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临床试验/NCT06642090
NCT06642090已完成不适用

Impact of Educational Programs on the Knowledge and Self-care of Patients Undergoing Hemodialysis in Morocco.

Cadi Ayyad University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Parathyroid Hormone (PTH)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients with impaired consciousness or memory
  • Patients with communication impairments (auditory or verbal)
  • Patients with psychological impairment

结局指标

主要结局

Parathyroid Hormone (PTH)

时间窗: 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)

Hemodialysis Adherence

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Assessed before the intervention (last dry weight) and 2 months after the intervention.

* Assessment Tool: Patients' records * Unit: Kilograms (Kg)

Body Mass Index (BMI)

时间窗: 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.

Calcium Level

时间窗: 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

时间窗: 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)

次要结局

  • Assessment of Disease Acceptance.(Assessment before the intervention, in both groups.)
  • Assessment of Perception of Social Support(Assenssement just before the educational intervention in both groups)

研究者

发起方
Cadi Ayyad University
申办方类型
Other
责任方
Principal Investigator
主要研究者

MAZZI Loubna

Principal Investigator

Cadi Ayyad University

研究点 (1)

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