Social Support Counseling for Kidney Transplant Candidates

(JtT Trial)

Overseen By Allyson Hart, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hennepin Healthcare Research Institute

Disqualifiers: Prisoners, Impaired consent, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether extra virtual coaching can assist individuals preparing for a kidney transplant. It focuses on providing social support counseling to determine if it improves the transplant process and outcomes. Participants will either receive the usual counseling or additional sessions with their social network to enhance support. The trial seeks English-speaking adults already being evaluated for a kidney transplant who are willing to include two members of their social network in the process. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance support systems for future 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 prior data suggests that this social support network counseling intervention is safe for kidney transplant candidates?

Research has shown that more social support can improve health outcomes for people with long-term illnesses, such as severe kidney disease. For this reason, researchers are exploring social support network counseling as a treatment option.

Previous studies have found that social support can enhance patients' mental and emotional health. These studies did not identify any serious negative effects, indicating that this type of counseling is generally safe.

Social support network counseling involves additional meetings with patients and their support networks, such as family or friends. The goal is to help everyone understand the process and challenges of a kidney transplant. To date, no major safety issues have been reported with this approach.

Since this is not a drug-based treatment, it focuses on providing emotional and social support rather than medical intervention, which usually involves fewer risks. However, as with any new treatment, participants should discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Social Support Network Counseling Intervention for kidney transplant candidates because it emphasizes a holistic approach to patient care by integrating the patient’s social support system into the pre-transplant counseling process. Unlike the standard of care, which typically focuses solely on the individual, this method involves family and friends in a dedicated counseling session. This new approach aims to bolster the emotional and psychological readiness of patients, potentially improving outcomes and satisfaction by addressing the broader social dynamics that impact recovery and long-term health.

What evidence suggests that Social Support Network Counseling is effective for kidney transplant candidates?

Research has shown that more social support can improve well-being for people with long-term illnesses, such as severe kidney disease. Studies have found that a strong network of family and friends helps patients manage stress and enhances their health. This trial will compare two approaches: the usual pre-transplant counseling intervention and the Social Support Network Counseling Intervention. Participants in the intervention arm will have an additional pre-transplant counseling session with their social support networks. Involving family and friends in these sessions may help patients feel more supported and prepared for the transplant process. This approach aims to address patients' needs and challenges, potentially leading to better health outcomes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

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

People who are in prison.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Social Support Network Counseling 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.

How Is the Trial Designed?

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+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06147076

Social Support Counseling Intervention for Kidney ... Social support counseling intervention for kidney transplant candidates along with their social support networks. What is the study measuring? Primary Outcome ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8957747/

Journey to Transplant: Developing a social support ... These data were used to identify specific barriers and unmet needs for kidney transplant candidates and their social support networks, and ...

3. trialx.com trialx.com/clinical-trials/listings/275421/social-support-counseling-intervention-for-kidney-transplant-candidates/?&radius=50

Social Support Counseling Intervention for Kidney ... Individuals who are eligible for kidney transplant will be recruited by phone or email and randomized into two groups, control and interventional counseling.

4. withpower.com withpower.com/trial/phase-kidney-transplantation-11-2023-61645

Social Support Counseling 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 ...

5. researchgate.net researchgate.net/publication/357305530_Journey_to_Transplant_Developing_a_social_support_network_counselling_intervention_to_improve_kidney_transplantation

(PDF) Journey to Transplant: Developing a social support ... This intervention was designed for kidney transplant candidates along with members of their social support networks and guided by a transplant healthcare ...

6. reporter.nih.gov reporter.nih.gov/project-details/8512716

Impact of perceptions on choice of kidney transplant ... Virtual coaching for potential kidney transplant candidates and their social support networks ... Transplantation Outcomes Network (APOLLO) Scientific Data ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/15/NCT04363515/Prot_000.pdf

A feasibility pilot study for a social support intervention in ... Title: A feasibility pilot study for a social support intervention in kidney transplant candidates. NCT Number: NCT04363515. Date: October 1 ...