NCT07277530

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 20, 2025

Last Update Submit

November 29, 2025

Conditions

Keywords

HemodialysisNurse-LedNutritional EducationHyperkalemia ManagementInterdialytic Weight GainQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Change in Serum Potassium Level

    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 Outcomes (2)

  • Change in Interdialytic Weight Gain (IDWG)

    4 weeks before baseline and 4 weeks at the end of the 12-week intervention

  • Change in Quality of Life (QoL) Index Score

    From baseline to 12 weeks after the start of the intervention.

Study Arms (1)

Nutritional Education Intervention

EXPERIMENTAL

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.

Behavioral: Nutritional Education Intervention

Interventions

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.

Nutritional Education Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis. Participants must have provided written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Settat Hemodialysis Center,el borouj Hemodialysis Center, Al amal Hemodialysis Center

Settat, Settat, 26000, Morocco

Location

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a pre-post experimental investigation. All participants were assigned to the single intervention group and acted as their own controls, with outcomes measured before (T0) and after (T1) the nurse-led nutritional education program. There was no separate control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 11, 2025

Study Start

February 1, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie the results reported in this article (e.g., serum potassium levels, IDWG, and EQ-5D-5L scores) will be shared. Data will be made available upon request to the Principal Investigator (PI), following the publication of the final article. The data will be de-identified to protect participant privacy. Requests should be justified and may require an institutional agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The IPD will be available starting six months after publication of the final article and will remain available for a period of five years (until 2030).
Access Criteria
The identified individual participant data (IPD) and supporting documentation will be accessible to qualified researchers who submit a methodologically sound and ethically approved proposal to the Principal Investigator (PI). Access will be granted via a secure shared drive after signing a data access agreement.
More information

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