Empowerment-based Complementary and Alternative Medicine (ECAM) (CAM)

The Establishment of "Empowerment-based Complementary and Alternative Medicine (ECAM) " Educational Program to Improve Complementary and Alternative Medicine(CAM) Health Literacy in Patients With Diabetes: Dilemma Analysis, Integration Into Practice and Outcome Evaluation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes
• Intervention / Treatment: Other: Experimental: Empowerment Application for CAM Health Education; Other: Written Paper for CAM Health Education

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.

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang Hsiao Yun, PhD; Phone Number: 3321 03-2118999; Email: hychang@mail.cgust.edu.tw

Study Locations

• Taiwan
  • Guishan District
    • Taoyuan City, Guishan District, Taiwan, 333
      • CHENG GUNG MEMORIAL HOSPITAL, Linkou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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
Placebo Comparator: Written Paper for CAM Health Education.; 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; Using written paper for complementary and alternative therapy education and explaining the risk factors that need to be considered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 minimum and maximum values，and higher scores .The minimum is 16，maximum values is 64，The lower the score, the poorer the understanding.	Pre-test (baseline), 2, 3 months after intervention
Quality of life questionnaire	Measure patients' understanding of benefit-risk management on CAM use, the minimum and maximum values，and higher scores .The minimum is 7，maximum values is 105，The lower the score, the poorer the understanding.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glucose (GLU)	Normal blood glucose levels typically range between 70 and 100 milligrams per deciliter (mg/dL) when fasting (not having eaten for at least 8 hours).	Pre-test (baseline),3 months after intervention
Glycated Hemoglobin(HbA1c)	Glycated Hemoglobin, or hemoglobin A1c, is a measure of average blood glucose levels over the past two to three months. An average HbA1c level is below 5.7%, while levels between 5.7% and 6.4% may indicate prediabetes, and levels of 6.5% or higher usually indicate diabetes.	Pre-test (baseline),3 months after intervention
ALanine aminoTransferase，Glutamic Pyruvic Transaminase(ALT/GPT)	Normal ranges for alanine aminotransferase and glutamic pyruvic transaminase levels can vary depending on the laboratory and the individual's age, sex, and health status. Typically, normal ALT/GPT levels are below 40 international units per liter (IU/L) for men and below 35 IU/L for women. Persistent elevation of ALT/GPT levels may warrant further investigation to determine the underlying cause and appropriate management.	Pre-test (baseline),3 months after intervention
ASpartate aminoTransferase，Glutamic Oxaloacetic Transaminase (AST/GOT)	normal aspartate aminotransferase，glutamic oxaloacetic transaminase levels are below 40 international units per liter (IU/L) for men and women. Persistent elevation of AST/GOT levels may indicate underlying health issues and may require further evaluation to determine the cause and appropriate management.	Pre-test (baseline),3 months after intervention
Blood Urea Nitrogen(BUN)	Normal blood urea nitrogen levels generally fall within the range of 7 to 20 milligrams per deciliter (mg/dL) in adults. Still, this range can vary depending on factors such as age, sex, and underlying health conditions. Interpretation of BUN levels should be done in conjunction with other clinical findings and additional tests to determine the underlying cause and guide appropriate treatment.	Pre-test (baseline),3 months after intervention
Creatinine(CREA)	Normal creatinine levels can vary depending on factors such as age, sex, muscle mass, and ethnicity. Generally, normal creatinine levels fall within the following ranges: For adult men: 0.6 to 1.2 milligrams per deciliter (mg/dL) For adult women: 0.5 to 1.1 mg/dL	Pre-test (baseline),3 months after intervention
High Density Lipoprotein(HDL)	Normal high-density lipoprotein cholesterol levels are generally considered to be: Above 60 milligrams per deciliter (mg/dL) is considered high and is associated with a lower risk of heart disease. Below 40 mg/dL for men and below 50 mg/dL for women is considered low and may increase the risk of heart disease.	Pre-test (baseline),3 months after intervention
Total Bilirubin(T.BIL)	Normal total bilirubin levels typically range from 0.3 to 1.2 milligrams per deciliter (mg/dL) in adults.	Pre-test (baseline),3 months after intervention
Serum total cholesterol(TC)	Average total cholesterol levels vary depending on factors such as age, sex, and individual health status. Generally, total cholesterol levels below 200 milligrams per deciliter (mg/dL) are considered desirable. In contrast, levels between 200 and 239 mg/dL are borderline high, and levels above 240 mg/dL are considered high and may increase the risk of heart disease.	Pre-test (baseline),3 months after intervention
Triglyceride (TG)	Normal triglyceride levels typically fall below 150 milligrams per deciliter (mg/dL) in adults. Triglyceride levels between 150 and 199 mg/dL are considered borderline high, levels between 200 and 499 mg/dL are considered high, and levels of 500 mg/dL or above are considered very high.	Pre-test (baseline),3 months after intervention
Glomerular filtration rate(GFR)	Normal glomerular filtration rate levels vary depending on factors such as age, sex, and body size. In adults, a GFR above 90 mL/min/1.73 m² is generally considered normal, while values below this range may indicate decreased kidney function. GFR values below 60 mL/min/1.73 m² for three months or longer are indicative of chronic kidney disease (CKD).	Pre-test (baseline),3 months after intervention
Albumin to Creatinine Ratio (ACR)	Normal albumin to creatinine ratio levels are typically less than 30 mg/g. ACR levels between 30 and 300 mg/g are considered moderately elevated, and levels above 300 mg/g are considered severely elevated.	Pre-test (baseline),3 months after intervention

Collaborators and Investigators

• Sponsor: Chang Gung University of Science and Technology
• Collaborators: Chang Gung Memorial Hospital; National Science and Technology Council
• Investigators: Study Chair: Chang Hsiao Yun, PhD, Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 4, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Complementary and Alternative Medicine (CAM); Health Literacy; Empowerment; Patient Education; Application
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: NMRPF3M0042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No