Social Support Counseling for Kidney Transplant Candidates

(JtT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Hennepin Healthcare Research Institute

Disqualifiers: Prisoners, Impaired consent, Pregnant, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Virtual Coaching for Potential Kidney Transplant Patients

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Social Support Network Counseling Intervention for kidney transplant candidates?

Research suggests that increased social support can improve outcomes for patients with chronic illnesses, including end-stage renal disease, by enhancing quality of life, compliance with therapies, and survival rates. Although specific studies on social support interventions for kidney transplant candidates are limited, the potential benefits of social support in similar contexts indicate that such interventions could be beneficial. ^{1 2 3 4 5}

How does the Social Support Network Counseling Intervention differ from other treatments for kidney transplant candidates?

This treatment is unique because it focuses on enhancing social support for kidney transplant candidates, helping them engage with their social networks to find potential living donors, which is not typically addressed by other treatments. ^{4 6 7 8 9}

Research Team

Eligibility Criteria

This trial is for adults over 18 who are being evaluated for a kidney transplant and can make their own medical decisions. They must speak English, be willing to involve at least two people from their social network in the sessions, and share results with them. Pregnant women and prisoners cannot participate.

Inclusion Criteria

I am unable to make medical decisions for myself.

I am 18 years old or older.

You can clearly understand and agree to take part in the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplant Counseling

Participants undergo usual pre-transplant counseling as per the standard of care

1-2 weeks

Interventional Counseling

Participants in the intervention arm undergo additional pre-transplant counseling with their social support networks

1-2 weeks

Follow-up

Participants are monitored for changes in knowledge, decisional conflict, social support, and hope index

4 weeks

Treatment Details

Interventions

• Social Support Network Counseling Intervention (Behavioral Intervention)

Trial Overview The study is testing a virtual coaching program designed to provide social support counseling to potential kidney transplant patients. It aims to see if this intervention helps improve outcomes by involving the patient's personal support network.

Participant Groups

Group I: Social Support Network Counseling Intervention Experimental Treatment 1 Intervention

Participants in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks after their initial transplant evaluation and counseling.

Group II: Usual Pre-Transplant Counseling Intervention Active Control 1 Intervention

Participants in control arm will undergo usual pre-transplant counseling as per the standard of care.

Who Is Running the Clinical Trial?

Hennepin Healthcare Research Institute

Lead Sponsor

Trials

94

Recruited

77,100+

Jennifer DeCubellis

Hennepin Healthcare Research Institute

Chief Executive Officer since 2020

M.A. from the Illinois School of Professional Psychology, B.A. from the University of Wisconsin-Madison

Dr. Eric W. Ling

Hennepin Healthcare Research Institute

Chief Medical Officer since 2024

MD from Northwestern Feinberg School of Medicine, MBA from the University of St. Thomas

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

Findings from Research

The 'Journey to Transplant' (JtT) intervention was developed using a systematic Intervention Mapping approach, which included educational counseling sessions for kidney transplant candidates and their support networks, aimed at improving knowledge and addressing emotional barriers to accessing the transplant waiting list.

The JtT intervention is designed to be effective and feasible for implementation across transplant centers, as it incorporates behavior change theory and engages patients' social support networks to help overcome specific barriers to kidney transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Journey to Transplant: Developing a social support network counselling intervention to improve kidney transplantation. D'Cunha, H., Partin, M., Kurschner, S., et al.[2022]

In a study of 239 kidney transplant patients, 36% reported low participation in obligatory activities like employment and education, with only 52.4% being employed, highlighting challenges in social functioning post-transplant.

Clinical factors such as older age, presence of comorbidities (like previous cardiovascular events), and receiving a cadaveric transplant negatively impacted participation in obligatory activities, while time since transplantation had a positive effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical factors influencing participation in society after successful kidney transplantation. van der Mei, SF., Groothoff, JW., van Sonderen, EL., et al.[2006]

Increased social support can significantly improve outcomes for patients with end-stage renal disease (ESRD) by enhancing compliance with treatment and potentially boosting survival rates, as seen in studies linking higher spousal support to better health outcomes.

