Type 2 Diabetes MellituseHLNCT05180604
The Application and Evaluation of eHealth Literacy (eHL) Concept
A study testing experience learning programs of eHealth care in people with Type 2 Diabetes Mellitus and Chronic Kidney Diseases, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Chronic Kidney Diseases, Cardiovascular Diseases
- What is being tested?
- experience learning programs of eHealth care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Patients With Chronic Disease to Engage in the eHealth Care Environment: the Application and Evaluation of eHealth Literacy Concept
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.
Read the 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.
- Being tested
- experience learning programs of eHealth care
- Keywords
- Chronic disease, eHealth literacy, patient engagement, experience learning theory, Self-management, empowerment, eHealth care
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Cardiovascular Diseases, Chronic Disease, Patient Participation, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experience learning programs of eHealth careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| experience learning programs of eHealth care | Experimental | Patients in the experimental group received 6 sections of activities. Receives: Behavioral: experience learning programs of eHealth care |
| Usual care | No intervention | Patients in control group received usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The pretest is completed when the patients agrees to join the intervention.
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.
Measured: The post-test 1 is completed at the end of the 6 weeks intervention
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.
Measured: The post-test 2 is completed after intervention at 3 months
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.
Measured: The post-test 3 is completed after intervention at 6 months
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
Measured: The pretest is completed when the patients agrees to join the intervention.
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
Measured: The post-test 1 is completed at the end of the 6 weeks intervention
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
Measured: The post-test 2 is completed after intervention at 3 months
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
Measured: The post-test 3 is completed after intervention at 6 months
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.
Measured: The pretest is completed when the patients agrees to join the intervention.
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.
Measured: The post-test 1 is completed at the end of the 6 weeks intervention
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.
Measured: The post-test 2 is completed after intervention at 3 months
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.
Measured: The post-test 3 is completed after intervention at 6 months
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.
Measured: The pretest is completed when the patients agrees to join the intervention.
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.
Measured: The post-test 1 is completed at the end of the 6 weeks intervention
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.
Measured: The post-test 2 is completed after intervention at 3 months
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.
Measured: The post-test 3 is completed after intervention at 6 months
Secondary outcomes (8)
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) .
Measured: To collect two-time point data by chart review. Those were before the intervention and the end of the the 6 weeks intervention
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) .
Measured: 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
The change in HbA1C level at the end of the intervention
The health outcome indicator of management of diabetes
Measured: To collect two-time point data by chart review. Those were before the intervention and the end of the the 6 weeks intervention
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
Measured: 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
The change in Triglycerides level at the end of the intervention
The health outcome indicator of management of lipid
Measured: To collect two-time point data by chart review. Those were before the intervention and the end of the six weeks intervention
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
Measured: 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.
The change in Cholesterol level at the end of the intervention
The health outcome indicator of management of lipid
Measured: To collect two-time point data by chart review. Those were before the intervention and the end of the 6 weeks intervention
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Aug 2019
- Primary completion31 Jul 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chi Chen, National Yang Ming Chiao Tung University
- Investigators
- Yu-Chi Chen, Ph.D., Study chair, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180604
- Sponsor's protocol ID
- MOST-107-2314-B-010-014-MY3
- Acronym
- eHL
- Status last verified
- Dec 2021
- First submitted
- 15 Nov 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29434011Graffigna 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.
PubMed 25870566Kayser 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.
PubMed 27025228Richtering 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.
PubMed 28448497Schillinger 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.
PubMed 32593981Alpay 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.
PubMed 22193825Knight 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.
PubMed 25295771Kreps 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.
PubMed 20202779Cheng YS, Lin CP, Chen LA, Hwang WR, Lin YC, Chen YC. Short-Term Effects of an eHealth Care Experiential Learning Program Among Patients With Type 2 Diabetes: Randomized Controlled Trial. J Med Internet Res. 2024 Aug 16;26:e53509. doi: 10.2196/53509.
PubMed 39150761
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patients With Chronic Disease to Engage in the eHealth Care Environment: the Application and Evaluation of eHealth Literacy Concept
- ClinicalTrials.gov ID
- NCT05180604
- Acronym / sponsor ID
- eHL / MOST-107-2314-B-010-014-MY3
- Keywords
- Chronic disease, eHealth literacy, patient engagement, experience learning theory, Self-management, empowerment, eHealth care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experience learning programs of eHealth care | Experimental | Behavioral: experience learning programs of eHealth carePatients in the experimental group received 6 sections of activities. |
| Usual care | No intervention | –Patients in control group received usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experience learning programs of eHealth careThe 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 | Behavioural | experience learning programs of eHealth care |
Primary outcome
Baseline of eHealth Literacy Questionnaire scores
Time frame: The pretest is completed when the patients agrees to join the 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 at the end of intervention
Time frame: The post-test 1 is completed at the end of the 6 weeks 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
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.
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.
Baseline of The acceptance of eHealth care scores
Time frame: The pretest is completed when the patients agrees to join the 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 at the end of intervention
Time frame: The post-test 1 is completed at the end of the 6 weeks 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
Time frame: The post-test 2 is completed 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
Time frame: The post-test 3 is completed 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
Time frame: The pretest is completed when the patients agrees to join the 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 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.
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 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.
Baseline of Patient Health Engagement score
Time frame: The pretest is completed when the patients agrees to join 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 at the end of the intervention
Time frame: The post-test 1 is completed at the end of the 6 weeks 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
Time frame: The post-test 2 is completed 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
Time frame: The post-test 3 is completed 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.
8 secondary outcomes
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
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
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
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
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
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Results publication: PubMed 29434011Kayser 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 publication: PubMed 25870566Graffigna 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 publication: PubMed 27025228Kayser 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 publication: PubMed 28448497Richtering 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 publication: PubMed 32593981Schillinger 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 publication: PubMed 22193825Alpay 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 publication: PubMed 25295771Knight 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 publication: PubMed 20202779Kreps 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.
- Derived from this study: PubMed 39150761Cheng YS, Lin CP, Chen LA, Hwang WR, Lin YC, Chen YC. Short-Term Effects of an eHealth Care Experiential Learning Program Among Patients With Type 2 Diabetes: Randomized Controlled Trial. J Med Internet Res. 2024 Aug 16;26:e53509. doi: 10.2196/53509.
- A Multidimensional Tool Based on the eHealth Literacy Framework: Development and Initial Validity Testing of the eHealth Literacy Questionnaire (eHLQ)Link provided by the sponsor.
- Measuring patient engagement: development and psychometric properties of the Patient Health Engagement (PHE) Scale.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chi Chen, Ph.D. study chair
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experience learning programs of eHealth care in people with Type 2 Diabetes Mellitus and Chronic Kidney Diseases, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline of eHealth Literacy Questionnaire scores (time frame: The pretest is completed when the patients agrees to join the intervention.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180604, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.