Digital Counseling for Chronic Kidney Disease

(ODYSSEE-KH Trial)

Overseen By Janice Montbriand, Phd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Previous transplant, Severe co-morbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 19 months

344 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ODYSSEE-KH for chronic kidney disease?

The ODYSSEE-KH treatment is a digital counseling program designed to help people with chronic kidney disease manage their condition better. Research shows that self-management tools like this can improve the quality of life for these patients by promoting self-care behaviors and supporting their overall health. ^{1 2 3 4 5}

Is digital counseling for chronic kidney disease safe for humans?

The available research does not provide specific safety data for the digital counseling program ODYSSEE Kidney Health, but it is designed to support self-care behaviors in chronic kidney disease patients, which generally suggests a focus on improving quality of life rather than introducing new risks. ^{2 6 7 8 9}

What makes the ODYSSEE-KH treatment unique for chronic kidney disease?

ODYSSEE-KH is unique because it is a digital counseling program designed to help patients with chronic kidney disease manage their condition through self-care behaviors, using easily accessible digital tools to improve their quality of life. ^{2 10 11 12 13}

What is the purpose of this trial?

INTRODUCTION Severe CKD is defined as a risk of greater than 10% for progressing to RRT \[home hemodialysis (HHD), home peritoneal dialysis (HPD), and transplantation\] within 2 years. There is a need to improve access to CKD self-care counselling and RRT education for patients with severe CKD. Trials of CKD self-care education have achieved therapeutic benefits with moderate to high patient-provider contact. There is high potential for a trial of digital counselling for CKD self-care and RRT education to enhance patient health and quality of life. HYPOTHESES The primary hypothesis is that ODYSSEE-KH versus usual care (UC) will significantly increase the incidence of home RRT, measured by a composite index of HHD, HPD, and preemptive kidney transplant at trial completion (median = 19 months; range: 12 to 27 months). The secondary hypothesis is that ODYSSEE-KH for CKD self-care and RRT education improves Home RRT, RRT preparation, annual hospitalization rate, engagement with CKD self-care resources at months 6 and 12 and trial completion and scores on outcome measures. RECRUITMENT Patients diagnosed with CKD who are 18 years of age or older were recruited from University Health Network (UHN), Sunnybrook Hospital, Scarborough Health Network, and The Ottawa Hospital. DESIGN ODYSSEE-KH is a double-arm, parallel-group, randomized controlled trial that has assessments at baseline, months 6 and 12, and trial completion (median = 19 months; range: 12 to 27 months). This is a single-blind design with research personnel masked. ODYSSEE-KH combines automated digital counselling of CKD self-care with renal replacement therapy (RRT) education. UC enhances the standard of usual care by providing patients with conventional digital CKD education. Over 27 months, patients will be emailed on a weekly basis with a digital link to log on to their respective program using a password-protected, personal account. ANALYSIS Separate GLMs will evaluate if Digital Counselling versus UC is independently associated with outcomes at months 6 and 12 and trial completion (median = 19; range: 12 to 27 months). Dependent variables include the KDQOL-SF, SF-36, EUROIA, PHQ-9, GAD-7, MIDLS, ESSI, PWB, BMPN, AI, as well as a modified SEMCD-6. Multivariable models will adjust for baseline assessments of each outcome and potential baseline covariates (noted above). In all GLMs, significant interactions will be followed by subgroup analyses with Bonferroni post hoc tests.

Research Team

Robert Nolan, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

The ODYSSEE Kidney Health Trial is for adults diagnosed with severe chronic kidney disease (CKD) who are at high risk of needing renal replacement therapy like dialysis or a kidney transplant within the next two years. Participants are recruited from specific hospitals and must be willing to engage in digital counseling and education about CKD self-care.

Inclusion Criteria

At least a basic level of self-reported computer literacy

Access to the internet and a computer

I am over 18, have a high risk of needing dialysis soon, and am seeing a kidney specialist.

Exclusion Criteria

My doctor expects I have less than 2 years to live due to my condition.

I have had a kidney transplant or am on the waitlist for one.

