Development of Health Monitoring System on Patient's Well Being in Dialysis Context

Quality of Life Clinical Trial

— SIKIDI  

Official title:

Design and Development of Health Monitoring System on Quality of Life, Self-management and Self-efficacy Among Patients Undergoing Hemodialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306859
• Other study ID #: SIKIDI 2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Universitas Muhammadiyah Yogyakarta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the goals in the Sustainable Development Goals (SDGs) is the availability of a healthy and prosperous life for all ages. This goal mentions health priorities i.e. non-communicable diseases. Chronic kidney failure (CRF) is one of the non-communicable diseases that is the main cause of death and disability both in the world and in Indonesia. The prevalence of CRF in Indonesia is 0.5% with 83.2% of patients being of productive age and the highest number of CRF patients in North Kalimantan, Southeast Sulawesi, DKI Jakarta and Yogyakarta. Monitoring and evaluation of patients with CRF is currently mostly carried out conventionally not using health technology that is integrated with hospital information systems. This study aims to design and provide a health information system for patients with CRF, hereinafter referred to as SIKIDI, which integrates mobile-health applications used independently by patients with existing information systems in hospitals.

Description:

One of the goals in the Sustainable Development Goals (SDGs) is the availability of a healthy and prosperous life for all ages. This goal mentions health priorities i.e. non-communicable diseases. Chronic kidney failure (CRF) is one of the non-communicable diseases that is the main cause of death and disability both in the world and in Indonesia. The prevalence of CRF in Indonesia is 0.5% with 83.2% of patients being of productive age and the highest number of CRF patients in North Kalimantan, Southeast Sulawesi, DKI Jakarta and Yogyakarta. Monitoring and evaluation of patients with CRF is currently mostly carried out conventionally not using health technology that is integrated with hospital information systems. This study aims to design and provide a health information system for patients with CRF, hereinafter referred to as SIKIDI, which integrates mobile-health applications used independently by patients with existing information systems in hospitals.

This research is a multicenter basic research in four provinces. In the first year, the level of readiness and patient needs in using the mobile-health application will be seen. Furthermore, SIKIDI will be developed for monitoring the condition of patients integrated with existing systems in hospitals, and will be tested on patients with CRF at partner hospitals in DIY provinces. In addition, the ease and comfort of patients when using SIKIDI will also be seen. The output of the first year is publication in accredited national journals and prototypes of SIKIDI version 1.

In the second phase, SIKIDI version 2 will be developed which is equipped with educational features that are expected to increase patient knowledge in self-management. The trial process will be carried out at partner hospitals to see the effectiveness of educational features with patient self-management capabilities. The advantages of SIKIDI are: (1) integrated with hospital information systems; (2) include patients and families in condition monitoring; (3) improve the self-efficacy ability of patients and families. The output of year 2 is publication in reputable international journals and prototypes of SIKIDI version 2.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• >18 years old

• has been undergoing hemodialysis >3 months

• has smartphone

Exclusion Criteria:

• emergency hemodialysis

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• M-health
• Quality of Life
• Renal Insufficiency, Chronic
• Self Efficacy

Intervention

Behavioral:
• Using m-health for monitoring and education provision
The intervention group will be given access to m-health. The m-health aims to monitor patient's status i.e blood pressure, heart rate, fluid intake, dietary intake. In addition, there will be education provided through the m-health. The education will be on fluid and diet adherence

Other:
• Standard care
The comparator group will be given standard and routine care

Locations

Country	Name	City	State
Indonesia	RS PKU Muhammadiyah Bantul	Bantul	Yogy

Sponsors (2)

Lead Sponsor	Collaborator
Universitas Muhammadiyah Yogyakarta	Ministry of Education Culture, Research and Technology

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life that will be measured using KDQOL before and after intervention	The quality of life will be measured using Kidney Disease Quality of Life, (KDQOL) before and after the intervention. The max score is 100 and minimum score is 50	four weeks
Secondary	Self-efficacy that will be measured using CKD SE before and after	The self-efficacy will be measured using validated tool CKD Self-Efficaccy (CKD SE). The maximum score is 100, and the minimum score is 0	four weeks