Kidney TransplantNCT03633136
A Randomized Controlled Trial of a Pre-Transplant Education Intervention
A study testing electronic video education in people with Kidney Transplant and Patient Education, run by University of Saskatchewan at 3 sites in Canada.
Trial summary
A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life, beliefs in medications, and education satisfaction as compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Patient Education, Quality of Life
- What is being tested?
- electronic video education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jun 2018to 7 Jul 2020
- 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 or older
- can speak and understand and read English
- are being assessed or wait-listed for kidney transplantation
Who cannot join
- do not meet inclusion criteria
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Southern Alberta Transplant Program
Calgary, Alberta
Saskatchewan Transplant Program
Regina, Saskatchewan
Saskatchewan Transplant Program
Saskatoon, Saskatchewan
About this study
Official title: Improving Health Outcomes of Kidney Recipients: A Randomized Controlled Trial of a Pre-Transplant Education Intervention
A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life, beliefs in medications, and education satisfaction as compared to usual care.
Read the detailed description
Kidney transplantation is the best treatment for most patients with end-stage kidney disease, but it is an extremely complicated process. To become active on the transplant waitlist, patients must learn new information, navigate the healthcare system and undergo several specialized tests. After the transplant, another set of challenges emerge. Transplant recipients must commit to lifelong therapy with immunosuppressive medications and adapt to lifestyle changes. Up to half of all patients have difficulty taking the medications as prescribed, which can lead to transplant rejection, kidney loss, and death. The transplant process is challenging and confusing; however, increasing education and support to transplant candidates demands greater use of care providers' time and resources in a health care system that is already stretched.
A patient-oriented video series has been developed according to best practices for transplant education, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives provide support and encouragement.
A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life and beliefs in medications as compared to usual care. Participants will be randomized (1:1) to the control group, or the intervention group, who will be provided access to the video series, in addition, to standard of care. Differences in changes in transplant knowledge, self-efficacy, beliefs about medicines, quality of life, and education satisfaction will be evaluated by a pre-and post-intervention survey. A thorough assessment of video-viewing habits and satisfaction with the intervention will provide insight on the feasibility of expanding home-based education to other health settings.
- Conditions
- Kidney Transplant, Patient Education, Quality of Life
- Being tested
- electronic video education
- Keywords
- video, patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic video educationBehavioural
Also called Solid Organ Transplantation: An Educational Mini-Series for Patients
Solid Organ Transplantation: An Educational Mini-Series for Patients consists of 6 videos ranging in length between 3 and 23 minutes, and has been developed according to best practice for designing education for patients with end-stage renal disease pursuing transplant. Each video outlines a subsequent stage of the transplant process, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives keep the content relevant and culturally inclusive. The educational intervention was developed with experts in medication adherence, video education, motivational psychology, cultural education (First Nations perspective), healthcare providers, and most importantly patients.
| Study group | Role | What they receive |
|---|---|---|
| standard education | No intervention | Standard of care education provided at each transplant center |
| electronic video education | Experimental | Standard education along with home-based video education. The videos will be initially viewed in the following order: Video 1: Introduction; Video 2: The Kidney; Video 3: Assessment and Waitlist; Video 4: Operation and Recovery; Video 5: Medications; Video 6: Your New Life. After the series has been viewed in its entirety one time, participants will be able to replay a specific video as often as desired. Receives: Behavioral: electronic video education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transplant knowledge score between the intervention and control groups as measured by the Kidney Transplant Understanding Tool (K-TUT)
Measured by the Kidney Transplant Understanding Tool (K-TUT) (self-reported electronic survey). The K-TUT consists of 9 true/false and 13 multiple-choice questions, and scores are based on the number correct answers [YES/ NO format] of 69 items.
Measured: 1 month
Secondary outcomes (4)
Difference in self-efficacy between the intervention and control group as measured by the Generalized Self Efficacy Scale (GSE)
Measured by the Generalized Self Efficacy Scale (GSE) (self-reported electronic survey).The GSE measures an individual's self-beliefs in their ability to cope with various demands in life. It is a 10-item psychometric scale with a score for each item ranging from 1 to 4. The scores are summed and a higher score indicates stronger patient beliefs in self-efficacy.
Measured: 1 month
Difference in quality of life between the intervention and control group as measured by the Short Form-12 (SF-12)
Measured by the Short Form-12 (SF-12) (self-reported electronic survey). The SF-12 is a 12-item psychometric scale that measures functional health and well-being. Responses are indicated on a likert scale and aggregated into two sub scales; the mental component summary (MCS) and the physical component summary (PCS). The scores are converted to adjusted norm-based values of a healthy individual with a midpoint score of 50 indicating average health comparable to norm values.
