Clinical trial NCT05992545: Mobile Application for Integrative Diabetes Care
Official title: Diabetes Care Via a Mobile Application on Integrating Physical and Mental Health: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Depression
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Patient Health Questionnaire-9 (PHQ-9) scores
timeFrame: By week 12
measure: Changes in Generalized Anxiety Disorder-7 (GAD-7) scores
timeFrame: By week 12
measure: Changes in Korean version of the Perceived Stress Scale (K-PSS) scores
timeFrame: By week 12
measure: Changes in Brief Diabetes Distress Screening Instrument (DDS-2) scores
timeFrame: By week 12
measure: Changes in European Quality of Life-5 Dimensions 3 Level (EQ-5D-3L) index
timeFrame: By week 12
measure: Changes in Diabetes Self-Efficacy Scale (DSES) scores
timeFrame: By week 12
measure: Changes in Diabetes Care Profile-Social Support Scale (DCP-SSS) scores
timeFrame: By week 12
measure: Changes in Diabetes Self-Management Behaviors for Older Koreans (DSMB-O) scores
timeFrame: By week 12
Secondary outcomes:
measure: Changes in glycated hemoglobin (%)
timeFrame: By week 12
measure: Changes in fasting plasma glucose levels (mg/dL)
timeFrame: By week 12
measure: Change in lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol (mg/dL)
timeFrame: By week 12
Other outcomes:
measure: Persistent changes in Patient Health Questionnaire-9 (PHQ-9) scores
timeFrame: By week 16
measure: Persistent changes in Generalized Anxiety Disorder-7 (GAD-7) scores
timeFrame: By week 16
measure: Persistent changes in Korean version of the Perceived Stress Scale (K-PSS) scores
timeFrame: By week 16
measure: Persistent changes in Brief Diabetes Distress Screening Instrument (DDS-2) scores
timeFrame: By week 16
measure: Persistent changes in European Quality of Life-5 Dimensions 3 Level (EQ-5D-3L) index
timeFrame: By week 16
measure: Persistent changes in Diabetes Self-Efficacy Scale (DSES) scores
timeFrame: By week 16
measure: Persisent changes in Diabetes Care Profile-Social Support Scale (DCP-SSS) scores
timeFrame: By week 16
measure: Persistent changes in Diabetes Self-Management Behaviors for Older Koreans (DSMB-O) scores
timeFrame: By week 16
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References: