NCT06546852

Brief Summary

The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

July 29, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

education

Outcome Measures

Primary Outcomes (1)

  • Complying with fluid restriction

    Thanks to the training given, patients consume less fluid. posttests were performed usingthe fluid control scale on Hemdodialysis patients. The lowest score from the scale is 24 and the highest score is 72. from scale As the score increases, patients' compliance with fluid control also increases.

    14 weeks,

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will be informed about the purpose and method of the research and will be informed in writing. Informed consent was obtained. Patient Tracking Form, which is a data collection tool, The researcher filled out the Fluid Restriction Scale in Hemodialysis Patients through face-to-face interviews with the patients. The results of the biochemical parameters requested by the physician were recorded. Later Patients will be given a 15-20 minute individual session on fluid restriction in chronic renal failure. A training and education booklet was provided. At the end of the training, the Fluid Restriction Scale in Hemodialysis Patients was applied to the experimental group as a posttest.

Behavioral: education

Control group

NO INTERVENTION

As for the control group, Information was given about the purpose and method of the research, and a written Informed consent was obtained. Data collection tools: Patient Follow-up Form, Hemodialysis patients fluid restriction scale The researcher completed it during face-to-face interviews with the patients. At the end of the follow-up period, the hemodialysis patients completed the fluid restriction scale as a final test.

Interventions

educationBEHAVIORAL

Patient education will be provide

Also known as: Patient education will be provide
Experimental group

Eligibility Criteria

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

You may qualify if:

  • Above 18 years old
  • volunteering
  • good communication
  • chronic kidney failure
  • no amputation
  • hemodialysis 3 days a week

You may not qualify if:

  • Heart battery
  • dialysis 2 days a week
  • more than 200ml of urine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ülkü Yılmaz

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • ülkü yılmaz

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd internal diseases nurse

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 9, 2024

Study Start

January 1, 2023

Primary Completion

April 28, 2023

Study Completion

April 28, 2023

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations