Empowerment-based Complementary and Alternative Medicine (ECAM)

NCT06317584 | Completed

• 1 other identifier: NMRPF3M0042
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Complementary and Alternative Medicine (CAM); Patient Education; Empowerment; Health Literacy; Application; Diabetes

Outcome Measures

Primary Outcomes (3)

• Understanding the benefits-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire

  Measure patients' understanding of benefit-risk management on CAM use，The lower the score, the poorer the understanding.

  Pre-test (baseline), 2, 3 months after intervention

• Quality of life questionnaire

  assess patients' satisfaction with various aspects of life while managing diabetes.

  Pre-test (baseline), 2, 3 months after intervention

• Diabetes Empowerment scale

  Measure patients' understanding of benefit-risk management on CAM use, the minimum and maximum values，and higher scores .The minimum is 10，maximum values is 40，The lower the score, the poorer the understanding.

  Pre-test (baseline), 2, 3 months after intervention

Study Arms (2)

Empowerment Application for CAM Health Education.

EXPERIMENTAL

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

Other: Experimental: Empowerment Application for CAM Health Education

Written Paper for CAM Health Education.

PLACEBO COMPARATOR

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

Other: Written Paper for CAM Health Education

Interventions

Experimental: Empowerment Application for CAM Health Education 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

Empowerment Application for CAM Health Education.

Written Paper for CAM Health Education OTHER

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

Written Paper for CAM Health Education.

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead
• National Science and Technology Council: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

CHENG GUNG MEMORIAL HOSPITAL, Linkou

Taoyuan, Guishan District, 333, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Empowerment

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior; Behavior

Study Officials

• Chang Hsiao Yun, PhD

  Chang Gung University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The process of keeping the study group assignment hidden after the allocation to participant, care provider, investigator, outcomes assessor
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Randomized trail method

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: May 17, 2024
• Primary Completion: August 16, 2024
• Study Completion: January 3, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)