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

Trial Summary

What is the purpose of this trial?

To examine the effectiveness of an individual health coaching intervention for lung transplant candidates. This intervention will include up to 12 health coaching sessions via phone call over a 12-16 week period. This will be compared to a usual care group the receives pre-transplant care and education alone.

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 data supports the effectiveness of the treatment Health Coaching for Lung Transplant Candidates?

Research shows that health coaching can improve treatment adherence (sticking to a treatment plan), self-efficacy (confidence in managing one's health), and quality of life in patients with chronic conditions like chronic obstructive pulmonary disease (COPD). This suggests that similar benefits might be seen in lung transplant candidates. ^{1 2 3 4 5}

Is health coaching safe for lung transplant candidates?

The studies reviewed do not directly address the safety of health coaching for lung transplant candidates, but they suggest that similar interventions, like tele-coaching and mobile health interventions, are generally feasible and acceptable for transplant recipients, indicating no major safety concerns. ^{6 7 8 9 10}

How is the Health Coaching treatment for lung transplant candidates different from other treatments?

Health Coaching for lung transplant candidates is unique because it focuses on personalized support and guidance to improve physical activity and manage psychosocial stress, rather than relying on medication or traditional medical interventions. This approach is novel as it emphasizes behavioral changes and emotional support to prepare patients for transplantation. ^{7 8 11 12 13}

Research Team

Cassie C Kennedy, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

I am younger than 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. Australia 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. [2018]

2. England 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. [2019]

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

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Coaching and barriers to weight loss: an integrative review. [2022]

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

Can life coaching improve health outcomes?--A systematic review of intervention studies. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Can we HALT obesity following lung transplant? A Dietitian- and Physiotherapy-directed pilot intervention. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a physical activity behavioural modification tele-coaching intervention in lung transplant recipients. [2022]

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

A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A randomized, controlled, behavioral intervention to promote walking after abdominal organ transplantation: results from the LIFT study. [2021]

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

Physical activity in solid organ transplant recipients: organizational aspects and preliminary results of the Italian project. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Determinants of physical activity in daily life in candidates for lung transplantation. [2012]

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

Assessment and management of psychosocial stress in lung transplant candidates. Toronto Lung Transplant Group. [2019]

13. Denmark pubmed.ncbi.nlm.nih.gov

Evaluation of a hand-held, computer-based intervention to promote early self-care behaviors after lung transplant. [2021]