 RESULT

• 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.

  PMID: 18461822 RESULT

• 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.

  PMID: 11580971 RESULT

• 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.

  PMID: 26881243 RESULT

• 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.

  RESULT

• 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.

  PMID: 21617111 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chen Li-Li, PhD

  China Medical University, Taichung, Taiwan

  STUDY DIRECTOR

• Pai Lee-Wen, PhD

  Department of Nursing, Central Taiwan University of Science and Technology, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Li-Li, PhD

CONTACT

+886-955741362; lily@mail.cmu.edu.tw

Pai Lee-Wen, PhD

CONTACT

+886-955741362; lwpai@ctust.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 23, 2017
• Study Start: March 9, 2016
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)