Effect of the HafifMod Programme on Interdialytic Weight Gain in Hemodialysis Patients

NCT05941091 | Unknown

• 1 other identifier: Sal.h7331
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Haemodialysis (HD) is the most commonly used method among renal replacement therapy options in patients with End Stage Renal Failure. Although one of the most important factors affecting the success of this treatment is compliance with fluid restriction, the rates of non-compliance with fluid control vary between 10-74%. It is understood from the literature that fluid restriction is one of the most difficult areas in compliance with HD treatment. Interdialytic weight gain is the most widely accepted method to assess compliance with fluid control by measuring the amount of fluid accumulated in the body. Thus, studies on this subject have shown that excessive interdialytic weight gain is a common problem in HD patients. It is known that excessive interdialytic weight gain increases the risk of morbidity and mortality in HD patients. The main factors causing interdialytic weight gain are fluid and salt intake between two HD sessions is appears to be. Therefore, it is stated that the easiest solution to control excessive interdialytic weight gain is to reduce fluid and salt intake. However, studies have reported that HD patients have difficulty in adapting to a salt-restricted diet, and in this case, they increase their fluid consumption. Therefore, it is of vital importance that public health nurses carry out interventions to ensure HD patients' compliance with fluid and salt control. In the literature review conducted with this perspective, studies were encountered in which results were obtained that m-health interventions provided a decrease in interdialytic weight gain averages and sodium intake. In this direction, a HafifMod programme based on the use of mobile health technologies was created. The aim of the study is to examine the effect of the LightMod programme for fluid and salt control guided by the Health Belief Model on interdialytic weight gain in routine haemodialysis patients.

Conditions

End-Stage Renal Disease; Hemodialysis; Interdialytic Weight Gain

Keywords

Hemodialysis patients; Fluid control; Salt control; Interdialytic weight

Outcome Measures

Primary Outcomes (1)

• Interdialytic Weight Gain

  H1: Decrease in the mean of interdialytic weight gain- The difference between the weight measured at the entrance to the hemodialysis session and the predetermined dry weight of the patient will be recorded as the interdialytic weight gain value. In addition, a single ramp dialysis scale will be used for weight measurement and the measurements will be recorded in kg. The measurement data obtained during the dialysis sessions within the 3-month research period will be recorded in the 'Session Attendance and Weight Tracking Chart (Chart-1)'.

  0-3 months (Repeated tests at 1, 4, 8 and 12 weeks)

Secondary Outcomes (4)

• Fluid Control in Hemodialysis Patients Scale

  0-3 months (Repeated tests at 1 and 12 weeks)

• Serum Sodium Level

  0-3 months (Repeated tests at 1, 4, 8 and 12 weeks)

• Beliefs About Dietary Compliance Scale

  0-3 months (Repeated tests at 1 and 12 weeks)

• Beliefs About Dietary Compliance Scale

  0-3 months (Repeated tests at 1 and 12 weeks)

Study Arms (2)

Intervention Group or HafifMod Group

EXPERIMENTAL

The HafifMod Programme; It consists of modular education practice and a mobile application offered to HD patients.

Behavioral: HafifMod Programme

Control group

ACTIVE COMPARATOR

Prepared by a dietitian; As a result of the distribution of a printed material called "Nutrition Guide for Dialysis Patients" to the active control group, individuals will be informed about nutrition.

Behavioral: Distribution of printed material

Interventions

HafifMod Programme BEHAVIORAL

MODULAR EDUCATION PROGRAMME: A training program consisting of five modules, shaped by the main headings of fluid and salt control in hemodialysis patients, was created. It is aimed that the patients receive training on a topic each week in a gradual manner. It will be ensured that HD patients can watch the modular training videos prepared in the computer environment on a tablet or computer. MOBİLE APPLICATION: Through the mobile application to be developed, the maximum amount of fluid that HD patients should consume per day will be calculated automatically based on their dry weight. In addition, a system will be created where the user can manually enter the amount of fluid consumed daily and add it to the total amount of fluid consumed. In this way, people will be able to learn the amount of fluid they consume daily. In addition, the content of the application will include informative messages in the form of educational short tips and modular training videos.

Intervention Group or HafifMod Group

Distribution of printed material BEHAVIORAL

In the study, a general dietary guideline including fluid and salt restriction, which is a printed educational material for the control group, will be used. Thus, it is planned that the participants in the control group will have a guide resource that will enable them to be informed about nutrition. In this way, an educational practice based on the distribution of printed material will be carried out for the control group. Except for the material distribution practice, the routine care procedures the unit will be maintained in the same way, and no different a practice will be made.

Control group

Eligibility Criteria

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

You may qualify if:

• Those who gained more than 3% of their dry weight in at least one of the interdialytic weight gains covering the four-week period before the start of the study,
• Those who have received routine HD treatment for at least three months,
• Those whose dry weight has been determined,
• Smartphone users,
• Those who do not have severe visual and hearing impairment that would constitute an obstacle to the research,
• Those who are place, time and person oriented,
• Outpatients receiving HD treatment,
• Those with a routine HD program of 3 days and 4 hours a week,
• Those who do not have a psychiatric disorder that would constitute an obstacle to the research.

You may not qualify if:

• Those receiving home hemodialysis treatment,
• Those in the home hemodialysis training process,
• Those with plans to make changes to the dialysis center in the next three months from the start of the study,
• Patients who do not undergo ultrafiltration because their urine volume is sufficient.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Salih Güler

Kepez, Antalya, 07090, Turkey (Türkiye)

Location

Related Publications (1)

• Hong LI, Wang W, Chan EY, Mohamed F, Chen HC. Dietary and fluid restriction perceptions of patients undergoing haemodialysis: an exploratory study. J Clin Nurs. 2017 Nov;26(21-22):3664-3676. doi: 10.1111/jocn.13739. Epub 2017 Mar 22.

  PMID: 28122399 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Nurse

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 12, 2023
• Study Start: October 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: October 15, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)