Educational Program for Patients Undergoing Hemodialysis.

NCT06642090 | Completed

• 1 other identifier: Semlalia-Hemodialysis-2024-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the impact of an educational intervention on improving knowledge, self-care practices, and treatment adherence among hemodialysis patients at the Youssoufia Hemodialysis Center, located in the Marrakech-Safi region. Participants will be divided into two groups: an intervention group and a control group. Only the intervention group will receive in-depth training on end-stage renal disease (ESRD), available treatments, potential complications, as well as dietary recommendations and self-care practices tailored for managing arteriovenous fistulas (AVF). The study will assess changes in patients' knowledge, their self-care practices, as well as specific measures such as dry weight, interdialytic weight, and biological markers (calcium, phosphate, and PTH levels).

Conditions

Hemodialysis; Self-care; End Stage Renal Disease

Keywords

Hemodialysis; Arteriovenous fistula self-care; Therapeutic adherence; Patient knowledge; Educational program

Outcome Measures

Primary Outcomes (13)

• Hemodialysis Adherence

  * Assessment Tool: End-Stage Renal Disease Adherence Questionnaire (ESRDAQ) * Score Range: 0-600 * Unit: Numerical scale * Interpretation: Higher scores indicate better adherence to hemodialysis sessions.

  Assessed in both groups before the intervention and after one month of intervention.

• Interdialytic Weight (IDW)

  Assessment Tool: Patients' records Unit: Kilograms (Kg) Measurement Method: Equal to the average of three successive interdialytic weights recorded

  Assessed before the intervention and 2 months after the intervention.

• Assessment of Patient Knowledge

  This measure assesses patients' level of knowledge before and after the intervention. the tool used is the litératie questionnaire (specific to hemodialysis patients) by Shih et al. Score ranges from 0 to 26. a high score indicates high knowledge.

  Assessment before the intervention and after one month, in both groups

• Self-Care of the Arteriovenous Fistula

  This measure will examine patients' self-care practices regarding their arteriovenous fistula (AVF) before and after the intervention. The tool is the "scale assessment of self-care behaviors with arteriovenous fistula in hemodialysis" (ASBHD-AVF), with scores ranging from 16 to 80. A high score indicates high-level fistula self-care.

  Assessment before the intervention and after 1 months in both groups.

• Medication Adherence

  * Assessment Tool: End-Stage Renal Disease Adherence Questionnaire (ESRDAQ) * Score Range: 0-200 * Unit: Numerical scale * Interpretation: Higher scores indicate better adherence to prescribed medications.

  Assessed in both groups before the intervention and after one month of intervention.

• Diet Adherence

  * Assessment Tool: End-Stage Renal Disease Adherence Questionnaire (ESRDAQ) * Score Range: 0-200 * Unit: Numerical scale * Interpretation: Higher scores indicate better adherence to dietary recommendations

  Assessed in both groups before the intervention and after one month of intervention.

• Fluid Restriction Adherence

  * Assessment Tool: End-Stage Renal Disease Adherence Questionnaire (ESRDAQ) * Score Range: 0-200 * Unit: Numerical scale * Interpretation: Higher scores indicate better adherence to water intake restrictions.

  Assessed in both groups before the intervention and after one month of intervention.

• Overall Therapeutic Adherence

  * Assessment Tool: End-Stage Renal Disease Adherence Questionnaire (ESRDAQ). * Score Range: 0-1200 * Unit: Numerical scale * Interpretation: Higher overall scores indicate stronger adherence across all areas.

  Assessed in both groups before the intervention and after one month of intervention

• Dry Weight

  * Assessment Tool: Patients' records * Unit: Kilograms (Kg)

  Assessed before the intervention (last dry weight) and 2 months after the intervention.

• Body Mass Index (BMI)

  * Assessment Tool: Derived from patients' records * Unit: Kilograms per square meter (Kg/m²) * Calculation Method: BMI = Dry Weight (Kg) / Height (m²) using height from patients' records.

