NCT05322291

Brief Summary

The aim of this study is to determine the effect of mobile-based education and counseling developed for hemodialysis patients on the symptoms experienced and the adaptation to the disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

January 31, 2022

Last Update Submit

December 8, 2022

Conditions

Keywords

hemodialysisTreatment Compliancesymptom managemenmobile applicationchronic kidney failure

Outcome Measures

Primary Outcomes (2)

  • Measure

    The effect of mobile-based application and counseling on symptom management will be measured in patients receiving hemodialysis treatment. Patient Information Form and Dialysis Symptom Index will be used for measurement. The dialysis symptom scale includes 30 symptoms that describe physical or emotional symptoms. The patient responds to the symptoms he has experienced in the last week as yes-no, no, he/she answers that he/she has not experienced the symptom, and if yes, he/she has the symptom. If your answer is yes, the extent to which this symptom affects the patient is evaluated with a five-point Likert type scale. It is evaluated and scored as 1=none, 5=very much. After the obtained scores are summed, the total scale score is obtained. The scale point ranges from 0-150. The fact that the total score approaches 150 indicates that the effect of the symptom has increased.

    0-3 months

  • Dialysis symptom

    Reducing dialysis symptoms.

    0-3 months

Secondary Outcomes (2)

  • Measure

    3-6 months

  • End Stage Renal Failure Compliance

    3-6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

The developed mobile application will be installed on the phones of hemodialysis patients in the experimental group. Online consultancy and training will be provided with the application.

Behavioral: Mobil Application

Control Group

NO INTERVENTION

No intervention will be made. They will continue to receive routine care.

Interventions

The mobile application developed will be installed on the phones of hemodialysis patients

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic kidney failure patient
  • Agreeing to be a voluntary participant,
  • Receiving dialysis treatment for at least 3 months,
  • years and over,
  • Able to understand and speak Turkish
  • At least primary school graduate,
  • Using a smart phone for at least one year,
  • Having internet access at home or at work.
  • Able to use internet

You may not qualify if:

  • Speech, hearing and visual impairment,
  • Having any psychiatric diagnosis or treatment that may interfere with perception (Alzheimer, schizophrenia, major depression)
  • rheumatological diseases, fracture, joint health problem, amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Binali Yıldırım University

Erzincan, Merkez, 24800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, ChronicPatient Compliance

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The mobile application developed will be installed on the phones of hemodialysis patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

January 31, 2022

First Posted

April 11, 2022

Study Start

March 28, 2022

Primary Completion

May 23, 2022

Study Completion

July 25, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations