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HemodialysisEDU-HDNCT06642090

Educational Program for Patients Undergoing Hemodialysis.

A study testing Educational intervention for patients undergoing hemodialysis in Morocco in people with Hemodialysis and Self-care, run by Cadi Ayyad University at 1 site in Morocco.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodialysis, Self-care, End Stage Renal Disease
What is being tested?
Educational intervention for patients undergoing hemodialysis in Morocco
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteMorocco
Study dates
15 Oct 2024to 5 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Morocco1 site
  • Youssoufia Hemodialysis Center, Youssoufia, Marrakech-Safi Region, Morocco

    Youssoufia, Marrakesh-Safi

Other trials in Morocco

About this study

Official title: 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).

Read the 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.

Being tested
Educational intervention for patients undergoing hemodialysis in Morocco
Keywords
Hemodialysis, Arteriovenous fistula self-care, Therapeutic adherence, Patient knowledge, Educational program
Medical subject headings
Kidney Failure, Chronic, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational intervention for patients undergoing hemodialysis in MoroccoBehavioural

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

Study groups in NCT06642090
Study groupRoleWhat they receive
Control Group: Standard Care in HemodialysisNo interventionThis 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 GroupExperimentalThis 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.
Receives: Behavioral: Educational intervention for patients undergoing hemodialysis in Morocco

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Interdialytic Weight (IDW)

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

    Measured: Assessed before the intervention and 2 months after the intervention.

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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

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

  7. 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.

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

  8. 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.

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

  9. Dry Weight

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

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

  10. 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.

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

  11. Calcium Level

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

    Measured: 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).

  12. Phosphate Level

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

    Measured: 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).

  13. Parathyroid Hormone (PTH)

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

    Measured: 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)
  1. 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.

    Measured: Assessment before the intervention, in both groups.

  2. 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

    Measured: Assenssement just before the educational intervention in both groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start15 Oct 2024
  3. Primary completion5 Feb 2025
  4. Study completion5 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06642090
Sponsor's protocol ID
Semlalia-Hemodialysis-2024-001
Acronym
EDU-HD
Status last verified
Feb 2025
First submitted
7 Oct 2024
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Educational intervention for patients undergoing hemodialysis in Morocco in people with Hemodialysis and Self-care, run by Cadi Ayyad University at 1 site in Morocco.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemodialysis Adherence (time frame: Assessed in both groups before the intervention and after one month of intervention.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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