I do not have severe health issues like dementia or major depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital counselling for CKD self-care and RRT education, with weekly email links to digital sessions

19 months

Weekly digital sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Trial Completion Assessment

Final assessments of primary and secondary outcomes, including incidence of home RRT and self-reported measures

1 month

Treatment Details

Interventions

• ODYSSEE-KH

Trial Overview This trial tests a digital counseling program called ODYSSEE-KH against usual care over 27 months. It aims to see if this program increases home-based renal replacement therapies and improves patient engagement, hospitalization rates, and quality of life through regular online educational content.

Participant Groups

Group I: ODYSSEE-KH Experimental Treatment 1 Intervention

Participants in the intervention arm of the trial will have full access to digital counselling materials for CKD self-care and RRT education. Program engagement is dynamic with videos, digital handouts, animated charts, infographics, interactive digital trackers, and self-assessment forms. Patients will receive weekly email links to digital sessions (Supplements 1 and 2). Initial sessions will build motivation for therapeutic change. Subsequent sessions follow CBT guidelines. Finally, a monthly video posted on ODYSSEE will address common challenges and patient comments or queries.

Group II: Usual care (UC) Active Control 1 Intervention

UC is the standard of usual care which provides patients with conventional digital CKD education

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

Scarborough General Hospital

Collaborator

Trials

11

Recruited

6,500+

Findings from Research

The PREPARE NOW study is testing a new approach called 'Patient Centered Kidney Transition Care' in eight outpatient nephrology clinics to improve how patients transition from chronic kidney disease to kidney failure, focusing on their individual needs and preferences.

This intervention includes new electronic health tools and a dedicated 'Kidney Transitions Specialist' to enhance patient support and communication, with outcomes being measured over 36 months to evaluate its effectiveness compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting patients at the center of kidney care transitions: PREPARE NOW, a cluster randomized controlled trial. Green, JA., Ephraim, PL., Hill-Briggs, FF., et al.[2023]

The ODYSSEE Kidney Health program was developed using a user-centered design approach, involving 11 participants from nephrology clinics, which ensured that the program met the needs and preferences of patients with chronic kidney disease (CKD).

Participants reported high satisfaction with the program's navigation, layout, and content, highlighting its potential to positively impact their daily self-management of CKD and improve their health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Development of a Digital Counseling Program for Chronic Kidney Disease. Ong, SW., Wong, JV., Auguste, BL., et al.[2022]

This study will evaluate the effectiveness of combining early education about chronic kidney disease (CKD) with motivational interviewing-based health coaching to improve blood pressure control in 350 patients with CKD stages 3-5 over 12 months.

The innovative approach emphasizes a multidisciplinary team and off-site coaching, aiming to enhance patient knowledge and motivation, which could lead to better health outcomes and sustainable interventions for managing CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial. Wright Nunes, JA., Resnicow, K., Richardson, C., et al.[2023]

A quality improvement project successfully increased attendance at kidney replacement therapy (KRT) education sessions for patients with advanced chronic kidney disease (CKD stage 4 and 5) by offering virtual education options, especially beneficial during and after the COVID-19 pandemic.

The virtual sessions provided greater accessibility for patients, reducing travel costs and accommodating those with work or other commitments, ultimately improving patient engagement in their treatment education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement Initiative to Increase Modality Education in a Nephrology Clinic During the COVID-19 Pandemic. Prakash, S., Rabbitt, C., Danylyuk, I., et al.[2023]

A scoping review will be conducted to assess the feasibility and effectiveness of mobile health (mHealth) education for patients with chronic kidney disease (CKD), addressing a gap in current evidence regarding its outcomes and implementation challenges.

The review will analyze both quantitative and qualitative data from various studies, providing insights into patient and provider perceptions of mHealth interventions for CKD, which could inform future healthcare strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth education for patients with chronic kidney disease: protocol for a scoping review. Schultz, ANØ., Kampmann, JD., Kidholm, K., et al.[2022]

In a 1-year study involving 182 outpatients with advanced chronic kidney disease (CKD), the eKidneyCare app significantly reduced medication discrepancies compared to the MyMedRec app, indicating better medication management.

eKidneyCare not only lowered the total number of discrepancies but also reduced the severity of clinically relevant discrepancies, including those that could potentially cause serious harm, highlighting its effectiveness in improving medication safety for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Ong, SW., Jassal, SV., Porter, EC., et al.[2023]

In a study of 300 adult patients with chronic kidney disease (CKD), 40.7% experienced adverse drug events (ADEs), highlighting the high prevalence of medication-related complications in this population.

