Empowerment-based Complementary and Alternative Medicine (ECAM)

Diabetes Clinical Trial

— CAM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317584
• Other study ID #: NMRPF3M0042
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Chang Gung University of Science and Technology
• Contact: Chang Hsiao Yun, PhD
• Phone: 03-2118999
• Email: hychang[@]mail.cgust.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: July 31, 2025
• Est. primary completion date: March 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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
• 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

Locations

Country	Name	City	State
Taiwan	CHENG GUNG MEMORIAL HOSPITAL, Linkou	Taoyuan City	Guishan District

Sponsors (3)

Lead Sponsor	Collaborator
Chang Gung University of Science and Technology	Chang Gung Memorial Hospital, National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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