Mobile Application for Integrative Diabetes Care

Depression Clinical Trial

Official title:

Diabetes Care Via a Mobile Application on Integrating Physical and Mental Health: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05992545
• Other study ID #: DangDangCare
• Status: Completed
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: August 2023
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators have developed a mobile application named 'DangDang Care' (which conveys the meaning of managing diabetes confidently and consistently through psychological care) designed to provide psychological support and enhance diabetes self-management for people with type 2 diabetes experiencing depressive symptoms. The application incorporates a behavioral activation program. Subsequently, the investigators conducted a 12-week randomized controlled trial, enrolling individuals with type 2 diabetes and mild-to-moderate depression, with the assistance of public health centers. The trial aimed to assess the effectiveness and feasibility of the application in promoting consistent diabetes management through added psychological care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 21, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults aged 20 to 80 years with type 2 diabetes
• Individuals belonging to disadvantaged populations, such as medical aid beneficiaries or those classified as low-income groups
• Mild-to-moderate depressive symptoms, defined as a Patient Health Questionnaire-9 (PHQ-9) score between 5 and 19
• Capable of reading and understanding Korean and using a mobile application
• Having a clear understanding of the study's purpose and providing written consent

Exclusion Criteria:

• Type 1 diabetes or gestational diabetes
• Diabetes complications that hindered diabetes self-management
• Severe depressive symptoms that made app usage and completion of the self-report questionnaire difficult
• Serious mental illnesses other than depressive symptoms (e.g., schizophrenia and related disorders, bipolar and related disorders, or neurodegenerative disorders)
• Serious life-threatening medical conditions
• Physical conditions that impeded mobility
• A history of traumatic brain injury
• Unwillingness to complete the questionnaire and provide personal information

