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

NCT06306859 | Not Yet Recruiting

• 1 other identifier: SIKIDI 2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Quality of life; self efficacy; chronic kidney disease

Outcome Measures

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

  four weeks

Secondary Outcomes (1)

• Self-efficacy that will be measured using CKD SE before and after

  four weeks

Study Arms (2)

SIKIDI group

EXPERIMENTAL

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

Comparator

ACTIVE COMPARATOR

The comparator group will be given standard care

Other: Standard care

Interventions

Using m-health for monitoring and education provision BEHAVIORAL

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

SIKIDI group

Standard care OTHER

The comparator group will be given standard and routine care

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• emergency hemodialysis

Sponsors & Collaborators

• Universitas Muhammadiyah Yogyakarta: lead
• Ministry of Education Culture, Research and Technology: collaborator

Study Sites (1)

RS PKU Muhammadiyah Bantul

Bantul, Yogy, 55183, Indonesia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The sample will be divided based on the schedule of hemodialysis. Intervention group will be chosen from Monday-Thursday.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

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

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

ID (1)