The Application and Evaluation of eHealth Literacy (eHL) Concept

Cardiovascular Diseases Clinical Trial

— eHL  

Official title:

Improving Patients With Chronic Disease to Engage in the eHealth Care Environment: the Application and Evaluation of eHealth Literacy Concept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180604
• Other study ID #: MOST-107-2314-B-010-014-MY3
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Diseases
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

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.

External Links

•   A Multidimensional Tool Based on the eHealth Literacy Framework: Development and Initial Validity Testing of the eHealth Literacy Questionnaire (eHLQ)
•   Measuring patient engagement: development and psychometric properties of the Patient Health Engagement (PHE) Scale.