Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation

NCT ID: NCT06332469

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-18

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment group

This group gets immediate access to the program

Group Type EXPERIMENTAL

Internet based education and support program for patients awaiting kidney transplantation

Intervention Type BEHAVIORAL

A guided internet based 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 educational modules with information regarding kidney disease, treatment and self-care in severe renal failure and while waiting for kidney transplantation, and kidney transplant-specific areas. Supportive content consist of three behavioral components spread over five modules/weeks and are based on cognitive behavioural therapy principles. The last module is a summation focusing 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 participants receive feedback from a contact person.

Wailtlist group

This group gets access to the same program after a 9 week waiting time

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet based education and support program for patients awaiting kidney transplantation

A guided internet based 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 educational modules with information regarding kidney disease, treatment and self-care in severe renal failure and while waiting for kidney transplantation, and kidney transplant-specific areas. Supportive content consist of three behavioral components spread over five modules/weeks and are based on cognitive behavioural therapy principles. The last module is a summation focusing 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 participants receive feedback from a contact person.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kristina Nilsson

MSc, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristina Nilsson, MSc

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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Linköping University,

Norrköping, , Sweden

Site Status

Linköping University

Norrköping, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 35272905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37880582 (View on PubMed)

Related Links

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http://www.iterapi.se/sites/insert/

The study web platform where study information is available and potential participants can register their interest of participation.

Other Identifiers

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INSERT feasibility

Identifier Type: -

Identifier Source: org_study_id

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