Empowerment-based Complementary and Alternative Medicine (ECAM)

NCT ID: NCT06317584

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2025-01-03

Brief Summary

This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes.

Detailed Description

The objectives of this phase study are to (1) implement the ECAM educational app to empower patients with diabetes in their management of diabetes alongside CAM use; (2) examine the impact of the ECAM educational app on patient empowerment, CAM health literacy, risk management of CAM use, CAM communication and diabetes quality of life in patients with diabetes; and (3) collect feedback from both patients and nurses on how to improve the ECAM educational app for dissemination and implementation.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Empowerment Application for CAM Health Education.

Using empowerment software applications for complementary and alternative therapy education, explaining the risk factors that need to be considered, and teaching the use of the assistive tool of the empowerment software application

Group Type: EXPERIMENTAL

Experimental: Empowerment Application for CAM Health Education

Intervention Type: OTHER

Using empowerment software application for complementary and alternative therapy education, explaining the risk factors that need to be considered, and teaching the use of assistive tool of the empowerment software application

Written Paper for CAM Health Education.

Using written paper for complementary and alternative therapy education, explaining the risk factors that need to be considered

Group Type: PLACEBO_COMPARATOR

Written Paper for CAM Health Education

Intervention Type: OTHER

Using written paper for complementary and alternative therapy education and explaining the risk factors that need to be considered

Interventions

Experimental: Empowerment Application for CAM Health Education

Using empowerment software application for complementary and alternative therapy education, explaining the risk factors that need to be considered, and teaching the use of assistive tool of the empowerment software application

Intervention Type: OTHER

Written Paper for CAM Health Education

Using written paper for complementary and alternative therapy education and explaining the risk factors that need to be considered

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• People over the age of 20
• diagnosis of diabetes at least 12 months before the interview; and
• The use of CAM at least 3 months
• Sufficient mental ability to understand the informed consent form and sign it.

Exclusion Criteria

• Participants will be excluded by an assistant researcher if they serious physical condition and hard of hearing and seeing.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council

FED

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

Chang Gung University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Yun Chang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang Hsiao Yun, PhD

Role: STUDY_CHAIR

Chang Gung University of Science and Technology

Locations

CHENG GUNG MEMORIAL HOSPITAL, Linkou

Taoyuan, Guishan District, Taiwan

Countries

Taiwan

Other Identifiers

NMRPF3M0042

Identifier Type: -

Identifier Source: org_study_id