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The Application and Evaluation of eHealth Literacy (eHL) Concept (eHL)

Primary Purpose

Type 2 Diabetes Mellitus, Chronic Kidney Diseases, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
experience learning programs of eHealth care
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring Chronic disease, eHealth literacy, patient engagement, experience learning theory, Self-management, empowerment, eHealth care

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Yang Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experience learning programs of eHealth care

Usual care

Arm Description

Patients in the experimental group received 6 sections of activities.

Patients in control group received usual care

Outcomes

Primary Outcome Measures

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 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 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 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.
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 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 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 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
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 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 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 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.
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 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 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 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.

Secondary Outcome Measures

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) .
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) .
The change in HbA1C level at the end of the intervention
The health outcome indicator of management of diabetes
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
The change in Triglycerides level at the end of the intervention
The health outcome indicator of management of lipid
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
The change in Cholesterol level at the end of the intervention
The health outcome indicator of management of lipid
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

Full Information

First Posted
November 15, 2021
Last Updated
December 17, 2021
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05180604
Brief Title
The Application and Evaluation of eHealth Literacy (eHL) Concept
Acronym
eHL
Official Title
Improving Patients With Chronic Disease to Engage in the eHealth Care Environment: the Application and Evaluation of eHealth Literacy Concept
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Chronic Kidney Diseases, Cardiovascular Diseases
Keywords
Chronic disease, eHealth literacy, patient engagement, experience learning theory, Self-management, empowerment, eHealth care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experience learning programs of eHealth care
Arm Type
Experimental
Arm Description
Patients in the experimental group received 6 sections of activities.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients in control group received usual care
Intervention Type
Behavioral
Intervention Name(s)
experience learning programs of eHealth care
Intervention Description
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
Primary Outcome Measure Information:
Title
Baseline of eHealth Literacy Questionnaire scores
Description
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.
Time Frame
The pretest is completed when the patients agrees to join the intervention.
Title
The eHealth Literacy Questionnaire scores at the end of intervention
Description
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.
Time Frame
The post-test 1 is completed at the end of the 6 weeks intervention
Title
The eHealth Literacy Questionnaire scores after intervention at 3 months
Description
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.
Time Frame
The post-test 2 is completed after intervention at 3 months
Title
The eHealth Literacy Questionnaire scores after intervention at 6 months
Description
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.
Time Frame
The post-test 3 is completed after intervention at 6 months
Title
Baseline of The acceptance of eHealth care scores
Description
The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device
Time Frame
The pretest is completed when the patients agrees to join the intervention.
Title
The acceptance of eHealth care scores at the end of intervention
Description
The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device
Time Frame
The post-test 1 is completed at the end of the 6 weeks intervention
Title
The acceptance of eHealth care scores after intervention at 3 months
Description
The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device
Time Frame
The post-test 2 is completed after intervention at 3 months
Title
The acceptance of eHealth care scores after intervention at 6 months
Description
The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device
Time Frame
The post-test 3 is completed after intervention at 6 months
Title
Baseline of Health Technology Usage Sore
Description
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.
Time Frame
The pretest is completed when the patients agrees to join the intervention.
Title
The Health Technology Usage Sore at the end of intervention
Description
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.
Time Frame
The post-test 1 is completed at the end of the 6 weeks intervention
Title
The Health Technology Usage Sore after intervention at 3 months
Description
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.
Time Frame
The post-test 2 is completed after intervention at 3 months
Title
The Health Technology Usage Sore after intervention at 6 months
Description
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.
Time Frame
The post-test 3 is completed after intervention at 6 months
Title
Baseline of Patient Health Engagement score
Description
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.
Time Frame
The pretest is completed when the patients agrees to join the intervention.
Title
The Patient Health Engagement score at the end of the intervention
Description
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.
Time Frame
The post-test 1 is completed at the end of the 6 weeks intervention
Title
The Patient Health Engagement score after intervention at 3 months
Description
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.
Time Frame
The post-test 2 is completed after intervention at 3 months
Title
The Patient Health Engagement score after intervention at 6 months
Description
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.
Time Frame
The post-test 3 is completed after intervention at 6 months
Secondary Outcome Measure Information:
Title
The change in renal function level at the end of the intervention
Description
The health outcome indicator of management of renal disease by using the estimated Glomerular filtration rate(eGRF) .
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
Title
The change Trajectory of renal function level from baseline to after intervention at 6 months and 1 year
Description
The health outcome indicator of management of renal disease by using the estimated Glomerular filtration rate(eGRF) .
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
Title
The change in HbA1C level at the end of the intervention
Description
The health outcome indicator of management of diabetes
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
Title
The change Trajectory of HbA1C level from baseline to after the intervention at 3, 6, and 12 months
Description
The health outcome indicator of management of diabetes
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
Title
The change in Triglycerides level at the end of the intervention
Description
The health outcome indicator of management of lipid
Time Frame
To collect two-time point data by chart review. Those were before the intervention and the end of the six weeks intervention
Title
The change Trajectory of Triglycerides level from baseline to after the intervention at 3 , 6 and 12 months
Description
The health outcome indicator of management of lipid
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.
Title
The change in Cholesterol level at the end of the intervention
Description
The health outcome indicator of management of lipid
Time Frame
To collect two-time point data by chart review. Those were before the intervention and the end of the 6 weeks intervention
Title
The change Trajectory of Cholesterol level from baseline to after the intervention at 3, 6 and 12 months
Description
The health outcome indicator of management of lipid
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chi Chen, Ph.D.
Organizational Affiliation
National Yang Ming University
Official's Role
Study Chair
Facility Information:
Facility Name
National Yang Ming University
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29434011
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 Res. 2018 Feb 12;20(2):e36. doi: 10.2196/jmir.8371.
Results Reference
result
PubMed Identifier
25870566
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.
Results Reference
result
PubMed Identifier
27025228
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: 10.2196/humanfactors.3696.
Results Reference
result
PubMed Identifier
28448497
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 cardiovascular risk: Rasch analyses. PLoS One. 2017 Apr 27;12(4):e0175372. doi: 10.1371/journal.pone.0175372. eCollection 2017.
Results Reference
result
PubMed Identifier
32593981
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.
Results Reference
result
PubMed Identifier
22193825
Citation
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.
Results Reference
result
PubMed Identifier
25295771
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.
Results Reference
result
PubMed Identifier
20202779
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.
Results Reference
result
Links:
URL
https://doi.org/10.2196/jmir.8371
Description
A Multidimensional Tool Based on the eHealth Literacy Framework: Development and Initial Validity Testing of the eHealth Literacy Questionnaire (eHLQ)
URL
https://doi.org/10.3389/fpsyg.2015.00274
Description
Measuring patient engagement: development and psychometric properties of the Patient Health Engagement (PHE) Scale.

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The Application and Evaluation of eHealth Literacy (eHL) Concept

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