Clinical trial NCT06642090: Educational Program for Patients Undergoing Hemodialysis.
Official title: Impact of Educational Programs on the Knowledge and Self-care of Patients Undergoing Hemodialysis in Morocco.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Self-care
End Stage Renal Disease
Keywords: Hemodialysis
Arteriovenous fistula self-care
Therapeutic adherence
Patient knowledge
Educational program
Lead sponsor: Cadi Ayyad University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief 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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Hemodialysis Adherence
timeFrame: Assessed in both groups before the intervention and after one month of intervention.
measure: Interdialytic Weight (IDW)
timeFrame: Assessed before the intervention and 2 months after the intervention.
measure: Assessment of Patient Knowledge
timeFrame: Assessment before the intervention and after one month, in both groups
measure: Self-Care of the Arteriovenous Fistula
timeFrame: Assessment before the intervention and after 1 months in both groups.
measure: Medication Adherence
timeFrame: Assessed in both groups before the intervention and after one month of intervention.
measure: Diet Adherence
timeFrame: Assessed in both groups before the intervention and after one month of intervention.
measure: Fluid Restriction Adherence
timeFrame: Assessed in both groups before the intervention and after one month of intervention.
measure: Overall Therapeutic Adherence
timeFrame: Assessed in both groups before the intervention and after one month of intervention
measure: Dry Weight
timeFrame: Assessed before the intervention (last dry weight) and 2 months after the intervention.
measure: Body Mass Index (BMI)
timeFrame: Calculated before the intervention (using last dry weight) and 2 months after the intervention.
measure: Calcium Level
timeFrame: 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).
measure: Phosphate Level
timeFrame: 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).
measure: Parathyroid Hormone (PTH)
timeFrame: 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:
measure: Assessment of Disease Acceptance.
timeFrame: Assessment before the intervention, in both groups.
measure: Assessment of Perception of Social Support
timeFrame: Assenssement just before the educational intervention in both groups
Other outcomes:
Locations:
city: Youssoufia
country: Morocco
facility: Youssoufia Hemodialysis Center, Youssoufia, Marrakech-Safi Region, Morocco
state: Marrakech-Safi
Study officials:
affiliation: Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University
name: Loubna MAZZI, phD Candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University
name: Mohamed CHERKAOUI, phD
role: STUDY_CHAIR
affiliation: Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University
name: Abdelhafid BENKSIM, phd
role: STUDY_DIRECTOR
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