Kidney TransplantationVECTORNCT03540121
Video Education and Behaviour Contract to Optimize Adherence in Renal Transplants
A study testing Video education + adherence contract in people with Kidney Transplantation and Medication Adherence, run by University of Saskatchewan at 3 sites in 2 countries.
Trial summary
This study aims to test the effectiveness of an electronic-based video intervention and behavioral contract on improving medication adherence among kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Medication Adherence
- What is being tested?
- Video education + adherence contract
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2018to 31 Dec 2022
- 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
- receive their first kidney transplant at one of the participating sites during enrolment
Who cannot join
- do not meet inclusion criteria
- have previously participated in a study entitle "Improving health outcomes of kidney recipients: A randomized controlled trial of a pre-transplant education intervention"
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Southern Alberta Transplant Program
Calgary, Alberta
Saskatchewan Transplant Program
Saskatoon, Saskatchewan
United States1 site
University of Illinois Health Sciences System
Chicago, Illinois, 60612
About this study
Official title: Improving Adherence in Kidney Recipients: a Randomized Controlled Trial of a Post-transplant Education Intervention
This study aims to test the effectiveness of an electronic-based video intervention and behavioral contract on improving medication adherence among kidney transplant recipients.
Read the detailed description
Non-adherence to immunosuppressive medications is a major problem after kidney transplantation, leading to increased rejections, hospitalizations and health care expenditures. Effective educational opportunities may positively influence adherence, especially when combined with a behavior intervention. However, increasing education and support to transplant recipients 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 multicenter randomized controlled trial will be conducted with 4 sites across North America. Patients will be randomized (1:1) to either the intervention (i.e., home-based video education + adherence contract plus usual care) or usual care alone. Patients will be enrolled in the study prior to hospital discharge and will be provided with access to the video intervention and contract electronically. The primary outcome will be adherence at 12 months post-transplant, as measured by self-report (BAASIS), and variability in immunosuppressant levels. Secondary outcomes include the change in knowledge score between the intervention and control in groups (measured by the Kidney Transplant Understanding Tool); differences in self-efficacy (Generalized Self-efficacy Scale), beliefs about medicines (Beliefs of Medicine Questionnaire), and quality of life (SF-12). Individualized viewing statistics will be analyzed to determine patient uptake, and satisfaction about the educational experience will be captured on a self-reported survey.
- Conditions
- Kidney Transplantation, Medication Adherence
- Being tested
- Video education + adherence contract
- Keywords
- video, contract, patient education
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video education + adherence contractBehavioural
Also called Solid Organ Transplantation: An Educational Mini-Series for Patients
Participants will receive standard education along with the home-based video education plus an adherence contract. Following the baseline assessment, access to videos will be provided electronically so that the patient can watch them at home. The videos will be initially viewed in the following order: Video 1: Introduction, Video 2: Medications, Video 3: Your New Life. Approximately one month after transplant, after the video series has been viewed in its entirety, participants will receive an email link inviting participants to reflect on their goals about transplantation and pledging to taking their medications as directed. The contract will be non-enforceable, but it will provide patients with the opportunity to formally commit to a goal of taking the medications as prescribed. At 3 months, and 12 months, the participant will have the opportunity to reflect and modify adherence goals as desired.
| Study group | Role | What they receive |
|---|---|---|
| Video education + adherence contract | Experimental | electronically delivered video education (at transplant discharge) + electronic adherence contract (1 month after enrolment) Receives: Behavioral: Video education + adherence contract |
| Standard education | No intervention | standard of care education provided at each transplant center (control emails will be provided at intervention time points) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in adherence to immunosuppressant medications between intervention and control (self-report)
The Basel Assessment of Adherence to Immunosuppressive medications (BAASIS) will be sent electronically by self-reported survey. An answer of 'yes' to any of the questions (pertaining to missing doses, drug holidays, timing, and dose reduction) will constitute non-adherence as a binary outcome. • A continuous measure of adherence will also be determined in each individual using a visual analogue scale.
Measured: 3 months and 12 months after enrolment
Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels)
Immunosuppressant levels (tacrolimus, cyclosporine or sirolimus) will be collected as per routine practice, and will be standardized to the patient specific target. Intra-patient coefficients of variation (CV) will be used as a measure of trough level variability, and percentage of sub-therapeutic levels will be determined for each patient.
