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

Cadi Ayyad University

Status: Completed

Conditions: Self-care; Hemodialysis; End Stage Renal Disease

Treatments: Behavioral: Educational intervention for patients undergoing hemodialysis in Morocco

Study type: Interventional

Funder types: Other

Identifiers

NCT06642090

Semlalia-Hemodialysis-2024-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Control Group: Standard Care in Hemodialysis

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Educational intervention for patients undergoing hemodialysis in Morocco