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Clinical Trials/NCT06842069
NCT06842069CompletedNot Applicable

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

Atlas University1 site in 1 country86 target enrollmentStarted: February 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
86
Locations
1
Primary Endpoint
Clinical and biochemical outcomes

Study Overview

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."

Detailed Description

Hypotheses of the study H1) A structured DTSEP improves clinical and biochemical outcomes in dialysis patients.

H2) A structured DTSEP improves treatment adherence in dialysis patients. H3) A structured DTSEP improves satisfaction in dialysis patients. H4) A structured DTSEP improves disease management in dialysis patients. H5) A structured DTSEP increases self-care competence in dialysis patients. H6) A structured DTSEP has a positive effect on patients' quality of life. H7) A structured DTSEP reduces the incidence of depression in dialysis patients.

METHOD Design and setting This experimental study used a randomized controlled design.

Participants and data collection The universe of this study consisted of patients started dialysis treatment under emergency conditions in public and private hospitals within the last one year. After predicting an effect size of 0.80 (alpha 0.05), 86 patients were included in the study. Patients were divided into a "Dialysis Education Program" (DEP) only group (n=43) and a "Decision Tree-Support Education Program" (DTSEP) group (n=43) using simple sequential sampling method. A homogenity test was performed to ensure that the patients in both groups were similar.

Inclusion criteria: Inclusion criteria required that patients: were >18 years of age, had been 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) (Nesrallah et al., 2014), had completed at least three hemodialysis sessions, had no problems with communication, and consented to participate in the study. Illiterate patients and those who had previously undergone RRT were excluded from the study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Arms & Interventions

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

Intervention: Dialysis Education for Urgent Dialysis Start Patient (Behavioral)

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)

Intervention: Decision Aid Supported Education (Behavioral)

Outcomes

Primary Outcomes

Clinical and biochemical outcomes

Time Frame: Before intervention and one month after intervention

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

Treatment adherence

Time Frame: Before intervention and one month after intervention

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

Patient Assessment of Chronic Illness Care Scale-Patient Form

Time Frame: Before intervention and one month after intervention

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

Self-Care Ability

Time Frame: Before intervention and one month after intervention

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

Quality of Life Measurement

Time Frame: Before intervention and one month after intervention

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

Psychological assessment

Time Frame: Before intervention and one month after intervention

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Atlas University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zehra Aydin

AssistantProfessor

Atlas University

Study Sites (1)

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