- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515677
Digital Discharge Planning to Improve Self-Management in Patients With Diabetes Mellitus (DDP-DM)
Effectiveness of a Digital Discharge Planning Intervention to Improve Self-Management in Patients With Diabetes Mellitus: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetes mellitus is one of the most prevalent chronic diseases worldwide and requires long-term self-management to maintain glycemic control and prevent complications. Effective discharge planning plays an important role in preparing patients to manage their condition independently after leaving the hospital. However, in many clinical settings, discharge planning is often delivered verbally and without structured follow-up, which may limit patients' ability to maintain appropriate self-management behaviors.
This study develops and evaluates a digital discharge planning model delivered through a mobile application to support patients with diabetes mellitus after hospital discharge. The intervention is theoretically grounded in the Chronic Care Model and supported by nursing theories including Orem's Self-Care Deficit Theory, Watson's Human Caring Theory, and Pender's Health Promotion Model.
The mobile application includes several features designed to support diabetes self-management based on the Diabetes Canada framework, including healthy eating, physical activity, blood glucose monitoring, medication adherence, problem solving, reducing risks, and healthy coping. The application provides educational materials, reminders, daily activity tracking, and feedback to encourage patient engagement and adherence to self-management practices.
A randomized controlled trial with a parallel-group design will be conducted to evaluate the effectiveness of the intervention. Participants will be randomly assigned to either the intervention group receiving digital discharge planning through the mobile application or the control group receiving standard discharge planning provided by the hospital. The intervention period will last for 90 days following hospital discharge. The study will assess the impact of the digital discharge planning model on self-management behaviors, glycemic control, and hospital readmission among patients with diabetes mellitus.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ririn Kartika Novitasari
- Phone Number: +6285728040905
- Email: j218240017@student.ums.ac.id
Study Locations
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-
Central Java
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Sukoharjo, Central Java, Indonesia, 57557
- RS Universitas Sebelas Maret
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Contact:
- Ririn Novitasari
- Phone Number: +6285728040905
- Email: j218240017@student.ums.ac.id
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital Discharge Planning
Participants receive digital discharge planning through a mobile application for 90 days after hospital discharge.
|
A mobile health application designed to support diabetes self-management after hospital discharge, including education, reminders, and monitoring tools for 90 days.
|
|
Active Comparator: Standard Discharge Planning
Participants receive standard discharge planning routinely provided by the hospital.
|
Participants receive standard discharge planning routinely provided by the hospital according to usual care procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in diabetes self-management score
Time Frame: Baseline to 90 days after hospital discharge
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HbA1c level
Time Frame: Baseline to 90 days
|
Glycemic control will be assessed by measuring glycated hemoglobin (HbA1c) levels before the intervention and at the end of the 90-day follow-up period.
|
Baseline to 90 days
|
|
Hospital readmission within 90 days
Time Frame: Within 90 days after hospital discharge
|
Hospital readmission due to diabetes-related complications within 90 days after discharge will be recorded from hospital records.
|
Within 90 days after hospital discharge
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPD-DM-RCT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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