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Completed

NCT Number: NCT06642090

Educational Program for Patients Undergoing Hemodialysis.

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).

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Key information

Conditions

Hemodialysis Behavior Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Self-care Treatment Adherence and Compliance Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Youssoufia, Marrakesh-Safi, Morocco

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Hemodialysis Adherence

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

    • 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.

  2. Interdialytic Weight (IDW)

    Time frame: Assessed before the intervention and 2 months after the intervention.

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

  3. Assessment of Patient Knowledge

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

    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.

  4. Self-Care of the Arteriovenous Fistula

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

    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.

  5. Medication Adherence

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

    • 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.

  6. Diet Adherence

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

    • 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

  7. Fluid Restriction Adherence

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

    • 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.

  8. Overall Therapeutic Adherence

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

    • 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.

  9. Dry Weight

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

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

  10. Body Mass Index (BMI)

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

    • 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.

  11. Calcium Level

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

  12. Phosphate Level

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

  13. Parathyroid Hormone (PTH)

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

Secondary outcomes

  1. Assessment of Disease Acceptance.

    Time frame: Assessment before the intervention, in both groups.

    • 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.

  2. Assessment of Perception of Social Support

    Time frame: Assenssement just before the educational intervention in both groups

    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

Sponsors and collaborators

Lead sponsor

Cadi Ayyad University

Other

Registry information

Official study title

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

Acronym: EDU-HD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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