Diabetes Mellitus, Type 2NCT05992545
Mobile Application for Integrative Diabetes Care
A study of Diabetes Mellitus, Type 2 and Depression, run by Korea University Anam Hospital at 2 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Depression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 13 Jun 2022to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Korea University Anam Hospital
Seoul, 02841
Korea University Anam Hospital
Seoul
About this study
Official title: Diabetes Care Via a Mobile Application on Integrating Physical and Mental Health: A Pilot Study
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.
- Conditions
- Diabetes Mellitus, Type 2, Depression
- Being tested
- Mobile application 'DangDang Care' under usual care
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application 'DangDang Care' under usual careDevice
Also called DangDang 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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application 'DangDang Care' under usual care | Experimental | The intervention group receives 'DangDang Care' alongside usual diabetes care. Receives: Device: Mobile application 'DangDang Care' under usual care |
| Usual care | No intervention | The control group receives only usual diabetes care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: By week 12
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.
Measured: By week 12
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.
Measured: By week 12
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.
Measured: By week 12
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.
Measured: By week 12
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.
Measured: By week 12
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.
Measured: By week 12
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.
Measured: By week 12
Secondary outcomes (3)
Changes in glycated hemoglobin (%)
Measures average blood glucose levels over the past 2-3 months through venous blood sampling.
Measured: By week 12
Changes in fasting plasma glucose levels (mg/dL)
Measures glucose levels after an 8-hour fasting period through venous blood sampling.
Measured: By week 12
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.
Measured: By week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start13 Jun 2022
- Primary completion13 Jan 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bae, Jae Hyun, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992545
- Sponsor's protocol ID
- DangDangCare
- Status last verified
- Aug 2023
- First submitted
- 23 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Care Via a Mobile Application on Integrating Physical and Mental Health: A Pilot Study
- ClinicalTrials.gov ID
- NCT05992545
- Acronym / sponsor ID
- DangDangCare
- Conditions
- Diabetes Mellitus, Type 2, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile application 'DangDang Care' under usual care | Experimental | Device: Mobile application 'DangDang Care' under usual careThe intervention group receives 'DangDang Care' alongside usual diabetes care. |
| Usual care | No intervention | –The control group receives only usual diabetes care. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application 'DangDang Care' under usual careAlso: DangDang CareThe 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. | Device | Mobile application 'DangDang Care' under usual care |
Primary outcome
Changes in Patient Health Questionnaire-9 (PHQ-9) scores
Time frame: By week 12
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.
Changes in Generalized Anxiety Disorder-7 (GAD-7) scores
Time frame: By week 12
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.
Changes in Korean version of the Perceived Stress Scale (K-PSS) scores
Time frame: By week 12
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.
Changes in Brief Diabetes Distress Screening Instrument (DDS-2) scores
Time frame: By week 12
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.
Changes in European Quality of Life-5 Dimensions 3 Level (EQ-5D-3L) index
Time frame: By week 12
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.
Changes in Diabetes Self-Efficacy Scale (DSES) scores
Time frame: By week 12
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.
Changes in Diabetes Care Profile-Social Support Scale (DCP-SSS) scores
Time frame: By week 12
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.
Changes in Diabetes Self-Management Behaviors for Older Koreans (DSMB-O) scores
Time frame: By week 12
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.
3 secondary outcomes
Changes in glycated hemoglobin (%)
Time frame: By week 12
Changes in fasting plasma glucose levels (mg/dL)
Time frame: By week 12
Change in lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol (mg/dL)
Time frame: By week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus, Type 2 and Depression, run by Korea University Anam Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Patient Health Questionnaire-9 (PHQ-9) scores (time frame: By week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.