Mobile Application for Integrative Diabetes Care

NCT ID: NCT05992545

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2023-07-21

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mobile application 'DangDang Care' under usual care

The intervention group receives 'DangDang Care' alongside usual diabetes care.

Group Type EXPERIMENTAL

Mobile application 'DangDang Care' under usual care

Intervention Type DEVICE

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.

Usual care

The control group receives only usual diabetes care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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DangDang Care

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bae, Jae Hyun

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Korea University Anam Hospital

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DangDangCare

Identifier Type: -

Identifier Source: org_study_id

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