NCT05180604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

November 15, 2021

Last Update Submit

December 17, 2021

Conditions

Keywords

Chronic diseaseeHealth literacypatient engagementexperience learning theorySelf-managementempowermenteHealth care

Outcome Measures

Primary Outcomes (16)

  • Baseline of eHealth Literacy Questionnaire scores

    Evaluate the patient's eHL level, including 7 dimensions (1) Using technology to process health information, (2) Understanding of health concepts and languages, (3)Ability to actively engage with digital service, (4)Feel safe and in control, (5) Motivated to engage with digital service, (6) Access to digital services that work (7)Digital services that suit individual. The higher the score, the better the eHL.

    The pretest is completed when the patients agrees to join the intervention.

  • The eHealth Literacy Questionnaire scores at the end of intervention

    Evaluate the patient's eHL level, including 7 dimensions (1) Using technology to process health information, (2) Understanding of health concepts and languages, (3)Ability to actively engage with digital service, (4)Feel safe and in control, (5) Motivated to engage with digital service, (6) Access to digital services that work (7)Digital services that suit individual. The higher the score, the better the eHL.

    The post-test 1 is completed at the end of the 6 weeks intervention

  • The eHealth Literacy Questionnaire scores after intervention at 3 months

    Evaluate the patient's eHL level, including 7 dimensions (1) Using technology to process health information, (2) Understanding of health concepts and languages, (3)Ability to actively engage with digital service, (4)Feel safe and in control, (5) Motivated to engage with digital service, (6) Access to digital services that work (7)Digital services that suit individual. The higher the score, the better the eHL.

    The post-test 2 is completed after intervention at 3 months

  • The eHealth Literacy Questionnaire scores after intervention at 6 months

    Evaluate the patient's eHL level, including 7 dimensions (1) Using technology to process health information, (2) Understanding of health concepts and languages, (3)Ability to actively engage with digital service, (4)Feel safe and in control, (5) Motivated to engage with digital service, (6) Access to digital services that work (7)Digital services that suit individual. The higher the score, the better the eHL.

    The post-test 3 is completed after intervention at 6 months

  • Baseline of The acceptance of eHealth care scores

    The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device

    The pretest is completed when the patients agrees to join the intervention.

  • The acceptance of eHealth care scores at the end of intervention

    The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device

    The post-test 1 is completed at the end of the 6 weeks intervention

  • The acceptance of eHealth care scores after intervention at 3 months

    The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device

    The post-test 2 is completed after intervention at 3 months

  • The acceptance of eHealth care scores after intervention at 6 months

    The scale was developed base on Technology Acceptance Model to assess patients' behaviors intention of using the eHealth device

    The post-test 3 is completed after intervention at 6 months

  • Baseline of Health Technology Usage Sore

    Use self-developed structured questionnaires to investigate the types of health technology use and monitoring items. Use types include computer or network systems, mobile apps, health monitoring systems or wearable devices (such as pedometers, smart bracelets, heart rate monitors, blood pressure monitors, Blood glucose meter, blood pressure meter, blood glucose meter or weight scale, etc.) or other, monitoring items include blood pressure, blood sugar, weight, diet, sleep, heart rate, steps or other health data. The higher the number, the more items are monitored, the total score The higher the level, the better the use of health technology.

    The pretest is completed when the patients agrees to join the intervention.

  • The Health Technology Usage Sore at the end of intervention

    Use self-developed structured questionnaires to investigate the types of health technology use and monitoring items. Use types include computer or network systems, mobile apps, health monitoring systems or wearable devices (such as pedometers, smart bracelets, heart rate monitors, blood pressure monitors, Blood glucose meter, blood pressure meter, blood glucose meter or weight scale, etc.) or other, monitoring items include blood pressure, blood sugar, weight, diet, sleep, heart rate, steps or other health data. The higher the number, the more items are monitored, the total score The higher the level, the better the use of health technology.

    The post-test 1 is completed at the end of the 6 weeks intervention

  • The Health Technology Usage Sore after intervention at 3 months

    Use self-developed structured questionnaires to investigate the types of health technology use and monitoring items. Use types include computer or network systems, mobile apps, health monitoring systems or wearable devices (such as pedometers, smart bracelets, heart rate monitors, blood pressure monitors, Blood glucose meter, blood pressure meter, blood glucose meter or weight scale, etc.) or other, monitoring items include blood pressure, blood sugar, weight, diet, sleep, heart rate, steps or other health data. The higher the number, the more items are monitored, the total score The higher the level, the better the use of health technology.

    The post-test 2 is completed after intervention at 3 months

  • The Health Technology Usage Sore after intervention at 6 months

    Use self-developed structured questionnaires to investigate the types of health technology use and monitoring items. Use types include computer or network systems, mobile apps, health monitoring systems or wearable devices (such as pedometers, smart bracelets, heart rate monitors, blood pressure monitors, Blood glucose meter, blood pressure meter, blood glucose meter or weight scale, etc.) or other, monitoring items include blood pressure, blood sugar, weight, diet, sleep, heart rate, steps or other health data. The higher the number, the more items are monitored, the total score The higher the level, the better the use of health technology.

    The post-test 3 is completed after intervention at 6 months

  • Baseline of Patient Health Engagement score

    The scale is thought of as a self-administering tool by the patient in order to diagnose his/ her This scale has a total of 5 questions. The higher the number, the higher the patient engagement it is.

    The pretest is completed when the patients agrees to join the intervention.

  • The Patient Health Engagement score at the end of the intervention

    The scale is thought of as a self-administering tool by the patient in order to diagnose his/ her This scale has a total of 5 questions. The higher the number, the higher the patient engagement it is.

    The post-test 1 is completed at the end of the 6 weeks intervention

  • The Patient Health Engagement score after intervention at 3 months

    The scale is thought of as a self-administering tool by the patient in order to diagnose his/ her This scale has a total of 5 questions. The higher the number, the higher the patient engagement it is.

    The post-test 2 is completed after intervention at 3 months

  • The Patient Health Engagement score after intervention at 6 months

    The scale is thought of as a self-administering tool by the patient in order to diagnose his/ her This scale has a total of 5 questions. The higher the number, the higher the patient engagement it is.

    The post-test 3 is completed after intervention at 6 months

Secondary Outcomes (8)

  • The change in renal function level at the end of the intervention

    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

    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

    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

    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

    To collect two-time point data by chart review. Those were before the intervention and the end of the six weeks intervention

  • +3 more secondary outcomes

Study Arms (2)

experience learning programs of eHealth care

EXPERIMENTAL

Patients in the experimental group received 6 sections of activities.

Behavioral: experience learning programs of eHealth care

Usual care

NO INTERVENTION

Patients in control group received usual care

Interventions

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

experience learning programs of eHealth care

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming University

Taipei, Taiwan

Location

Related Publications (9)

  • 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.

  • Cheng 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Renal Insufficiency, ChronicCardiovascular DiseasesChronic DiseasePatient ParticipationEmpowerment

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSocial Behavior

Study Officials

  • Yu-Chi Chen, Ph.D.

    National Yang Ming Chiao Tung University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 15, 2021

First Posted

January 6, 2022

Study Start

August 1, 2019

Primary Completion

July 31, 2021

Study Completion

November 15, 2021

Last Updated

January 6, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations