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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06306859
Acronym
SIKIDI
Enrollment
30
Registered
2024-03-12
Start date
2024-03-15
Completion date
2024-12-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Quality of life, self efficacy, chronic kidney disease

Brief 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.

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.

Interventions

BEHAVIORALUsing 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

OTHERStandard care

The comparator group will be given standard and routine care

Sponsors

Ministry of Education Culture, Research and Technology
CollaboratorUNKNOWN
Universitas Muhammadiyah Yogyakarta
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The sample will be divided based on the schedule of hemodialysis. Intervention group will be chosen from Monday-Thursday.

Intervention model description

The intervention group will be given access to m-health to monitor and education provision for about four weeks

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* \>18 years old * has been undergoing hemodialysis \>3 months * has smartphone

Exclusion criteria

* emergency hemodialysis

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life that will be measured using KDQOL before and after interventionfour weeksThe 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

Secondary

MeasureTime frameDescription
Self-efficacy that will be measured using CKD SE before and afterfour weeksThe self-efficacy will be measured using validated tool CKD Self-Efficaccy (CKD SE). The maximum score is 100, and the minimum score is 0

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026