Related Conditions & MeSH terms

• Depression
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Mobile application 'DangDang Care' under usual care
The application incorporates a behavioral activation program to provide psychological support and enhance diabetes self-management for people with type 2 diabetes experiencing depressive symptoms, alongside conventional medical therapy. The intervention group receives the mobile application with usual care.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Persistent changes in Patient Health Questionnaire-9 (PHQ-9) scores	The PHQ-9 is a 9-item self-report scale developed to assess the presence and severity of depression within the past 2 weeks. It was adapted for use with Korean participants. Respondents rate how often they have been bothered by each problem on a 4-point Likert scale ranging from 0 to 3. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms, and a cutoff score of 10 is used.	By week 16
Other	Persistent changes in Generalized Anxiety Disorder-7 (GAD-7) scores	The GAD-7 is a brief self-report scale that assesses generalized anxiety disorder, comprising 7 items. Respondents rate the frequency of experiencing symptoms related to generalized anxiety disorder over the past 2 weeks using a 4-point Likert scale ranging from 0 to 3. Total scores range from 0 to 21, with higher scores indicating more severe anxiety. In this study, we used the Korean version of the GAD-7, accessible on the Patient Health Questionnaire website.	By week 16
Other	Persistent changes in Korean version of the Perceived Stress Scale (K-PSS) scores	The Perceived Stress Scale (PSS), originally developed in 1983, was translated into Korean in 2010 and 2012. The K-PSS consists of 10 items, and respondents rate their responses on a 5-point Likert scale ranging from 0 to 4. The total score ranges from 0 to 40, with higher scores indicating higher perceived stress levels.	By week 16
Other	Persistent changes in Brief Diabetes Distress Screening Instrument (DDS-2) scores	The DDS-2 is a brief version of the Diabetes Distress Scale, developed in 2008, and was translated into Korean in 2020. It consists of 2 items, and each item assesses the emotional burden of diabetes and the stress of diabetes management and treatment on a 6-point Likert scale ranging from 1 to 6. The total score ranges from 2 to 12, with higher scores indicating higher levels of diabetes-related stress.	By week 16
Other	Persistent changes in European Quality of Life-5 Dimensions 3 Level (EQ-5D-3L) index	The EQ-5D-3L is a tool developed by the Euro Quality of Life Group to assess health-related quality of life. It comprises a descriptive system with five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents rate their current health state within each domain using three levels. The evaluative system included the EQ-5D-3L index. We employed the EQ-5D-3L index to calculate utility values for health states and evaluate the overall quality of life.	By week 16
Other	Persistent changes in Diabetes Self-Efficacy Scale (DSES) scores	The DSES, originally developed by the Stanford Patient Education Research Center in 2009, was used in its Korean version translated by Young Sun Yeom in her thesis in 2010. It comprises 8 items, and respondents rate their level of confidence in successfully performing self-care behaviors on a 10-point Likert scale ranging from 1 to 10. Higher scores indicate a higher level of self-efficacy in managing diabetes.	By week 16
Other	Persisent changes in Diabetes Care Profile-Social Support Scale (DCP-SSS) scores	The Diabetes Care Profile (DCP), developed in 1996, measures psychosocial factors and diabetes treatment. For this study, only the instrumental and emotional support subscales were utilized, and they were translated into Korean in 2007. The scale was modified to fit the study's purpose, resulting in a total of 9 items, excluding 3 items not relevant to the study. Each item was answered on a 5-point Likert scale from 1 to 5, with higher scores indicating higher perceived social support.	By week 16
Other	Persistent changes in Diabetes Self-Management Behaviors for Older Koreans (DSMB-O) scores	The DSMB-O was developed in 2016 and is based on the self-management standards proposed by the American Association of Diabetes Educators, considering the characteristics of older adults with type 2 diabetes in Korea. The scale consists of a total of 14 questions, with 9 questions answered on a 4-point Likert scale from 0 to 3, and 5 dichotomous questions. The total score ranges from 0 to 30, with higher scores indicating higher levels of diabetes self-care behaviors.	By week 16
Primary	Changes in Patient Health Questionnaire-9 (PHQ-9) scores	The PHQ-9 is a 9-item self-report scale developed to assess the presence and severity of depression within the past 2 weeks. It was adapted for use with Korean participants. Respondents rate how often they have been bothered by each problem on a 4-point Likert scale ranging from 0 to 3. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms, and a cutoff score of 10 is used.	By week 12
Primary	Changes in Generalized Anxiety Disorder-7 (GAD-7) scores	The GAD-7 is a brief self-report scale that assesses generalized anxiety disorder, comprising 7 items. Respondents rate the frequency of experiencing symptoms related to generalized anxiety disorder over the past 2 weeks using a 4-point Likert scale ranging from 0 to 3. Total scores range from 0 to 21, with higher scores indicating more severe anxiety. In this study, we used the Korean version of the GAD-7, accessible on the Patient Health Questionnaire website.	By week 12
Primary	Changes in Korean version of the Perceived Stress Scale (K-PSS) scores	The Perceived Stress Scale (PSS), originally developed in 1983, was translated into Korean in 2010 and 2012. The K-PSS consists of 10 items, and respondents rate their responses on a 5-point Likert scale ranging from 0 to 4. The total score ranges from 0 to 40, with higher scores indicating higher perceived stress levels.	By week 12
Primary	Changes in Brief Diabetes Distress Screening Instrument (DDS-2) scores	The DDS-2 is a brief version of the Diabetes Distress Scale, developed in 2008, and was translated into Korean in 2020. It consists of 2 items, and each item assesses the emotional burden of diabetes and the stress of diabetes management and treatment on a 6-point Likert scale ranging from 1 to 6. The total score ranges from 2 to 12, with higher scores indicating higher levels of diabetes-related stress.	By week 12
Primary	Changes in European Quality of Life-5 Dimensions 3 Level (EQ-5D-3L) index	The EQ-5D-3L is a tool developed by the Euro Quality of Life Group to assess health-related quality of life. It comprises a descriptive system with five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents rate their current health state within each domain using three levels. The evaluative system included the EQ-5D-3L index. We employed the EQ-5D-3L index to calculate utility values for health states and evaluate the overall quality of life.	By week 12
Primary	Changes in Diabetes Self-Efficacy Scale (DSES) scores	The DSES, originally developed by the Stanford Patient Education Research Center in 2009, was used in its Korean version translated by Young Sun Yeom in her thesis in 2010. It comprises 8 items, and respondents rate their level of confidence in successfully performing self-care behaviors on a 10-point Likert scale ranging from 1 to 10. Higher scores indicate a higher level of self-efficacy in managing diabetes.	By week 12
Primary	Changes in Diabetes Care Profile-Social Support Scale (DCP-SSS) scores	The Diabetes Care Profile (DCP), developed in 1996, measures psychosocial factors and diabetes treatment. For this study, only the instrumental and emotional support subscales were utilized, and they were translated into Korean in 2007. The scale was modified to fit the study's purpose, resulting in a total of 9 items, excluding 3 items not relevant to the study. Each item was answered on a 5-point Likert scale from 1 to 5, with higher scores indicating higher perceived social support.	By week 12
Primary	Changes in Diabetes Self-Management Behaviors for Older Koreans (DSMB-O) scores	The DSMB-O was developed in 2016 and is based on the self-management standards proposed by the American Association of Diabetes Educators, considering the characteristics of older adults with type 2 diabetes in Korea. The scale consists of a total of 14 questions, with 9 questions answered on a 4-point Likert scale from 0 to 3, and 5 dichotomous questions. The total score ranges from 0 to 30, with higher scores indicating higher levels of diabetes self-care behaviors.	By week 12
Secondary	Changes in glycated hemoglobin (%)	Measures average blood glucose levels over the past 2-3 months through venous blood sampling.	By week 12
Secondary	Changes in fasting plasma glucose levels (mg/dL)	Measures glucose levels after an 8-hour fasting period through venous blood sampling.	By week 12
Secondary	Change in lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol (mg/dL)	Measures total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) after an 8-hour fasting period through venous blood sampling.	By week 12