- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277530
Nurse-Led Nutritional Education for Moroccan Dialysis Patients
A Nurse-Led Nutritional Education Intervention Reduces Serum Potassium in Moroccan Hemodialysis Patients Lacking Dietitian Support.
Why was this study done? Many dialysis centers in Morocco lack dietitians to provide proper, individualized dietary support to patients. High potassium levels (hyperkalemia) are a major risk factor for heart problems in dialysis patients. This study tested whether a simple nutritional education program, led by a nurse, could help patients better manage their diet and safely reduce their serum potassium levels.
Who participated? Thirty (30) adult patients with end-stage renal disease receiving hemodialysis participated in the study. They were recruited from three public hemodialysis centers in Morocco that did not have permanent dietitians.
What did participants do? The study was conducted from February to June 2025. Participants received an educational intervention led by a nurse. The sessions covered potassium content in food, fluid intake, thirst management, and physical activity.
What did the study find (Results)? The educational program resulted in a statistically significant reduction in patients' serum potassium levels. The percentage of patients within the ideal potassium range (4 to 5 mmol/L) increased from 36.7% at the start to 46.7% at the end. This demonstrates that a nurse-led program is a practical and beneficial approach to help lower cardiovascular risk in resource-scarce settings.
The study found no significant changes in Quality of Life (QoL) or interdialytic weight gain (IDWG).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-group, pre-post interventional study designed to evaluate the impact of a nurse-led nutritional education program on the management of End-Stage Renal Disease (ESRD) patients undergoing hemodialysis in a resource-limited setting in Morocco. The study enrolled 30 adult patients.
The intervention was conducted over five months (February to June 2025). The program was delivered by a nurse and included face-to-face sessions as well as remote support (WhatsApp). The educational content focused on three main areas:
Dietary management to reduce hyperkalemia (potassium content in food). Fluid restriction and thirst management. Salt restriction and low-impact physical activity. The primary outcome measure was the change in serum potassium levels (Kalemia) from baseline (T0) to post-intervention (T1). Secondary outcomes included changes in interdialytic weight gain (IDWG) and Quality of Life (QoL).
The results demonstrated a statistically significant reduction in patients' serum potassium levels, supporting the practical benefits of the nurse-led program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Settat
-
Settat, Settat, Morocco, 26000
- Settat Hemodialysis Center,el borouj Hemodialysis Center, Al amal Hemodialysis Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. Participants must have provided written informed consent.
Exclusion Criteria:
- Patients who declined to participate; patients who were minors (under 18 years old); and patients with conditions impairing their ability to understand or receive educational content, such as severe hearing loss or cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutritional Education Intervention
This arm represents the single group in this pre-post study.
All 30 participants received the educational intervention over five months (Feb-June 2025).
The program focused on dietary management of potassium and fluid, salt intake, and physical stretching exercises, delivered by a nurse in the Moroccan dialect.
|
Educational sessions focused on dietary management of potassium and fluid restriction, salt intake, and low-impact physical activity (stretching).
The program was delivered by a nurse in the Moroccan dialect via face-to-face and remote (WhatsApp) communication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Serum Potassium Level
Time Frame: From baseline to 12 weeks after the start of the intervention.
|
Change in serum potassium concentration measured at baseline (T0) and after the 12-week educational intervention (T1).
|
From baseline to 12 weeks after the start of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Interdialytic Weight Gain (IDWG)
Time Frame: 4 weeks before baseline and 4 weeks at the end of the 12-week intervention
|
Change in interdialytic weight gain, calculated as the mean IDWG during the 4 weeks before baseline and the 4 weeks at the end of the 12-week educational intervention
|
4 weeks before baseline and 4 weeks at the end of the 12-week intervention
|
|
Change in Quality of Life (QoL) Index Score
Time Frame: From baseline to 12 weeks after the start of the intervention.
|
Measured using the validated Arabic version of the EuroQol 5 Dimensions (EQ-5D-5L) instrument.
|
From baseline to 12 weeks after the start of the intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERS/UEMF-2025/EC10/02 (Other Identifier: Euro-Mediterranean University of Fez Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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