Measured: 1 month
Difference in beliefs of medicine between the intervention and control group as measured by the Beliefs of Medicine Questionnaire (BMQ)
Measured by the Beliefs of Medicine Questionnaire (BMQ) (self-reported electronic survey). The BMQ is an 18-item psychometric questionnaire which consists of two subscales. The BMQ-Specific assesses perceptions of medication prescribed for personal use, while the BMQ-General assesses beliefs about medications in general. The BMQ-General can be further classified into domain of General-Harm and General-Overuse. Items are scored on a 5-point likert scale, with higher score indicating stronger beliefs in each subscale.
Measured: 1 month
Difference in education satisfaction between the intervention and control group as measured by self-reported electronic survey
Measured by self-reported electronic survey
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Jun 2018
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Authority - Regina Area, Southern Alberta Transplant Program, Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
- Responsible party
- Principal investigator, Holly Mansell, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633136
- Sponsor's protocol ID
- 99302
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2018
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes of Kidney Recipients: A Randomized Controlled Trial of a Pre-Transplant Education Intervention
- ClinicalTrials.gov ID
- NCT03633136
- Acronym / sponsor ID
- 99302
- Conditions
- Kidney Transplant, Patient Education, Quality of Life
- Keywords
- video, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Authority - Regina Area, Southern Alberta Transplant Program, Saskatchewan Health Research Foundation, Saskatchewan Centre for Patient-Oriented Research
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 16 Aug 2018 (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.
A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life, beliefs in medications, and education satisfaction as compared to usual care.
Detailed description
Kidney transplantation is the best treatment for most patients with end-stage kidney disease, but it is an extremely complicated process. To become active on the transplant waitlist, patients must learn new information, navigate the healthcare system and undergo several specialized tests. After the transplant, another set of challenges emerge. Transplant recipients must commit to lifelong therapy with immunosuppressive medications and adapt to lifestyle changes. Up to half of all patients have difficulty taking the medications as prescribed, which can lead to transplant rejection, kidney loss, and death. The transplant process is challenging and confusing; however, increasing education and support to transplant candidates demands greater use of care providers' time and resources in a health care system that is already stretched.
A patient-oriented video series has been developed according to best practices for transplant education, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives provide support and encouragement.
A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life and beliefs in medications as compared to usual care. Participants will be randomized (1:1) to the control group, or the intervention group, who will be provided access to the video series, in addition, to standard of care. Differences in changes in transplant knowledge, self-efficacy, beliefs about medicines, quality of life, and education satisfaction will be evaluated by a pre-and post-intervention survey. A thorough assessment of video-viewing habits and satisfaction with the intervention will provide insight on the feasibility of expanding home-based education to other health settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard education | No intervention | –Standard of care education provided at each transplant center |
| electronic video education | Experimental | Behavioral: electronic video educationStandard education along with home-based video education. The videos will be initially viewed in the following order: Video 1: Introduction; Video 2: The Kidney; Video 3: Assessment and Waitlist; Video 4: Operation and Recovery; Video 5: Medications; Video 6: Your New Life. After the series has been viewed in its entirety one time, participants will be able to replay a specific video as often as desired. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 or older
- can speak and understand and read English
- are being assessed or wait-listed for kidney transplantation
Key exclusion criteria (1 listed)
- do not meet inclusion criteria
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 |
|---|---|---|
| electronic video educationAlso: Solid Organ Transplantation: An Educational Mini-Series for PatientsSolid Organ Transplantation: An Educational Mini-Series for Patients consists of 6 videos ranging in length between 3 and 23 minutes, and has been developed according to best practice for designing education for patients with end-stage renal disease pursuing transplant. Each video outlines a subsequent stage of the transplant process, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives keep the content relevant and culturally inclusive. The educational intervention was developed with experts in medication adherence, video education, motivational psychology, cultural education (First Nations perspective), healthcare providers, and most importantly patients. | Behavioural | electronic video education |
Primary outcome
Change in transplant knowledge score between the intervention and control groups as measured by the Kidney Transplant Understanding Tool (K-TUT)
Time frame: 1 month
Measured by the Kidney Transplant Understanding Tool (K-TUT) (self-reported electronic survey). The K-TUT consists of 9 true/false and 13 multiple-choice questions, and scores are based on the number correct answers [YES/ NO format] of 69 items.
4 secondary outcomes
Difference in self-efficacy between the intervention and control group as measured by the Generalized Self Efficacy Scale (GSE)
Time frame: 1 month
Difference in quality of life between the intervention and control group as measured by the Short Form-12 (SF-12)
Time frame: 1 month
Difference in beliefs of medicine between the intervention and control group as measured by the Beliefs of Medicine Questionnaire (BMQ)
Time frame: 1 month
Difference in education satisfaction between the intervention and control group as measured by self-reported electronic survey
Time frame: 1 month
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 16 Aug 2024.
- project websiteLink provided by the sponsor.
- Study ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
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RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic video education in people with Kidney Transplant and Patient Education, run by University of Saskatchewan at 3 sites in Canada.
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 3 inclusion and 1 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Change in transplant knowledge score between the intervention and control groups as measured by the Kidney Transplant Understanding Tool (K-TUT) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.