Hybrid Dissemination Study of A Digital-Analog Intervention to Increase Live Donor Kidney Transplantation (KIDNEYTIME+)

University at Buffalo (UB)

Status: Begins enrollment in 10 months

Conditions: Chronic Kidney Diseases; End-Stage Renal Disease; Kidney Transplant; Living Kidney Donor

Treatments: Behavioral: Digital education outreach intervention for kidney transplant access only (unguided); Behavioral: Digital education outreach intervention for kidney transplant access and human guide

Study type: Interventional

Funder types: Other

Identifiers

NCT07072767

STUDY00014971

Details and patient eligibility

About

The study is a 2-arm randomized controlled trial among patients referred for kidney transplant evaluation at a single transplant center to compare the effects of a digital-analog intervention to increase living-donor kidney transplant access (KidneyTIME+) with or without human guide . Following consent and baseline assessment, participants are randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME+ intervention with or without human guide.

Full description

Over a 3-year period the investigators will conduct a pilot 2-arm parallel randomized trial among patients referred for kidney transplantation at a single transplant center to compare the effects of KidneyTIME+ with or without ongoing human support for KTX access over 6 months of intervention use and follow-up.

Participants will be recruited from the Transplant program at Erie County Medical Center, a safety-net hospital in Buffalo, New York. Each week, electronic records will be accessed to identify patients and their carers who present for transplant evaluation at the transplant center for a kidney transplant, are aged 18 years and older, speak English, and are competent to provide informed consent . The investigators will exclude patients previously exposed to any component of the intervention, listed for transplantation at another center, and seeking multiorgan transplantation.

A stakeholder Advisory Council, whose members include patients and care partners, will review and provide ongoing feedback on the recruitment and retention plan. They will also provide input on assistive dissemination tools for organizations to engage individuals to use the resource.

Each potential participant will be invited to the study by a researcher who will describe the study and answer and questions, and provide a copy of the consent form describing study procedures and potential risks.

Those who sign electronic consent to participate will be asked to complete a baseline sociodemographic and pre-test survey. Upon completion, computer-generated randomization will stratify participants by self-reported race (Black versus Other), with equal allocation to 2 treatment arms: the KidneyTIME+ intervention with or without human guide. Condition assignment of each participant will be concealed from transplant providers, but participants will become aware of their treatment assignment once they access the human guide.

KidneyTIME+ is a digital-analog intervention with human support. It is based on animated video education targeted to patients, donors, and support persons, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. Other key components include (1) personalized donor outreach materials, (2) email reminders about study resources, and (3) practical assistance to ensure access to intervention, advise use the intervention and encourage outreach actions. All components of the intervention were developed through a user-centered design approach by involving kidney failure patients and social network members, to improve usability and increase the likelihood of uptake.

In both intervention and control arms, the investigators chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. The video content sets the stage for the intervention and introduces the viewer to an overview of LDKT, including addressing common misconceptions about live kidney donation, donor eligibility, donor evaluation, kidney paired donation, donation costs, and donor recovery. After completing the proscribed videos everyone then receives weekly emails with links to the full video curriculum centralized on a website and other local resources. Email messages introduce study videos and features and local resources that may interest users, provide access links, and encourage video viewing and sharing. Messages will be personalized with the participants name and provide researchers contact information. The videos on the website are activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website also contains templates and examples for other donor outreach materials and practical engagement materials to promote awareness of the website. The website is open access from any electronic device. Finally, at clinic appointments participants will receive practical assistance to use intervention materials.

In the intervention arm, donor outreach will be supported by telephonic human guides who will provide tailored implementation support in 7 areas that include ensuring access, advising use, recommending features, encouraging donor outreach, and referrals to clinical services, support groups, community resources. Human guides will interact with participants over a 6-month period.

Control participants will not receive human guide support.

All participants routinely receive educational materials from non-study sources through usual Transplant Center protocols including written materials and clinical provider communications. Providers may recommend the study website or individuals may find it on their own.

After completing the proscribed video education, all participants will be invited to fill out serial surveys at 6 months post-evaluation. Participants will receive up to 6 reminders (5 automatic and 1 personalized) to complete surveys. At study conclusion, participants may be invited to an exit interview.

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• referred to the transplant center for a kidney transplant
• aged 18 years and older
• speaks English

Exclusion criteria

• Previously exposed to any component of the intervention
• Listed for a kidney transplant at another center (multilisted)
• Seeking multiorgan transplantation

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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430 participants in 2 patient groups

KidneyTime-2 with human support

Experimental group

Description:

KidneyTIME-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Human guide support offered over a 6 month period to encourage use of the intervention and donor outreach.

Treatment:

Behavioral: Digital education outreach intervention for kidney transplant access and human guide

KidneyTime-2 without human support

Active Comparator group

Description:

KidneyTime-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Routine clinical support from non-study sources through usual Transplant Center protocols including clinic provider communications.

Treatment:

Behavioral: Digital education outreach intervention for kidney transplant access only (unguided)