End Stage Renal Disease, Hemodialysis, Self-care
Conditions
Keywords
Hemodialysis, Arteriovenous fistula self-care, Therapeutic adherence, Patient knowledge, Educational program
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.
Interventions
BEHAVIORALEducational 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.
Sponsors
Cadi Ayyad University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parathyroid Hormone (PTH) | 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) |
| Calcium Level | 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) |
| Phosphate Level | 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) |
| Hemodialysis Adherence | 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. |
| Interdialytic Weight (IDW) | 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 |
| Assessment of Patient Knowledge | 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. |
| Self-Care of the Arteriovenous Fistula | 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. |
| Medication Adherence | 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. |
| Diet Adherence | 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 |
| Fluid Restriction Adherence | 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. |
| Overall Therapeutic Adherence | 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. |
| Dry Weight | Assessed before the intervention (last dry weight) and 2 months after the intervention. | * Assessment Tool: Patients' records * Unit: Kilograms (Kg) |
| Body Mass Index (BMI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Perception of Social Support | 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 |
| Assessment of Disease Acceptance. | 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. |
Countries
Morocco
Outcome results
None listed