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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05180604
Other study ID # MOST-107-2314-B-010-014-MY3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date November 15, 2021

Study information

Verified date December 2021
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to explore the effectiveness of experience learning program of eHealth care to improve the chronic patients' eHL in engaging with the eHealth care system on the indicators on eHealth literacy, patient health engagement, e-Health usage status among Chronic disease patients included type 2 diabetes patients, Chronic kidney disease, and Cardiovascular Diseases.


Description:

Chronic diseases are irreversible that incurs considerable medical and economic costs. Even if the government and medical health care system make an effort to improve care and recommend e-health care, the incidence and prevalence rates of chronic diseases have not decreased but increased, and participants have even become the main cause of kidney disease. Technology and daily life has become more inseparable, which also led to the change of the traditional face to face health care model. The chronic disease care is gradually transitioning into the smart eHealth care era, patients are in need of learning how to face innovative ways of using care and resources. eHealth literacy (eHL)is the essential element that determines if patient can adapt to the rapidly changing health care system. Due to the disciplinary integration of medical and technology, eHealth care provides continuous care for patients. But, it is still necessary to return to patient-centered care thinking and improving patients' knowledge and ability to use eHealth care technology. This can be applied to disease care, and implemented for daily self-health management. Therefore, this study explores the effects of intervention and the learning process and experience of patients through an experience learning program of eHealth care.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date November 15, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Diagnosed as a type 2 diabetes patients, Chronic kidney disease, and Cardiovascular Diseases more than three months. - At least 20 years old, with clear consciousness and able to communicate in Mandarin or Taiwanese. - Possess a mobile phone or tablet with internet capabilities. - Consent to participate in this research and be willing to sign a consent form. Exclusion Criteria: - Suffering from serious diseases, such as: general paralysis, mental disorders, cognitive function abnormalities, etc. - Those who cannot communicate in Mandarin or Taiwanese. - Those who refuse to participate in this research.

Study Design


Intervention

Behavioral:
experience learning programs of eHealth care
The experience learning programs of eHealth care was included six sections of activities. Six activities were conducted based on eHealth literacy framework and experience learning theory to improve patients' abilities to engage in eHealth care service. The outcome indicators were eHealth literacy, patient health engagement, the acceptance of eHealth care, eHealth usage status, and their learning experience

Locations

Country Name City State
Taiwan National Yang Ming University Taipei City

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

Alpay L, van der Boog P, Dumaij A. An empowerment-based approach to developing innovative e-health tools for self-management. Health Informatics J. 2011 Dec;17(4):247-55. doi: 10.1177/1460458211420089. — View Citation

Graffigna G, Barello S, Bonanomi A, Lozza E. Measuring patient engagement: development and psychometric properties of the Patient Health Engagement (PHE) Scale. Front Psychol. 2015 Mar 27;6:274. doi: 10.3389/fpsyg.2015.00274. eCollection 2015. — View Citation

Kayser L, Karnoe A, Furstrand D, Batterham R, Christensen KB, Elsworth G, Osborne RH. A Multidimensional Tool Based on the eHealth Literacy Framework: Development and Initial Validity Testing of the eHealth Literacy Questionnaire (eHLQ). J Med Internet Re — View Citation

Kayser L, Kushniruk A, Osborne RH, Norgaard O, Turner P. Enhancing the Effectiveness of Consumer-Focused Health Information Technology Systems Through eHealth Literacy: A Framework for Understanding Users' Needs. JMIR Hum Factors. 2015 May 20;2(1):e9. doi — View Citation

Knight E, Stuckey MI, Petrella RJ. Health promotion through primary care: enhancing self-management with activity prescription and mHealth. Phys Sportsmed. 2014 Sep;42(3):90-9. doi: 10.3810/psm.2014.09.2080. — View Citation

Kreps GL, Neuhauser L. New directions in eHealth communication: opportunities and challenges. Patient Educ Couns. 2010 Mar;78(3):329-36. doi: 10.1016/j.pec.2010.01.013. Epub 2010 Mar 3. Review. — View Citation

