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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: Standard Care in Hemodialysis | No Intervention | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodialysis Adherence |
| Assessed in both groups before the intervention and after one month of intervention. |
| Interdialytic Weight (IDW) | Assessment Tool: Patients' records Unit: Kilograms (Kg) Measurement Method: Equal to the average of three successive interdialytic weights recorded | Assessed before the intervention and 2 months after the intervention. |
| 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. | Assessment before the intervention and after one month, in both groups |
| 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. | Assessment before the intervention and after 1 months in both groups. |
| Medication Adherence |
| Assessed in both groups before the intervention and after one month of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessment before the intervention, in both groups. |
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Inclusion criteria:
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Loubna MAZZI, phD Candidate | Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University | Principal Investigator |
| Mohamed CHERKAOUI, phD | Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University | Study Chair |
| Abdelhafid BENKSIM, phd | Laboratory of Pharmacology, Neurobiology, Anthropobiology and Environment, Faculty of Sciences Semlalia, Cadi Ayyad University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Youssoufia Hemodialysis Center, Youssoufia, Marrakech-Safi Region, Morocco | Youssoufia | Marrakesh-Safi | Morocco |
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.
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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
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| Diet Adherence |
| Assessed in both groups before the intervention and after one month of intervention. |
| Fluid Restriction Adherence |
| Assessed in both groups before the intervention and after one month of intervention. |
| Overall Therapeutic Adherence |
| Assessed in both groups before the intervention and after one month of intervention |
| Dry Weight |
| Assessed before the intervention (last dry weight) and 2 months after the intervention. |
| Body Mass Index (BMI) |
| Calculated before the intervention (using last dry weight) and 2 months after the intervention. |
| 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). |
| 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). |
| 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 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 |
| Assenssement just before the educational intervention in both groups |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |