An interventional study of Educational intervention for patients undergoing hemodialysis in Morocco in Hemodialysis, Self-care and End Stage Renal Disease, sponsored by Cadi Ayyad University. Completed at 1 site in Morocco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Cadi Ayyad University · Not applicable, Interventional, and Prevention
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).
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 70 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Cadi Ayyad University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Assessed in both groups before the intervention and after one month of intervention
Dry Weight
* Assessment Tool: Patients' records * Unit: Kilograms (Kg)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
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.
Time frame: 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
Time frame: Assenssement just before the educational intervention in both groups
Plan to share: No — 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.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Cadi Ayyad University