Richtering SS, Morris R, Soh SE, Barker A, Bampi F, Neubeck L, Coorey G, Mulley J, Chalmers J, Usherwood T, Peiris D, Chow CK, Redfern J. Examination of an eHealth literacy scale and a health literacy scale in a population with moderate to high cardiovasc — View Citation

Schillinger D. The Intersections Between Social Determinants of Health, Health Literacy, and Health Disparities. Stud Health Technol Inform. 2020 Jun 25;269:22-41. doi: 10.3233/SHTI200020. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline of eHealth Literacy Questionnaire scores Evaluate the patient's eHL level, including 7 dimensions (1) Using technology to process health information, (2) Understanding of health concepts and languages, (3)Ability to actively engage with digital service, (4)Feel safe and in control, (5) Motivated to engage with digital service, (6) Access to digital services that work (7)Digital services that suit individual. The higher the score, the better the eHL. The pretest is completed when the patients agrees to join the intervention.
Primary The eHealth Literacy Questionnaire scores at the end of intervention Evaluate the patient's eHL level, including 7 dimensions (1) Using technology to process health information, (2) Understanding of health concepts and languages, (3)Ability to actively engage with digital service, (4)Feel safe and in control, (5) Motivated to engage with digital service, (6) Access to digital services that work (7)Digital services that suit individual. The higher the score, the better the eHL. The post-test 1 is completed at the end of the 6 weeks intervention
Primary The eHealth Literacy Questionnaire scores after intervention at 3 months Evaluate the patient's eHL level, including 7 dimensions (1) Using technology to process health information, (2) Understanding of health concepts and languages, (3)Ability to actively engage with digital service, (4)Feel safe and in control, (5) Motivated to engage with digital service, (6) Access to digital services that work (7)Digital services that suit individual. The higher the score, the better the eHL. The post-test 2 is completed after intervention at 3 months
Primary The eHealth Literacy Questionnaire scores after intervention at 6 months Evaluate the patient's eHL level, including 7 dimensions (1) Using technology to process health information, (2) Understanding of health concepts and languages, (3)Ability to actively engage with digital service, (4)Feel safe and in control, (5) Motivated to engage with digital service, (6) Access to digital services that work (7)Digital services that suit individual. The higher the score, the better the eHL. The post-test 3 is completed after intervention at 6 months
Primary Baseline of The acceptance of eHealth care scores The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device The pretest is completed when the patients agrees to join the intervention.
Primary The acceptance of eHealth care scores at the end of intervention The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device The post-test 1 is completed at the end of the 6 weeks intervention
Primary The acceptance of eHealth care scores after intervention at 3 months The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device The post-test 2 is completed after intervention at 3 months
Primary The acceptance of eHealth care scores after intervention at 6 months The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device The post-test 3 is completed after intervention at 6 months
Primary Baseline of Health Technology Usage Sore Use self-developed structured questionnaires to investigate the types of health technology use and monitoring items. Use types include computer or network systems, mobile apps, health monitoring systems or wearable devices (such as pedometers, smart bracelets, heart rate monitors, blood pressure monitors, Blood glucose meter, blood pressure meter, blood glucose meter or weight scale, etc.) or other, monitoring items include blood pressure, blood sugar, weight, diet, sleep, heart rate, steps or other health data. The higher the number, the more items are monitored, the total score The higher the level, the better the use of health technology. The pretest is completed when the patients agrees to join the intervention.
Primary The Health Technology Usage Sore at the end of intervention Use self-developed structured questionnaires to investigate the types of health technology use and monitoring items. Use types include computer or network systems, mobile apps, health monitoring systems or wearable devices (such as pedometers, smart bracelets, heart rate monitors, blood pressure monitors, Blood glucose meter, blood pressure meter, blood glucose meter or weight scale, etc.) or other, monitoring items include blood pressure, blood sugar, weight, diet, sleep, heart rate, steps or other health data. The higher the number, the more items are monitored, the total score The higher the level, the better the use of health technology. The post-test 1 is completed at the end of the 6 weeks intervention
