NCT07515677

Brief Summary

Diabetes mellitus is a chronic disease that requires continuous self-management to prevent complications and hospital readmissions. However, discharge planning in many hospitals is often delivered verbally and lacks structured follow-up after patients return home, which may lead to poor self-management behaviors. This study aims to evaluate the effectiveness of a digital discharge planning intervention delivered through a mobile application to improve self-management among patients with diabetes mellitus after hospital discharge. The intervention is based on the Chronic Care Model and includes educational materials, reminders, and monitoring tools related to seven dimensions of diabetes self-management. A randomized controlled trial with a parallel-group design will be conducted among patients with diabetes mellitus. Participants in the intervention group will receive digital discharge planning through a mobile application for 90 days after discharge, while the control group will receive standard discharge planning provided by the hospital. Primary outcomes include patient self-management behavior, while secondary outcomes include glycemic control and hospital readmission within 90 days.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Apr 2026Nov 2026

First Submitted

Initial submission to the registry

March 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

March 31, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

Diabetes Self-ManagementDigital Health InterventionDischarge PlanningMobile Health

Outcome Measures

Primary Outcomes (1)

  • Change in diabetes self-management score

    Diabetes self-management will be assessed using an adapted Indonesian version of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire consisting of 21 items across seven domains (healthy eating, physical activity, blood glucose monitoring, medication adherence, problem solving, risk reduction, and healthy coping). Each item is scored on a 5-point Likert scale (1-5) reflecting frequency of behavior during the past 7 days. Total scores range from 21 to 105, with higher scores indicating better diabetes self-management behavior.

    Baseline to 90 days after hospital discharge

Secondary Outcomes (2)

  • Change in HbA1c level

    Baseline to 90 days

  • Hospital readmission within 90 days

    Within 90 days after hospital discharge

Study Arms (2)

Digital Discharge Planning

EXPERIMENTAL

Participants receive digital discharge planning through a mobile application for 90 days after hospital discharge.

Behavioral: Digital Discharge Planning Application

Standard Discharge Planning

ACTIVE COMPARATOR

Participants receive standard discharge planning routinely provided by the hospital.

Behavioral: Standard Discharge Planning

Interventions

A mobile health application designed to support diabetes self-management after hospital discharge, including education, reminders, and monitoring tools for 90 days.

Digital Discharge Planning

Participants receive standard discharge planning routinely provided by the hospital according to usual care procedures.

Standard Discharge Planning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with diabetes mellitus.
  • Age 18 years or older.
  • Hospitalized patients who are preparing for discharge.
  • Able to use a smartphone and access the mobile application.
  • Willing to participate and provide informed consent.

You may not qualify if:

  • Patients with severe complications requiring intensive care.
  • Patients with cognitive impairment or severe mental illness that may interfere with participation.
  • Patients who are unable to operate a smartphone or mobile application.
  • Patients who decline to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RS Universitas Sebelas Maret

Sukoharjo, Central Java, 57557, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Ririn Kartika Novitasari

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study uses a single-blind design in which the outcome assessor will be blinded to the group allocation. Participants and investigators will be aware of the intervention due to the nature of the digital discharge planning intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an intervention group receiving digital discharge planning through a mobile application or a control group receiving standard discharge planning provided by the hospital. The intervention will be conducted for 90 days after hospital discharge.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Student, Nursing Science Program

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared due to privacy and confidentiality considerations. Data may be available from the principal investigator upon reasonable request.

Locations