Chronic Kidney DiseasesINSERTNCT06332469
Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation
A study testing Internet based education and support program for patients awaiting kidney transplantation in people with Chronic Kidney Diseases, run by Linkoeping University at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Internet based education and support program for patients awaiting kidney transplantation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSweden
- Study dates
- 18 Apr 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not considering themselves able to spend 3-4 hours/week to work in the program
- Another illness that permanently renders kidney transplantation impossible
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Feasibility Study of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Internet based education and support program for patients awaiting kidney transplantation
- Keywords
- kidney transplantation, psychosocial support, patient education, e-health
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based education and support program for patients awaiting kidney transplantationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | This group gets immediate access to the program Receives: Behavioral: Internet based education and support program for patients awaiting kidney transplantation |
| Wailtlist group | No intervention | This group gets access to the same program after a 9 week waiting time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney transplant understanding tool (K-TUT)
The Kidney Transplant Understanding Tool (K-TUT) is an instrument to assess patient knowledge about kidney transplantation, consisting of 9 true and false, and 13 multiple-choice questions (each with more than 1 potential answer). In total, 69 items address several aspects related to kidney transplantation. Each statement is dichotomized ("correct" or "incorrect"). One point is given for each correct answer chosen, and the scores are summed and converted to percentages. A perfect score (100%) equates to a total of 69 points.
Measured: 9 weeks
Self-care in chronic illness inventory v.4c
A self-report instrument with four scales; the self-care maintenance scale has 7 items, the self-care monitoring scale has 5 items, the self-care management scale has 6 items, and lastly the self-care confidence scale has 10 items. The latter was added after studies showed that self-efficacy is a major predictor of self-care. Each SC-CII item is measured using a 5-point likert scale ranging from "Never" (1) to "Always" (5), "Not likely" (1) to "Very likely" (5) and "Not confident" (1) to "Very confident" (5). The scales use a standardized score from 0 to 100, with higher scores indicating better self-care.
Measured: 9 weeks
The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G
The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G) is a tool designed to assess an individual's confidence in their ability to manage the various aspects of living with a chronic illness. It is a short form of the original Self-Efficacy for Managing Chronic Disease 8-item Scale (SES8G). The scoring involves participants rating their confidence on a numerical scale (e.g., from 1 to 10) for each item. The scores are summed to obtain a total score. Higher scores indicate greater self-efficacy in managing chronic disease, reflecting a higher level of confidence in one's ability to handle the challenges associated with the condition.
Measured: 9 weeks
Pearlin Mastery Scale
The Pearlin Mastery Scale is a self-report instrument designed to measure the extent to which individuals perceive control over their lives and events that affect them. It assesses the concept of "psychological mastery," which refers to an individual's perceived ability to control and influence outcomes in their life.
The Pearlin Mastery Scale consists of 7 items where respondents are asked to rate their level of agreement or disagreement with each statement, reflecting their perceived mastery or control. The scale is scored by summing the responses to the individual items, providing an overall score that indicates the level of perceived mastery. Higher scores suggest a greater sense of mastery or perceived control, while lower scores may indicate a lower sense of control. Response options consist of a Likert scale which ranges from 1, strongly disagree to 4, strongly agree [4-point]. The items are summed, with higher scores indicating greater mastery/self-efficacy.
Measured: 9 weeks
The Depression Anxiety Stress Scales 21 (DASS-21)
The Depression Anxiety Stress Scales 21 (DASS-21) is a self-report instrument designed to measure and assess levels of depression, anxiety, and stress in individuals. It is a shortened version of the DASS-42, consisting of 21 questions. The DASS-21 is intended to provide a quick and efficient overview of an individual's mental health.
The scoring for the Depression Anxiety Stress Scales 21 (DASS-21) involves calculating separate scores for each of the three subscales: Depression, Anxiety and Stress. Each subscale contains seven items, and participants rate the extent to which they have experienced each symptom over the past week on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). DASS-21 provides separate scores for each subscale, where higher scores on each subscale indicate higher levels of depression, anxiety or stress.
Measured: the last week
Acceptance of chronic health conditions scale (ACHC)
The Acceptance of Chronic Health Conditions (ACHC) Scale is a self-report measure of acceptance in chronic health conditions. The ACHC Scale consists of 10 items scored on a 5-category Likert rating scale. Four items are positively worded, and 6 negatively worded. The ratings are summed; in the summation of the score the positively worded items are coded in reverse. A high total sum score indicates a high level of acceptance, and a low sum score indicates a low level of acceptance.
Measured: 9 weeks
EQ-5D-5L
A self-report instrument measuring health related quality of life, with one question for each of the five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Marking a level results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The instrument also has a visual analogue scale where 'The best health you can image' (=100) and 'The worst health you can image' (=0). This scale can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start18 Apr 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kristina Nilsson, Linkoeping University
- Investigators
- Kristina Nilsson, MSc, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332469
- Sponsor's protocol ID
- INSERT feasibility
- Acronym
- INSERT
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data as this is considered sensitive information
Publications
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.