Measured: 3 months and 12 months after enrolment
Secondary outcomes (9)
Difference in changes in kidney transplant knowledge between intervention and control
Measured by the Kidney Transplant Understanding Tool (K-TUT) via 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: 3 months and 12 months after enrolment
Difference in quality of life between intervention and control
Measured by the Short Form 12 (SF-12) via 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: 3 months and 12 months after enrolment
Difference in self efficacy between intervention and control
Measured by the Generalized Self-Efficacy Scale (GSE) via 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: 3 months and 12 months after enrolment
Difference in education satisfaction between intervention and control
Measured by self-report electronic survey
Measured: 3 months and 12 months after enrolment
Difference in beliefs about medication between intervention and control
Measured by the Beliefs of Medicine Questionnaire (BMQ) via 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: 3 months and 12 months after enrolment
Difference in adherence to transplant appointments between intervention and control
Captured by chart review
Measured: study end (12 months after enrolment)
Video viewing habits (duration of viewing time)
We will record the total duration that participants have watched each video (in minutes). This number will be divided by the total length of each video and used as a surrogate marker for whether each video was watched in its entirety.
Measured: study end (12 months after enrolment)
Cost of administering the intervention
Staff time and other resources used in administering the intervention will be tracked and monetized using market wages and prices.
Measured: study end (12 months after enrolment)
Days in hospital
The number of days in hospital will be collected by chart review at the end of the study period to estimate health care utilization.
Measured: study end (12 months after enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 173 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, University of Illinois Health Sciences System, American Society of Transplantation Research Network, University of Alberta Transplant Recipient Program, Vancouver Coastal Health, Providence Health, St. Pauls Hospital - Renal Transplant Program
- Responsible party
- Principal investigator, Holly Mansell, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540121
- Sponsor's protocol ID
- 99399
- Acronym
- VECTOR
- Status last verified
- Aug 2024
- First submitted
- 27 Apr 2018
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mansell H, Rosaasen N, Wichart J, West-Thielke P, Blackburn D, Liu J, Mainra R, Shoker A, Groot B, Wen K, Wong A, Bateni B, Luo C, Trivedi P. Video Education and Behavior Contract to Improve Outcomes After Renal Transplantation (VECTOR): A Randomized Controlled Trial. Patient Prefer Adherence. 2024 Jul 31;18:1589-1602. doi: 10.2147/PPA.S467142. eCollection 2024.
PubMed 39100428Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PubMed 36094829Mansell H, Rosaasen N, West-Thielke P, Wichart J, Daley C, Mainra R, Shoker A, Liu J, Blackburn D. Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol. BMJ Open. 2019 Mar 13;9(3):e025495. doi: 10.1136/bmjopen-2018-025495.
PubMed 30872550
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 Adherence in Kidney Recipients: a Randomized Controlled Trial of a Post-transplant Education Intervention
- ClinicalTrials.gov ID
- NCT03540121
- Acronym / sponsor ID
- VECTOR / 99399
- Conditions
- Kidney Transplantation, Medication Adherence
- Keywords
- video, contract, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Authority - Regina Area, Southern Alberta Transplant Program, University of Illinois Health Sciences System, American Society of Transplantation Research Network, University of Alberta Transplant Recipient Program, Vancouver Coastal Health, Providence Health, St. Pauls Hospital - Renal Transplant Program
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 May 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.
This study aims to test the effectiveness of an electronic-based video intervention and behavioral contract on improving medication adherence among kidney transplant recipients.
Detailed description
Non-adherence to immunosuppressive medications is a major problem after kidney transplantation, leading to increased rejections, hospitalizations and health care expenditures. Effective educational opportunities may positively influence adherence, especially when combined with a behavior intervention. However, increasing education and support to transplant recipients 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 multicenter randomized controlled trial will be conducted with 4 sites across North America. Patients will be randomized (1:1) to either the intervention (i.e., home-based video education + adherence contract plus usual care) or usual care alone. Patients will be enrolled in the study prior to hospital discharge and will be provided with access to the video intervention and contract electronically. The primary outcome will be adherence at 12 months post-transplant, as measured by self-report (BAASIS), and variability in immunosuppressant levels. Secondary outcomes include the change in knowledge score between the intervention and control in groups (measured by the Kidney Transplant Understanding Tool); differences in self-efficacy (Generalized Self-efficacy Scale), beliefs about medicines (Beliefs of Medicine Questionnaire), and quality of life (SF-12). Individualized viewing statistics will be analyzed to determine patient uptake, and satisfaction about the educational experience will be captured on a self-reported survey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video education + adherence contract | Experimental | Behavioral: Video education + adherence contractelectronically delivered video education (at transplant discharge) + electronic adherence contract (1 month after enrolment) |
| Standard education | No intervention | –standard of care education provided at each transplant center (control emails will be provided at intervention time points) |
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
- receive their first kidney transplant at one of the participating sites during enrolment
Key exclusion criteria (2 listed)
- do not meet inclusion criteria
- have previously participated in a study entitle "Improving health outcomes of kidney recipients: A randomized controlled trial of a pre-transplant education intervention"
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 |
|---|---|---|
| Video education + adherence contractAlso: Solid Organ Transplantation: An Educational Mini-Series for PatientsParticipants will receive standard education along with the home-based video education plus an adherence contract. Following the baseline assessment, access to videos will be provided electronically so that the patient can watch them at home. The videos will be initially viewed in the following order: Video 1: Introduction, Video 2: Medications, Video 3: Your New Life. Approximately one month after transplant, after the video series has been viewed in its entirety, participants will receive an email link inviting participants to reflect on their goals about transplantation and pledging to taking their medications as directed. The contract will be non-enforceable, but it will provide patients with the opportunity to formally commit to a goal of taking the medications as prescribed. At 3 months, and 12 months, the participant will have the opportunity to reflect and modify adherence goals as desired. | Behavioural | Video education + adherence contract |
Primary outcome
Difference in adherence to immunosuppressant medications between intervention and control (self-report)
Time frame: 3 months and 12 months after enrolment
The Basel Assessment of Adherence to Immunosuppressive medications (BAASIS) will be sent electronically by self-reported survey. An answer of 'yes' to any of the questions (pertaining to missing doses, drug holidays, timing, and dose reduction) will constitute non-adherence as a binary outcome. • A continuous measure of adherence will also be determined in each individual using a visual analogue scale.
Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels)
Time frame: 3 months and 12 months after enrolment
Immunosuppressant levels (tacrolimus, cyclosporine or sirolimus) will be collected as per routine practice, and will be standardized to the patient specific target. Intra-patient coefficients of variation (CV) will be used as a measure of trough level variability, and percentage of sub-therapeutic levels will be determined for each patient.
9 secondary outcomes
Difference in changes in kidney transplant knowledge between intervention and control
Time frame: 3 months and 12 months after enrolment
Difference in quality of life between intervention and control
Time frame: 3 months and 12 months after enrolment
Difference in self efficacy between intervention and control
Time frame: 3 months and 12 months after enrolment
Difference in education satisfaction between intervention and control
Time frame: 3 months and 12 months after enrolment
Difference in beliefs about medication between intervention and control
Time frame: 3 months and 12 months after enrolment
Difference in adherence to transplant appointments between intervention and control
Time frame: study end (12 months after enrolment)
Video viewing habits (duration of viewing time)
Time frame: study end (12 months after enrolment)
Cost of administering the intervention
Time frame: study end (12 months after enrolment)
Days in hospital
Time frame: study end (12 months after enrolment)
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.
- Derived from this study: PubMed 39100428Mansell H, Rosaasen N, Wichart J, West-Thielke P, Blackburn D, Liu J, Mainra R, Shoker A, Groot B, Wen K, Wong A, Bateni B, Luo C, Trivedi P. Video Education and Behavior Contract to Improve Outcomes After Renal Transplantation (VECTOR): A Randomized Controlled Trial. Patient Prefer Adherence. 2024 Jul 31;18:1589-1602. doi: 10.2147/PPA.S467142. eCollection 2024.
- Derived from this study: PubMed 36094829Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
- Derived from this study: PubMed 30872550Mansell H, Rosaasen N, West-Thielke P, Wichart J, Daley C, Mainra R, Shoker A, Liu J, Blackburn D. Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol. BMJ Open. 2019 Mar 13;9(3):e025495. doi: 10.1136/bmjopen-2018-025495.
- project websiteLink provided by the sponsor.
- Vector protocol, BMJ openLink provided by the sponsor.
- Study ResultsLink provided by the sponsor.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video education + adherence contract in people with Kidney Transplantation and Medication Adherence, run by University of Saskatchewan at 3 sites in 2 countries.
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 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 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, United States. 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?
Difference in adherence to immunosuppressant medications between intervention and control (self-report) (time frame: 3 months and 12 months after enrolment). The study lists 2 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 NCT03540121, which also lists 3 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 16 Aug 2024.