- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05180604
The Application and Evaluation of eHealth Literacy (eHL) Concept (eHL)
Improving Patients With Chronic Disease to Engage in the eHealth Care Environment: the Application and Evaluation of eHealth Literacy Concept
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei City, Taiwan
- National Yang Ming University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: experience learning programs of eHealth care
Patients in the experimental group received 6 sections of activities.
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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
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No Intervention: Usual care
Patients in control group received usual care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Baseline of eHealth Literacy Questionnaire scores
Time Frame: The pretest is completed when the patients agrees to join the intervention.
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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.
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The pretest is completed when the patients agrees to join the intervention.
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The eHealth Literacy Questionnaire scores at the end of intervention
Time Frame: The post-test 1 is completed at the end of the 6 weeks intervention
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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.
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The post-test 1 is completed at the end of the 6 weeks intervention
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The eHealth Literacy Questionnaire scores after intervention at 3 months
Time Frame: The post-test 2 is completed 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.
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The post-test 2 is completed after intervention at 3 months
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The eHealth Literacy Questionnaire scores after intervention at 6 months
Time Frame: The post-test 3 is completed 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.
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The post-test 3 is completed after intervention at 6 months
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Baseline of The acceptance of eHealth care scores
Time Frame: The pretest is completed when the patients agrees to join the intervention.
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The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device
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The pretest is completed when the patients agrees to join the intervention.
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The acceptance of eHealth care scores at the end of intervention
Time Frame: The post-test 1 is completed at the end of the 6 weeks intervention
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The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device
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The post-test 1 is completed at the end of the 6 weeks intervention
|
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The acceptance of eHealth care scores after intervention at 3 months
Time Frame: The post-test 2 is completed after intervention at 3 months
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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
|
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The acceptance of eHealth care scores after intervention at 6 months
Time Frame: The post-test 3 is completed after intervention at 6 months
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The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device
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The post-test 3 is completed after intervention at 6 months
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Baseline of Health Technology Usage Sore
Time Frame: The pretest is completed when the patients agrees to join the intervention.
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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.
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The pretest is completed when the patients agrees to join the intervention.
|
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The Health Technology Usage Sore at the end of intervention
Time Frame: The post-test 1 is completed at the end of the 6 weeks 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.
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The post-test 1 is completed at the end of the 6 weeks intervention
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The Health Technology Usage Sore after intervention at 3 months
Time Frame: The post-test 2 is completed 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
|
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The Health Technology Usage Sore after intervention at 6 months
Time Frame: The post-test 3 is completed 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.
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The post-test 3 is completed after intervention at 6 months
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Baseline of Patient Health Engagement score
Time Frame: The pretest is completed when the patients agrees to join the intervention.
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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.
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The pretest is completed when the patients agrees to join the intervention.
|
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The Patient Health Engagement score at the end of the intervention
Time Frame: The post-test 1 is completed at the end of the 6 weeks intervention
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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
|
|
The Patient Health Engagement score after intervention at 3 months
Time Frame: The post-test 2 is completed after intervention at 3 months
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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.
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The post-test 2 is completed after intervention at 3 months
|
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The Patient Health Engagement score after intervention at 6 months
Time Frame: The post-test 3 is completed after intervention at 6 months
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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.
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The post-test 3 is completed after intervention at 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The change in renal function level at the end of the intervention
Time Frame: To collect two-time point data by chart review. Those were before the intervention and the end of the the 6 weeks intervention
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The health outcome indicator of management of renal disease by using the estimated Glomerular filtration rate(eGRF) .
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To collect two-time point data by chart review. Those were before the intervention and the end of the the 6 weeks intervention
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The change Trajectory of renal function level from baseline to after intervention at 6 months and 1 year
Time Frame: 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
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The health outcome indicator of management of renal disease by using the estimated Glomerular filtration rate(eGRF) .
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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
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The change in HbA1C level at the end of the intervention
Time Frame: To collect two-time point data by chart review. Those were before the intervention and the end of the the 6 weeks intervention
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The health outcome indicator of management of diabetes
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To collect two-time point data by chart review. Those were before the intervention and the end of the the 6 weeks intervention
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The change Trajectory of HbA1C level from baseline to after the intervention at 3, 6, and 12 months
Time Frame: 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
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The health outcome indicator of management of diabetes
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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
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The change in Triglycerides level at the end of the intervention
Time Frame: To collect two-time point data by chart review. Those were before the intervention and the end of the six weeks intervention
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The health outcome indicator of management of lipid
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To collect two-time point data by chart review. Those were before the intervention and the end of the six weeks intervention
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The change Trajectory of Triglycerides level from baseline to after the intervention at 3 , 6 and 12 months
Time Frame: 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.
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The health outcome indicator of management of lipid
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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.
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The change in Cholesterol level at the end of the intervention
Time Frame: To collect two-time point data by chart review. Those were before the intervention and the end of the 6 weeks intervention
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The health outcome indicator of management of lipid
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To collect two-time point data by chart review. Those were before the intervention and the end of the 6 weeks intervention
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The change Trajectory of Cholesterol level from baseline to after the intervention at 3, 6 and 12 months
Time Frame: 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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The health outcome indicator of management of lipid
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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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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yu-Chi Chen, Ph.D., National Yang Ming University
Publications and helpful links
General Publications
- 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 Res. 2018 Feb 12;20(2):e36. doi: 10.2196/jmir.8371.
- 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.
- 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: 10.2196/humanfactors.3696.
- 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 cardiovascular risk: Rasch analyses. PLoS One. 2017 Apr 27;12(4):e0175372. doi: 10.1371/journal.pone.0175372. eCollection 2017.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOST-107-2314-B-010-014-MY3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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