Out of the 159 reported ADEs, 30.2% were deemed preventable, suggesting that the involvement of clinical pharmacists in monitoring medication use could significantly reduce these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in hospitalized patients with chronic kidney disease. Hassan, Y., Al-Ramahi, RJ., Aziz, NA., et al.[2022]

Patients with stage 3 and 4 chronic kidney disease (CKD) are at high risk for adverse drug events (ADEs) due to the kidneys' role in medication clearance, highlighting the need for effective monitoring systems.

Interviews with clinics revealed significant differences in electronic decision support practices and organizational culture, which are crucial factors to consider when implementing electronic drug-disease alerts to reduce ADEs in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the diffusion of innovations theory to assess socio-technical factors in planning the implementation of an electronic health record alert across multiple primary care clinics. Lin, CP., Guirguis-Blake, J., Keppel, GA., et al.[2018]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

A mobile app designed for patients with stage 3-4 nondialysis-dependent chronic kidney disease (CKD) was developed with input from patients and healthcare providers, focusing on enhancing self-management through features like health data tracking, goal setting, and communication with care providers.

The app aims to improve patient-provider communication and support self-care activities, which can lead to better treatment adherence and overall management of CKD, potentially delaying kidney failure and reducing cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Support Self-management of Chronic Kidney Disease: Development Study. Markossian, TW., Boyda, J., Taylor, J., et al.[2022]

The implementation of digital health tools in four chronic kidney disease clinics successfully identified 1,032 patients, with 24% classified as high-risk for kidney failure, demonstrating the efficacy of these tools in patient management.

The digital tools improved shared decision-making, as evidenced by 91% of patients completing a values clarification tool and 87% having their treatment preferences documented in the electronic health record, indicating high acceptability and usability among patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study. Green, JA., Ephraim, PL., Hill-Briggs, F., et al.[2022]

This scoping review aims to gather and analyze existing knowledge on the participation of patients undergoing hemodialysis in two-way eHealth communication with health professionals, highlighting the need for better understanding of barriers and facilitators to patient involvement.

The study will systematically review various types of eHealth communication interventions and their impact on patient participation, with results expected to inform future developments in eHealth solutions for chronic kidney disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions, Participative Role, Barriers, and Facilitators for Involvement in eHealth Communication for People Undergoing Hemodialysis: Protocol for a Scoping Review. Deinboll, A., Moe, CF., Ludvigsen, MS.[2022]

eHealth self-management interventions for chronic kidney disease (CKD) patients can improve proximal health outcomes, such as blood pressure control and medication adherence, although results for more distant outcomes like quality of life are mixed.

The effectiveness of these interventions is influenced by the ability of healthcare professionals to monitor patients online, and there is a need for more detailed descriptions of intervention components to strengthen the evidence base and facilitate broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Health Self-Management Interventions for Patients With Chronic Kidney Disease: Systematic Review of Quantitative and Qualitative Evidence. Shen, H., van der Kleij, RMJJ., van der Boog, PJM., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Putting patients at the center of kidney care transitions: PREPARE NOW, a cluster randomized controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Design and Development of a Digital Counseling Program for Chronic Kidney Disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Quality Improvement Initiative to Increase Modality Education in a Nephrology Clinic During the COVID-19 Pandemic. [2023]

5. England pubmed.ncbi.nlm.nih.gov

mHealth education for patients with chronic kidney disease: protocol for a scoping review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Adverse drug events in hospitalized patients with chronic kidney disease. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Using the diffusion of innovations theory to assess socio-technical factors in planning the implementation of an electronic health record alert across multiple primary care clinics. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

A Mobile App to Support Self-management of Chronic Kidney Disease: Development Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Interventions, Participative Role, Barriers, and Facilitators for Involvement in eHealth Communication for People Undergoing Hemodialysis: Protocol for a Scoping Review. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Electronic Health Self-Management Interventions for Patients With Chronic Kidney Disease: Systematic Review of Quantitative and Qualitative Evidence. [2020]