  Calculated before the intervention (using last dry weight) and 2 months after the intervention.

• Calcium Level

  * Assessment Tool: Routine biological assessments (from patients' records) * Unit: Millimoles per liter (mmol/L)

  Assessed before the intervention (from the last routine biological assessment) and 2 months after the intervention (from the routine biological assessment taken at least 2 months after the intervention).

• Phosphate Level

  * Assessment Tool: Routine biological assessments (from patients' records) * Unit: Millimoles per liter (mmol/L)

  Assessed before the intervention (from the last routine biological assessment) and 2 months after the intervention (from the routine biological assessment taken at least 2 months after the intervention).

• Parathyroid Hormone (PTH)

  * Assessment Tool: Routine biological assessments (from patients' records) * Unit: Picograms per milliliter (pg/mL)

  Assessed before the intervention (from the last routine biological assessment) and 2 months after the intervention (from the routine biological assessment taken at least 2 months after the intervention).

Secondary Outcomes (2)

• Assessment of Disease Acceptance.

  Assessment before the intervention, in both groups.

• Assessment of Perception of Social Support

  Assenssement just before the educational intervention in both groups

Study Arms (2)

Control Group: Standard Care in Hemodialysis

NO INTERVENTION

This arm of the study includes 34 patients undergoing hemodialysis who will notany intervention. Participants will continue to receive the usual care provided by the hemodialysis center. No educational sessions will be delivered in this group. Clinical outcomes, including health parameters, will be assessed in comparison to those in the intervention group after the study period.

Intervention Group

EXPERIMENTAL

This intervention group includes 36 patients at a public hemodialysis center in the Marrakech-Safi region. this group will engage in an educational program designed to enhance their understanding of chronic kidney disease and promote self-care for venous access. The curriculum covers topics such as disease etiology, symptoms, hemodialysis principles, medication roles, and dietary recommendations. The ultimate objective is to improve treatment adherence and optimize the management of dry weight and interdialytic weight, surpassing the standard care received by the control group.

Behavioral: Educational intervention for patients undergoing hemodialysis in Morocco

Interventions

Educational intervention for patients undergoing hemodialysis in Morocco BEHAVIORAL

This is the first educational intervention in Morocco to improve the knowledge, self-care, and biological characteristics of patients undergoing hemodialysis.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Patients undergoing hemodialysis (HD) for at least 3 months
• Patients aged \> 18 years
• Patients can understand Arabic
• Patients expressing written informed consent to participate in the study

You may not qualify if:

• Patients with impaired consciousness or memory
• Patients with communication impairments (auditory or verbal)
• Patients with psychological impairment

Sponsors & Collaborators

• Cadi Ayyad University: lead

Study Sites (1)

Youssoufia Hemodialysis Center, Youssoufia, Marrakech-Safi Region, Morocco

Youssoufia, Marrakech-Safi, Morocco

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Treatment Adherence and Compliance

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; Health Behavior; Behavior

Study Officials

• Loubna MAZZI, phD Candidate

  Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University

  PRINCIPAL INVESTIGATOR

• Mohamed CHERKAOUI, phD

  Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University

  STUDY CHAIR

• Abdelhafid BENKSIM, phd

  Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University

  STUDY DIRECTOR

Study Design

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

Model Details: This interventional study follows a randomized controlled trial (RCT) design, comparing the effectiveness of an educational intervention against standard care in patients undergoing hemodialysis. Participants will be randomly assigned to one of two groups: the intervention group, which will receive targeted educational sessions focused on chronic kidney disease management. The control group didn't receive any intervention. The educational program aims to enhance patient knowledge, improve self-management skills, and optimize clinical outcomes such as medication adherence and weight management. Assessments will be conducted at baseline and after the intervention to evaluate changes in knowledge, self-care behaviors, and clinical parameters. The study will be conducted in a public hemodialysis center in the Marrakech-Safi region, and aims to provide insights into the impact of educational interventions on patient outcomes in this population

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)