Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-30 @ 10:41 AM
Study NCT ID:
NCT06332469
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-06
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation
Sponsor:
Linkoeping University
Organization:
Study Overview
Official Title:
Feasibility Study of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSERT
Brief Summary:
The goal of this study is to test the feasibility study of an internet based education and support program for patients awaiting kidney transplantation. The study is designed as a national pilot randomized controlled trial with a waitlist control group, to test the feasibility, acceptability, and potential effects of the intervention on patients' physical and mental health.
Detailed Description:
Persons 18 years and older with severe renal failure and accepted on waiting list for kidney transplant with deceased donor in Sweden since at least 6 months will be recruited for participation.
Recruitment will be performed through Sweden's four transplant centers. Exclusion criteria will include not considering themselves able to spend 3-4 hours/week to work in the program. The study will be performed using a study platform which is previously well tested.
The intervention group The intervention is a support an education program, consisting of 9 modules running over 9 weeks. First, an introductory module is given that involves goal setting, followed by two training modules with information; The first on kidney disease, treatment and self-care in severe renal failure and while waiting for kidney transplantation, the second on kidney transplant-specific areas such as drugs, potential complications, lifestyle advice and self-care before and after kidney transplantation. This is followed by three behavioral components spread over five modules/weeks: acceptance (one module), problem solving (one module) and behavioral activation (three modules), and finally a summation module that focuses on consolidating the knowledge learned during the program. Each module consists of texts, illustrations, short films, reminders to practice physical activity and weekly homework for which the people receive feedback from a contact person. Any participants who are transplanted while undergoing the program will be offered to continue the study with adapted modules. Adaptations involve more relevant examples and information regarding drugs, complications and diet which become more relevant after the transplant.
Waitlist control group The control group will be followed with weekly check-ups for 9 weeks via the study platform regarding well-being, whether they have been transplanted or if something happened that affects their life situation. After the intervention period of 9 weeks, the control group will be offered the same program as the intervention group.
Recruitment will be performed through Sweden's four transplant centers. Exclusion criteria will include not considering themselves able to spend 3-4 hours/week to work in the program. The study will be performed using a study platform which is previously well tested.
The intervention group The intervention is a support an education program, consisting of 9 modules running over 9 weeks. First, an introductory module is given that involves goal setting, followed by two training modules with information; The first on kidney disease, treatment and self-care in severe renal failure and while waiting for kidney transplantation, the second on kidney transplant-specific areas such as drugs, potential complications, lifestyle advice and self-care before and after kidney transplantation. This is followed by three behavioral components spread over five modules/weeks: acceptance (one module), problem solving (one module) and behavioral activation (three modules), and finally a summation module that focuses on consolidating the knowledge learned during the program. Each module consists of texts, illustrations, short films, reminders to practice physical activity and weekly homework for which the people receive feedback from a contact person. Any participants who are transplanted while undergoing the program will be offered to continue the study with adapted modules. Adaptations involve more relevant examples and information regarding drugs, complications and diet which become more relevant after the transplant.
Waitlist control group The control group will be followed with weekly check-ups for 9 weeks via the study platform regarding well-being, whether they have been transplanted or if something happened that affects their life situation. After the intervention period of 9 weeks, the control group will be offered the same program as the intervention group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: