Health Coaching for Lung Transplant Candidates

Recruiting at 2 trial locations

Overseen By Cassie L Zell, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Non-English, Nonverbal, others

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

Compensation: Varies

Number of Visits: 12

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if health coaching can help individuals waiting for a lung transplant manage their health more effectively. Participants will receive up to 12 coaching sessions over the phone, and their outcomes will be compared to those who receive only the usual care and education. The study seeks English-speaking lung transplant candidates on the waiting list at Mayo Clinic Rochester, Mayo Clinic Florida, or the University of Washington. Candidates waitlisted or deferred for a lung transplant at these locations may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance health management for future lung transplant patients.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this health coaching intervention is safe for lung transplant candidates?

Research has shown that health coaching is generally safe. In a small initial study, phone-based health coaching helped patients enhance their self-care skills and emotional well-being before a transplant, with no major safety concerns reported.

Other studies have examined health coaching for caregivers of transplant patients and found no serious safety issues. Coaching often focuses on improving habits and skills, which most people manage well. However, as with any program, individual experiences can differ.

Overall, health coaching appears to be a safe option for supporting lung transplant candidates. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about health coaching for lung transplant candidates because it offers a personalized approach that enhances self-management skills alongside standard education. Unlike typical pre-transplant preparation, which focuses mainly on medical education, health coaching provides individualized guidance to help patients actively manage their health. This method empowers patients to make informed decisions and potentially improves their readiness for surgery, which could lead to better overall outcomes.

What evidence suggests that health coaching is effective for lung transplant candidates?

Research has shown that health coaching can greatly benefit individuals awaiting a lung transplant. In this trial, participants in the health coaching arm will collaborate with a health coach to enhance self-management skills while also receiving standard pre-transplant education. Earlier studies found that patients who received health coaching managed their health more effectively and felt emotionally stronger before their transplants. These patients took better care of themselves and felt more prepared for the transplant. Health coaching involved regular phone calls to provide guidance and support. These calls aim to help patients adhere to their care plans and boost their confidence in managing their health. ^{1 2 3 6 7}

Who Is on the Research Team?

Cassie C Kennedy, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults who are on the waitlist or have been deferred for a lung transplant at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington. Participants must be able to speak and understand English and not have severe hearing difficulties.

Inclusion Criteria

Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington

Exclusion Criteria

Non-English speaking, nonverbal, or extremely hard of hearing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Health Coaching Intervention

Participants receive up to 12 health coaching sessions via phone call over a 12-16 week period

12-16 weeks

Up to 12 sessions (phone call)

Follow-up

Participants are monitored for changes in CRQ scores and quality of life post-intervention

12-16 weeks

Post-Transplant Follow-up

Participants are followed for quality of life and CRQ scores up to one year post-transplant

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Health Coaching

Trial Overview The study is testing if health coaching can improve patient outcomes before a lung transplant. It involves up to 12 phone call sessions over 3-4 months, compared with standard pre-transplant care and education.

How Is the Trial Designed?

Group I: Health Coaching Experimental Treatment 1 Intervention

Patient will work with a health coach to improve self-management skills, and receive usual pre-transplant education.

Group II: Control Active Control 1 Intervention

Patients will receive usual pre-transplant education.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A pilot study involving 30 lung transplant recipients showed that a combination of group education and telephone coaching led to trends of lower weight gain and improved body composition compared to standard care over 12 months.

While the results were not statistically significant, the intervention group experienced less increase in weight, fat mass, and waist circumference, suggesting it may be a beneficial approach for managing weight post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we HALT obesity following lung transplant? A Dietitian- and Physiotherapy-directed pilot intervention. Emsley, C., Snell, G., Paul, E., et al.[2022]

A 12-week tele-coaching intervention for lung transplant recipients was found to be feasible and well-accepted, with 86% of participants enjoying the program and no adverse events reported.

Participants in the tele-coaching group significantly increased their daily steps and movement intensity compared to the usual care group, indicating that this intervention can effectively enhance physical activity levels post-lung transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a physical activity behavioural modification tele-coaching intervention in lung transplant recipients. Hume, E., Muse, H., Wallace, K., et al.[2022]

Lung transplant candidates experience significant psychosocial distress due to their life-threatening conditions and the transplant process, highlighting the need for effective support systems.

Informal social support networks are crucial for these candidates, but they are most effective when combined with formal interventions, emphasizing the importance of tailored psychosocial management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and management of psychosocial stress in lung transplant candidates. Toronto Lung Transplant Group. Bright, MJ., Craven, JL., Kelly, PJ.[2019]

A study of 96 lung transplantation candidates revealed they were significantly inactive, spending only 5% of their waking hours walking, which highlights the need for increased physical activity before surgery.

The distance they could walk in 6 minutes (6MWD) was the strongest predictor of their daily activity levels, suggesting that improving walking ability could enhance overall physical activity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of physical activity in daily life in candidates for lung transplantation. Langer, D., Cebrià i Iranzo, MA., Burtin, C., et al.[2012]

In a pilot trial involving 30 lung transplant recipients, the Pocket PATH device significantly improved self-care agency and self-care behaviors compared to standard care during the first two months post-transplant.

Patients using Pocket PATH also reported better health-related quality of life (HRQOL), suggesting that this intervention could enhance overall well-being in lung transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a hand-held, computer-based intervention to promote early self-care behaviors after lung transplant. DeVito Dabbs, A., Dew, MA., Myers, B., et al.[2021]

Health coaching significantly improved self-efficacy and respiratory function in 54 patients with chronic obstructive pulmonary disease (COPD), indicating its potential as an effective intervention for enhancing patient outcomes.

