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Not yet recruitingNCT06306859SIKIDIUpdated Mar 12, 2024

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

An interventional study of Using m-health for monitoring and education provision and Standard care in Quality of Life, Self Efficacy and Chronic Kidney Diseases, sponsored by Universitas Muhammadiyah Yogyakarta. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Universitas Muhammadiyah Yogyakarta · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Quality of life
  • self efficacy
  • chronic kidney disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Universitas Muhammadiyah Yogyakarta is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • emergency hemodialysis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • Active comparator
    Comparator

    The comparator group will be given standard care

    Other: Standard care

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: four weeks

Secondary outcomes

  1. 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

    Time frame: four weeks

07

Study locations

1 site
  • RS PKU Muhammadiyah Bantul
    Bantul, Yogy 55183, Indonesia
    • Indra Prasetyantori, Master · Contact
08

References and documents

Individual participant data

Plan to share: Undecided — The data will be provided upon request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06306859
Lead sponsor
Universitas Muhammadiyah Yogyakarta
Collaborators
Ministry of Education Culture, Research and Technology
Responsible party
Erna Rochmawati (Dr, Universitas Muhammadiyah Yogyakarta) — Principal investigator
First posted
Mar 12, 2024
Start date
Mar 15, 2024 (estimated)
Primary completion
Oct 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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