PubMed 35272905Nilsson 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.
PubMed 37880582
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06332469
- Acronym / sponsor ID
- INSERT / INSERT feasibility
- Conditions
- Chronic Kidney Diseases
- Keywords
- kidney transplantation, psychosocial support, patient education, e-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Internet based education and support program for patients awaiting kidney transplantationThis group gets immediate access to the program |
| Wailtlist group | No intervention | –This group gets access to the same program after a 9 week waiting time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Not considering themselves able to spend 3-4 hours/week to work in the program
- Another illness that permanently renders kidney transplantation impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet based education and support program for patients awaiting kidney transplantationA 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. | Behavioural | Treatment group |
Primary outcome
Kidney transplant understanding tool (K-TUT)
Time frame: 9 weeks
The Kidney Transplant Understanding Tool (K-TUT) is an instrument to assess patient knowledge about kidney transplantation, consisting of 9 true and false, and 13 multiple-choice questions (each with more than 1 potential answer). In total, 69 items address several aspects related to kidney transplantation. Each statement is dichotomized ("correct" or "incorrect"). One point is given for each correct answer chosen, and the scores are summed and converted to percentages. A perfect score (100%) equates to a total of 69 points.
Self-care in chronic illness inventory v.4c
Time frame: 9 weeks
A self-report instrument with four scales; the self-care maintenance scale has 7 items, the self-care monitoring scale has 5 items, the self-care management scale has 6 items, and lastly the self-care confidence scale has 10 items. The latter was added after studies showed that self-efficacy is a major predictor of self-care. Each SC-CII item is measured using a 5-point likert scale ranging from "Never" (1) to "Always" (5), "Not likely" (1) to "Very likely" (5) and "Not confident" (1) to "Very confident" (5). The scales use a standardized score from 0 to 100, with higher scores indicating better self-care.
The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G
Time frame: 9 weeks
The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G) is a tool designed to assess an individual's confidence in their ability to manage the various aspects of living with a chronic illness. It is a short form of the original Self-Efficacy for Managing Chronic Disease 8-item Scale (SES8G). The scoring involves participants rating their confidence on a numerical scale (e.g., from 1 to 10) for each item. The scores are summed to obtain a total score. Higher scores indicate greater self-efficacy in managing chronic disease, reflecting a higher level of confidence in one's ability to handle the challenges associated with the condition.
Pearlin Mastery Scale
Time frame: 9 weeks
The Pearlin Mastery Scale is a self-report instrument designed to measure the extent to which individuals perceive control over their lives and events that affect them. It assesses the concept of "psychological mastery," which refers to an individual's perceived ability to control and influence outcomes in their life. The Pearlin Mastery Scale consists of 7 items where respondents are asked to rate their level of agreement or disagreement with each statement, reflecting their perceived mastery or control. The scale is scored by summing the responses to the individual items, providing an overall score that indicates the level of perceived mastery. Higher scores suggest a greater sense of mastery or perceived control, while lower scores may indicate a lower sense of control. Response options consist of a Likert scale which ranges from 1, strongly disagree to 4, strongly agree [4-point]. The items are summed, with higher scores indicating greater mastery/self-efficacy.
The Depression Anxiety Stress Scales 21 (DASS-21)
Time frame: the last week
The Depression Anxiety Stress Scales 21 (DASS-21) is a self-report instrument designed to measure and assess levels of depression, anxiety, and stress in individuals. It is a shortened version of the DASS-42, consisting of 21 questions. The DASS-21 is intended to provide a quick and efficient overview of an individual's mental health. The scoring for the Depression Anxiety Stress Scales 21 (DASS-21) involves calculating separate scores for each of the three subscales: Depression, Anxiety and Stress. Each subscale contains seven items, and participants rate the extent to which they have experienced each symptom over the past week on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). DASS-21 provides separate scores for each subscale, where higher scores on each subscale indicate higher levels of depression, anxiety or stress.
Acceptance of chronic health conditions scale (ACHC)
Time frame: 9 weeks
The Acceptance of Chronic Health Conditions (ACHC) Scale is a self-report measure of acceptance in chronic health conditions. The ACHC Scale consists of 10 items scored on a 5-category Likert rating scale. Four items are positively worded, and 6 negatively worded. The ratings are summed; in the summation of the score the positively worded items are coded in reverse. A high total sum score indicates a high level of acceptance, and a low sum score indicates a low level of acceptance.
EQ-5D-5L
Time frame: 9 weeks
A self-report instrument measuring health related quality of life, with one question for each of the five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Marking a level results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The instrument also has a visual analogue scale where 'The best health you can image' (=100) and 'The worst health you can image' (=0). This scale can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 35272905Nilsson 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.
- Background: PubMed 37880582Nilsson 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.
- The study web platform where study information is available and potential participants can register their interest of participation.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data as this is considered sensitive information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Nilsson, MSc principal investigator
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet based education and support program for patients awaiting kidney transplantation in people with Chronic Kidney Diseases, run by Linkoeping University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney transplant understanding tool (K-TUT) (time frame: 9 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332469, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.