The study also found that health coaching led to better treatment adherence compared to a control group, suggesting it can positively impact the quality of life for individuals with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of health coaching on treatment adherence, self-efficacy, and quality of life in patients with chronic obstructive pulmonary disease. Tülüce, D., Kutlutürkan, S.[2018]

Coaching, particularly through a combination of in-person and telecoaching sessions, has been shown to effectively reduce body measurements and enhance motivation and satisfaction in patients seeking weight loss, based on a review of 13 studies.

The study suggests that coaching is a cost-effective approach that integrates education and treatment for weight loss, but further randomized studies are necessary to confirm its impact on chronic disease indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching and barriers to weight loss: an integrative review. Muñoz Obino, KF., Aguiar Pereira, C., Caron-Lienert, RS.[2022]

This review analyzed five studies on life coaching interventions in healthcare, finding that while the evidence is limited, some patients, particularly those who typically do not respond well to standard interventions, showed promising improvements in health outcomes like HbA1c levels.

The studies suggest that life coaching may enhance self-efficacy and self-empowerment, indicating that alternative communication and approaches in patient care can lead to better engagement and outcomes for disadvantaged patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can life coaching improve health outcomes?--A systematic review of intervention studies. Ammentorp, J., Uhrenfeldt, L., Angel, F., et al.[2022]

A home-based intervention using wearable accelerometers and financial incentives successfully increased physical activity among kidney and liver transplant recipients, with participants in the intervention group achieving significantly more steps than the control group.

Despite the increase in physical activity, the intervention did not lead to significant weight change after 3 months, indicating that while promoting activity is feasible, it may not directly impact weight loss in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled, behavioral intervention to promote walking after abdominal organ transplantation: results from the LIFT study. Serper, M., Barankay, I., Chadha, S., et al.[2021]

Health coaching significantly improves health-related quality of life (HRQoL) in people with chronic obstructive pulmonary disease (COPD), with a standardized mean difference of -0.69 based on a meta-analysis of 10 randomized controlled trials involving various health coaching components.

The intervention also leads to a notable reduction in COPD-related hospital admissions, with an odds ratio of 0.46, indicating that health coaching can help manage COPD more effectively and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does health coaching improve health-related quality of life and reduce hospital admissions in people with chronic obstructive pulmonary disease? A systematic review and meta-analysis. Long, H., Howells, K., Peters, S., et al.[2019]

This systematic review aims to evaluate the effectiveness of health coaching (HC) interventions for adults with chronic conditions, synthesizing studies published in the last four years to assess patient improvement and coaching characteristics.

If health coaching is found to be effective, it could lead to broader public health applications and integration into current management strategies for chronic diseases, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. Yang, J., Bauer, BA., Lindeen, SA., et al.[2023]

A study involving 201 lung transplant recipients found that those using a mobile health (mHealth) intervention were significantly better at self-monitoring their health, adhering to their medical regimen, and reporting abnormal health indicators compared to those receiving usual care.

Despite improvements in self-management behaviors with the mHealth intervention, there were no significant differences in rehospitalization or mortality rates between the two groups, indicating that while the intervention is effective for self-management, it may not directly impact these critical health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation. DeVito Dabbs, A., Song, MK., Myers, BA., et al.[2023]

A collaborative program called 'Transplant ... and Now Sport' successfully implemented a supervised exercise regimen for 26 transplant patients, leading to significant improvements in physical fitness, including increased peak aerobic power and maximum strength.

The program also resulted in enhanced health-related quality of life scores, indicating that structured physical activity can be a beneficial part of post-transplant care, despite initial patient attitudes and access challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in solid organ transplant recipients: organizational aspects and preliminary results of the Italian project. Roi, GS., Stefoni, S., Mosconi, G., et al.[2018]

Citations

1. mayoclinic.elsevierpure.com mayoclinic.elsevierpure.com/en/projects/pre-transplant-health-coaching-to-improve-patient-reported-outcom-7

Pre-transplant health coaching to improve patient-reported ... In our small, single-center pilot trial we showed telephonic health coaching demonstrated improved pre-transplant self-management abilities, emotional health, ...

2. clinicaltrial.be clinicaltrial.be/en/details/16453?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Pre-transplant Health Coaching to Improve Patient-Reporte... To examine the effectiveness of an individual health coaching intervention for lung transplant candidates. This intervention will include up to 12 health ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20535257

Pre-transplant Health Coaching to Improve Patient ... The purpose of this study is to examine the effectiveness of a phone call ≤ 30 minute per session, 12-session, weekly individual health-coaching intervention, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04245228

Wellness Coaching for Caregivers of Thoracic Transplant ... Researchers are studying the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06428513/health-coaching-telemedicine-program-for-lung-transplant-candidates-with-end-stage-lung-disease

Health Coaching Telemedicine Program for Lung ... Investigators hypothesized that health coaching can improve health outcomes and survival of lung transplantation candidates by supporting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12505040/

1-year physical activity coaching programme in lung ... Coaching interventions aiming to improve PA show promising results in patients with respiratory diseases and organ transplant recipients. A ...

7. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.12355/full

Virtual Physical Prehabilitation in Lung Transplant Candidates This study aimed to preliminary test the effectiveness of 12-week virtual physical prehabilitation program followed by a maintenance phase.