Despite the promising benefits of social support, there is a lack of rigorous research on interventions in ESRD patients, highlighting the need for a large, prospective, randomized controlled trial to better understand its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social support and chronic kidney disease: an update. Cohen, SD., Sharma, T., Acquaviva, K., et al.[2007]

The Kidney Coach Program (KCP) significantly increased the number of living donor inquiries among transplant candidates, with 80% of KCP participants receiving at least one inquiry compared to only 38% of historical controls.

The study suggests that training candidates and their advocates on how to discuss living donation can effectively raise awareness and improve donor recruitment, highlighting the need for transplant programs to implement such training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing living donation by implementing the Kidney Coach Program. LaPointe Rudow, D., Geatrakas, S., Armenti, J., et al.[2020]

Patients who received kidney transplants reported a significant improvement in their quality of life across physical, emotional, and social aspects compared to those on the waiting list, highlighting the positive impact of transplantation on overall well-being.

Factors such as time spent on hemodialysis, gender, age, and the source of the organ (living vs. cadaver donor) were found to influence how well patients adjust post-transplant, indicating the need for tailored psychological care and support for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of kidney transplantation on quality of life measures. Pietrabissa, A., Ciaramella, A., Carmellini, M., et al.[2019]

A meta-analysis of 17 studies involving 2697 kidney transplant patients found that while patients received substantial economic, physical, and emotional support post-surgery, their subjective feelings of support and actual utilization of that support were generally low.

Female kidney transplant patients reported lower levels of social support utilization compared to males, indicating a need for targeted interventions by medical staff to enhance social support systems and improve overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis for Social Support Degree of Kidney Transplant Recipients: Evidence from China. Yang, Q., Xia, M., Hu, S., et al.[2023]

In a study involving 152 Black adults waiting for kidney transplants, house calls (HC) as an educational intervention significantly increased the likelihood of initiating living donor evaluations compared to group-based (GB) and individual counseling (IC) interventions.

Younger patients (under 60 years) and those with larger social networks benefited the most from the HC intervention, indicating that these factors can enhance the effectiveness of educational approaches in promoting living donor kidney transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and Moderators of Educational Interventions to Increase the Likelihood of Potential Living Donors for Black Patients Awaiting Kidney Transplantation. Rodrigue, JR., Paek, MJ., Schold, JD., et al.[2020]

Social support is linked to better health outcomes and survival rates in chronic illnesses like cancer and end-stage renal disease (ESRD), highlighting its importance in patient care.

While the exact mechanisms of how social support benefits patients are unclear, factors such as improved compliance, access to healthcare, and reduced stress are believed to contribute, suggesting that enhancing social support for ESRD patients could be beneficial and warrants further study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of social support on end-stage renal disease. Patel, SS., Peterson, RA., Kimmel, PL.[2022]

A survey of 584 transplant providers revealed that social support is the second most important factor in determining kidney transplant suitability, following adherence to medical regimens.

The influence of social support varies by provider role; psychosocial providers prioritize adherence and quality of life, while medical/surgical providers focus more on life expectancy, highlighting potential disparities in transplant decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How important is social support in determining patients' suitability for transplantation? Results from a National Survey of Transplant Clinicians. Ladin, K., Emerson, J., Butt, Z., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Journey to Transplant: Developing a social support network counselling intervention to improve kidney transplantation. [2022]

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

Clinical factors influencing participation in society after successful kidney transplantation. [2006]

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

Social support and chronic kidney disease: an update. [2007]

4. Denmark pubmed.ncbi.nlm.nih.gov

Increasing living donation by implementing the Kidney Coach Program. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of kidney transplantation on quality of life measures. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Meta-Analysis for Social Support Degree of Kidney Transplant Recipients: Evidence from China. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Predictors and Moderators of Educational Interventions to Increase the Likelihood of Potential Living Donors for Black Patients Awaiting Kidney Transplantation. [2020]

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

The impact of social support on end-stage renal disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

How important is social support in determining patients' suitability for transplantation? Results from a National Survey of Transplant Clinicians. [2022]