Primary The Health Technology Usage Sore after intervention at 3 months Use self-developed structured questionnaires to investigate the types of health technology use and monitoring items. Use types include computer or network systems, mobile apps, health monitoring systems or wearable devices (such as pedometers, smart bracelets, heart rate monitors, blood pressure monitors, Blood glucose meter, blood pressure meter, blood glucose meter or weight scale, etc.) or other, monitoring items include blood pressure, blood sugar, weight, diet, sleep, heart rate, steps or other health data. The higher the number, the more items are monitored, the total score The higher the level, the better the use of health technology. The post-test 2 is completed after intervention at 3 months
Primary The Health Technology Usage Sore after intervention at 6 months Use self-developed structured questionnaires to investigate the types of health technology use and monitoring items. Use types include computer or network systems, mobile apps, health monitoring systems or wearable devices (such as pedometers, smart bracelets, heart rate monitors, blood pressure monitors, Blood glucose meter, blood pressure meter, blood glucose meter or weight scale, etc.) or other, monitoring items include blood pressure, blood sugar, weight, diet, sleep, heart rate, steps or other health data. The higher the number, the more items are monitored, the total score The higher the level, the better the use of health technology. The post-test 3 is completed after intervention at 6 months
Primary Baseline of Patient Health Engagement score The scale is thought of as a self-administering tool by the patient in order to diagnose his/ her This scale has a total of 5 questions. The higher the number, the higher the patient engagement it is. The pretest is completed when the patients agrees to join the intervention.
Primary The Patient Health Engagement score at the end of the intervention The scale is thought of as a self-administering tool by the patient in order to diagnose his/ her This scale has a total of 5 questions. The higher the number, the higher the patient engagement it is. The post-test 1 is completed at the end of the 6 weeks intervention
Primary The Patient Health Engagement score after intervention at 3 months The scale is thought of as a self-administering tool by the patient in order to diagnose his/ her This scale has a total of 5 questions. The higher the number, the higher the patient engagement it is. The post-test 2 is completed after intervention at 3 months
Primary The Patient Health Engagement score after intervention at 6 months The scale is thought of as a self-administering tool by the patient in order to diagnose his/ her This scale has a total of 5 questions. The higher the number, the higher the patient engagement it is. The post-test 3 is completed after intervention at 6 months
Secondary The change in renal function level at the end of the intervention The health outcome indicator of management of renal disease by using the estimated Glomerular filtration rate(eGRF) . To collect two-time point data by chart review. Those were before the intervention and the end of the the 6 weeks intervention
Secondary The change Trajectory of renal function level from baseline to after intervention at 6 months and 1 year The health outcome indicator of management of renal disease by using the estimated Glomerular filtration rate(eGRF) . To collect three-time point data by chart review. Those were before the intervention, the end of the 6 weeks intervention, and after intervention at six months and 1 year
Secondary The change in HbA1C level at the end of the intervention The health outcome indicator of management of diabetes To collect two-time point data by chart review. Those were before the intervention and the end of the the 6 weeks intervention
Secondary The change Trajectory of HbA1C level from baseline to after the intervention at 3, 6, and 12 months The health outcome indicator of management of diabetes To collect four-time point data by chart review. Those were before the intervention, the end of the 6 weeks intervention, after the intervention at three months, after the intervention at six months, and after the intervention at twelve months
Secondary The change in Triglycerides level at the end of the intervention The health outcome indicator of management of lipid To collect two-time point data by chart review. Those were before the intervention and the end of the six weeks intervention
Secondary The change Trajectory of Triglycerides level from baseline to after the intervention at 3 , 6 and 12 months The health outcome indicator of management of lipid To collect four-time point data by chart review. Those were before the intervention, the end of the 6 weeks intervention, after the intervention at three months, after the intervention at six months, and after the intervention at twelve months.
Secondary The change in Cholesterol level at the end of the intervention The health outcome indicator of management of lipid To collect two-time point data by chart review. Those were before the intervention and the end of the 6 weeks intervention
Secondary The change Trajectory of Cholesterol level from baseline to after the intervention at 3, 6 and 12 months The health outcome indicator of management of lipid To collect two-time point data by chart review. Those were before the intervention, the end of the 6 weeks intervention, after the intervention at three months, after the intervention at six months, and after the intervention at twelve months.
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