The Effect of Structured Education and Decision Support on Patient Outcomes for Patients Starting Dialysis Treatment in Emergency Conditions

NCT06842069 | Completed

• 1 other identifier: 2016.255.IRB3.166
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: This study aimed to develop a decision supported education program and evaluate the effect on the following dialysis patient outcomes: treatment satisfaction, treatment adherence, self-care, quality of life, depression, patient laboratory results, and clinical results. Design: This study used a randomized controlled design. Method: Dialysis Education and Decision Tree Support application developed. Patients who started renal replacement treatment in urgent condition were placed into a Dialysis Education Program group (n=43) and Decision Tree Supported Education Program group (n=43) using the simple random sampling method. Training was provided to both groups using curriculum and training tools during two interviews. The decision tree application was used during an additional third interview with the patients in the "Decision Tree Supported Education Program" group. Data collected using the "Demographical and Clinical Data" form, the "Patient Assessment of Chronic Illness Care-Patient" Scale, the "Self-Care Ability of Chronic Dialysis Patients Assessment Scale," the "General Quality of Life Scale," and the "Patient Health Survey."

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (6)

• Clinical and biochemical outcomes

  Clinical and biochemical outcomes include measurements of hemoglobin, hematocrit, albumin, total protein, C-reactive protein (CRP), calcium, phosphorus, parathormone, blood urea nitrogen (BUN), creatinine, blood pressure, residual urine volume, and Kt/V

  Before intervention and one month after intervention

• Treatment adherence

  Treatment adherence was measured using the End Stage Renal Disease Adherence Questionnaire (ESRD-AQ), which consisted of four subgroups (adherence to total dialysis sessions, medications, fluid restrictions, and dietary recommendations), with higher scores indicating increased adherence

  Before intervention and one month after intervention

• Patient Assessment of Chronic Illness Care Scale-Patient Form

  Patient Assessment of Chronic Illness Care Scale-Patient Form (Turkish PACIC): Consists of five sub-dimensions: patient participation, decision-making, goal setting/guidance, problem solving, and monitoring/coordination. Higher scale score indicates that individuals with chronic disease are satisfied with the care they receive and that chronic disease management is adequate

  Before intervention and one month after intervention

• Self-Care Ability

  It is a data collection tool that used to asses ability of participant about medication, diet, hygenic care and mental state. Higher scores indicate better self-care ability of patiens

  Before intervention and one month after intervention

• Quality of Life Measurement

  The EQ-5D is a general health scale used to measure quality of life. The scale consists of two parts. Part A., the EQ-5D index scale, consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Part B. the EQ-5D VAS scale, is a visual analog scale in which individuals give values between 0 and 100

  Before intervention and one month after intervention

• Psychological assessment

  Aims to make a psychological assessment of patients in the last two weeks of dialysis, measuring the extent to which such problems disturb patients

  Before intervention and one month after intervention

Study Arms (2)

Dialysis Education Program (DEP)

ACTIVE COMPARATOR

Patients beginning urgent renal replacement treatment were placed into a Dialysis Education Program group (n=43) All patients in the DEP group were trained on the subjects included in the Dialysis Education Programme with two consequtive interview. Interview 1: In this 30-minute session, the aim of the training program was explained with an overview of CKD, sparing time for potential patient questions. The second training day was scheduled according to patients' agenda and their next hemodialysis session. Interview 2: RRT options were explained in the 30-minute training session, followed by interactive discussion with patients, ensuring that patients understood the information. When the training was completed, a guidebook ("Treatment Options in Kidney Failure-Conscious Start") was distributed to participants

Behavioral: Dialysis Education for Urgent Dialysis Start Patient

Decision Tree Supported Education Program group (n=43)

EXPERIMENTAL

Patients beginning urgent renal replacement treatment were placed into a Decision Tree Supported Education Program group (n=43) All patients were trained on the subjects included in the Dialysis Education Programme with three consequtive interview. Interview 1: In this 30-minute session, the aim of the training program was explained with an overview of CKD, sparing time for potential patient questions. The second training day was scheduled according to patients' agenda and their next hemodialysis session. Interview 2: RRT options were explained in the 30-minute training session, followed by interactive discussion with patients, ensuring that patients understood the information. When the training was completed, a guidebook ("Treatment Options in Kidney Failure-Conscious Start") was distributed to participants Interview 3: Developed DecisionTree application ("My Life, My Choice") was performed . RRT options were assessed interactively during further discussions (30 minutes)

Behavioral: Decision Aid Supported Education

Interventions

Decision Aid Supported Education BEHAVIORAL

Dialysis Education

Decision Tree Supported Education Program group (n=43)

Dialysis Education for Urgent Dialysis Start Patient BEHAVIORAL

Education provided in two consequtive educational session. During first 30-minute session, the aim of the training program was explained with an overview of CKD, sparing time for potential patient questions. The second training day was scheduled according to patients' agenda and their next hemodialysis session. Second Interview: RRT options were explained in the 30-minute , followed by interactive discussion with patients, ensuring that patients understood the information. When the training was completed, a guidebook ("Treatment Options in Kidney Failure-Conscious Choice, Conscious Start") was distributed to participants. The third interview date and time was scheduled with the patients in the DTSEP group.

Dialysis Education Program (DEP)

Eligibility Criteria

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

You may qualify if:

• diagnosed with an emergent indication for dialysis treatment, displayed ESRD symptoms or signs and a glomerular filtration rate (GFR) of 5-10 mL/min/1.73 m2) completed at least three hemodialysis sessions, had no problems with communication, and consented to participate in the study.

You may not qualify if:

• Illiterate patients and Those who had previously undergone RRT were excluded from the study

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Bekker HL, Winterbottom AE, Gavaruzzi T, Finderup J, Mooney A. Decision aids to assist patients and professionals in choosing the right treatment for kidney failure. Clin Kidney J. 2023 Sep 13;16(Suppl 1):i20-i38. doi: 10.1093/ckj/sfad172. eCollection 2023 Sep.

  PMID: 37711634 BACKGROUND

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AssistantProfessor

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: February 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: November 30, 2018
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)