Clinical trial NCT06332469: Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation
Official title: Feasibility Study of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: kidney transplantation
psychosocial support
patient education
e-health
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2024-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group gets immediate access to the 9 week program, and the waitlist control group gets access after a 9 week waiting period.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* severe renal failure and accepted on waiting list for kidney transplant with deceased donor in Sweden since at least 6 months

Exclusion Criteria:

* Not considering themselves able to spend 3-4 hours/week to work in the program
* Another illness that permanently renders kidney transplantation impossible

Primary outcomes:
measure: Kidney transplant understanding tool (K-TUT)
timeFrame: 9 weeks
measure: Self-care in chronic illness inventory v.4c
timeFrame: 9 weeks
measure: The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G
timeFrame: 9 weeks
measure: Pearlin Mastery Scale
timeFrame: 9 weeks
measure: The Depression Anxiety Stress Scales 21 (DASS-21)
timeFrame: the last week
measure: Acceptance of chronic health conditions scale (ACHC)
timeFrame: 9 weeks
measure: EQ-5D-5L
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Linköping University,
city: Norrköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Linkoeping University
name: Kristina Nilsson, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson K, Westas M, Andersson G, Johansson P, Lundgren J. Waiting for kidney transplantation from deceased donors: Experiences and support needs during the waiting time -A qualitative study. Patient Educ Couns. 2022 Jul;105(7):2422-2428. doi: 10.1016/j.pec.2022.02.016. Epub 2022 Feb 22.
citation: Nilsson K, Andersson G, Johansson P, Lundgren J. Developing and designing an internet-based support and education program for patients awaiting kidney transplantation with deceased donors through: a Delphi study. BMC Nephrol. 2023 Oct 25;24(1):311. doi: 10.1186/s12882-023-03364-2.