Educational Program for Patients Undergoing Hemodialysis. (EDU-HD)

Impact of Educational Programs on the Knowledge and Self-care of Patients Undergoing Hemodialysis in Morocco.

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).

Study Overview

• Status: Completed
• Conditions: Hemodialysis; End Stage Renal Disease; Self-care
• Intervention / Treatment: Behavioral: Educational intervention for patients undergoing hemodialysis in Morocco

Detailed Description

This study is a randomized controlled trial aimed at evaluating 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.

Methodology: Participants will be recruited from adult patients on hemodialysis for more than three months. They will be randomized into two groups: an intervention group, which will receive educational training, and a control group, which will receive usual care without educational intervention. Sociodemographic and clinical criteria will be collected through the examination of patient medical records.

Intervention: The educational program will consist of six sessions led by a pedagogy expert, in collaboration with a nephrologist a dietitian and hemodialysis nurses. The sessions will cover topics such as end-stage renal disease (ESRD), available treatments, potential complications, as well as dietary recommendations and self-care practices for managing arteriovenous fistulas (AVF).

Evaluations: Outcomes will be measured using validated questionnaires to assess knowledge, self-care practices, and treatment adherence. Biological measures (calcium, phosphate, and PTH levels, dry weight and interdialytic weight) will be taken before the intervention and two months after, in accordance with the center's usual assessments.

The questionnaires will be administered before the intervention and one month after the training to measure changes in patients' knowledge and practices.

Ethical Considerations: The study will adhere to all ethical considerations, including obtaining informed consent and the right for participants to withdraw at any time. The program has already received approval from the ethics committee, and it will also be approved by a nephrologist and a dietitian prior to implementation.

Data Analysis: Data will be analyzed using SPSS. Paired t-tests and independent t-tests will be used to compare results between groups. For non-normally distributed variables, non-parametric tests will be applied. Additionally, linear regression analysis will be conducted to examine associations between variables.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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

Exclusion criteria :

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group: Standard Care in Hemodialysis; 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.
Experimental: Intervention Group; 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; This is the first educational intervention in Morocco to improve the knowledge, self-care, and biological characteristics of patients undergoing hemodialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Disease Acceptance.	- Assessment of disease acceptance: just before educational intervention. The score ranges from 8 to 40 points; a score of 8 indicates extremely low acceptance of the disease, and 40 indicates extremely high acceptance.	Assessment before the intervention, in both groups.
Assessment of Perception of Social Support	Assessment of perceived social support: just before the intervention, using the Multidimensional Scale of Perceived Social Support, scores range from 12 to 84. Higher scores express stronger feelings of being socially supported	Assenssement just before the educational intervention in both groups

Collaborators and Investigators

• Sponsor: Cadi Ayyad University
• Investigators: Principal Investigator: Loubna MAZZI, phD Candidate, Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University; Study Chair: Mohamed CHERKAOUI, phD, Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University; Study Director: Abdelhafid BENKSIM, phd, Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Hemodialysis; Therapeutic adherence; Educational program; Patient knowledge; Arteriovenous fistula self-care
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: Semlalia-Hemodialysis-2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data (IPD) will not be shared for several reasons. First and foremost, protecting the confidentiality of participants is a priority. Given the sensitive nature of the data collected, it is essential to ensure that the identity and personal information of participants remain protected.

Secondly, the logistical requirements associated with preparing the data for sharing can be complex and may require resources that we are unable to mobilize at this time. Finally, we aim to maintain the integrity of the data by limiting access to researchers with the necessary expertise and qualifications to analyze it.

We are committed to adhering to ethical and regulatory standards for data protection throughout the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No