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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Chronic Kidney Diseases; Self Efficacy; M-health
• Intervention / Treatment: Behavioral: Using m-health for monitoring and education provision; Other: Standard care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Yogy
    • Bantul, Yogy, Indonesia, 55183
      • RS PKU Muhammadiyah Bantul
      • Contact: Indra Prasetyantori, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >18 years old
• has been undergoing hemodialysis >3 months
• has smartphone

Exclusion Criteria:

• emergency hemodialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIKIDI group; The experimental arm will be given to access to m-health to monitor and education provision.	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
Active Comparator: Comparator; The comparator group will be given standard care	Other: Standard care; The comparator group will be given standard and routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitas Muhammadiyah Yogyakarta
• Collaborators: Ministry of Education Culture, Research and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; chronic kidney disease; self efficacy
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: SIKIDI 2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be provided upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No