Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642090
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Educational Program for Patients Undergoing Hemodialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Educational Programs on the Knowledge and Self-care of Patients Undergoing Hemodialysis in Morocco
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EDU-HD
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
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 centers 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
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 centers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None