Clinical trial NCT06428513: Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease.
Official title: SHEBA-9466-22-RP-CTIL Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Copd
End Stage Lung Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-05-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lung transplantation has become standard of care for selected patients with end stage pulmonary disease. While on the lung transplantation waiting list, patient health, emotional wellbeing and quality of life can deteriorate. By improving or changing patient physical activity, healthy nutrition, tobacco cessation, patient preparation for lung transplantation can be optimized, risk of complications can be reduced, and outcomes post transplantation can be improved.

The potential of health coaching to improve health outcomes has been demonstrated in several chronic diseases such as type 2 diabetes mellitus, congestive heart failure, and rheumatoid arthritis. In addition, health coaching was proven effective through telemedicine.

No studies so far have addressed the potential effect of a pre-transplant health coaching program on existing medical conditions, transplant rates and post-transplant outcomes. Investigators hypothesized that health coaching can improve health outcomes and survival of lung transplantation candidates by supporting and growing patients' capacity to cope with the demands of their end stage pulmonary disease.

Detailed description: SCIENTIFIC BACKGROUND Lung transplantation has become an established standard of care for selected patients with end stage pulmonary disease. Candidate selection begins with a referral from the non-transplant pulmonologist and if deemed suitable, begins an evaluation process that determines eligibility for transplantation. Candidates who meet all requirements are listed for transplantation. While on the waiting list, physical activity, healthy nutrition, tobacco cessation, and a few other health behaviors are essential to maintain candidacy. In addition to the physical limitations imposed by end-stage lung disease, transplant candidates face a range of psychosocial issues relating to changes in functional capacity, including social roles, relationships, perceptions of self, and life plans and goals. Efforts targeted at these domains may improve quality of life, optimize patient preparation for transplantation, reduce the risk of complications, and improve outcomes.

Health coaching has emerged as a widely adopted intervention that may help individuals with chronic conditions adopting health behaviors that improve quality of life, health, and emotional wellbeing. It is a patient-centered approach wherein the individual and coach work together through active health education processes and motivational interviewing to set goals that improve health outcomes. The potential of health coaching to improve health outcomes has been demonstrated in several chronic diseases such as type 2 diabetes mellitus, congestive heart failure, and rheumatoid arthritis. In addition, health coaching was proven effective through telemedicine; and recently, it has developed national standards and accreditations in the US. Therefore, health coaching was selected as our telemedicine approach, and a novel health coaching telemedicine program (HCTP) was developed at Sheba Medical Center for lung transplantation candidate.

No studies so far have addressed the potential effect of pre-transplant health coaching program on existing medical conditions, transplant rates and post-transplant outcomes. Investigators hypothesized that health coaching can improve health outcomes and survival of lung transplantation candidates by supporting and growing patients' capacity to cope with the demands of their end stage pulmonary disease.

SPECIFIC AIMS Specific Aim 1: To assess whether HCTP is feasible among participants with end stage lung disease who are candidate for lung transplantation.

Specific Aim 2: To collect data on the impact of a HCTP on health-related quality of life, lung functions, functional capacity, cardiometabolic parameters (e.g., weight, lipid profile, fasting glucose), and hospital services utilization of participants with end stage lung disease who are candidate for lung transplantation Specific Aim 3: To collect data on experience and capacity to cope with the demands of the illness of participants with end stage lung disease who are candidate for lung transplantation.

STUDY DESIGN Detailed Plan of the Study The health coaching tele-medicine program study is a randomized controlled feasibility trial in which study participants are randomly assigned into either a study group or a control group.

Source of participants and recruitment methods: This study is a collaboration between the lung transplant program and the center of lifestyle medicine, within Sheba's cardiometabolic prevention center, a unique center in Israeli health care services that promote innovative lifestyle interventions. Our target population is 56 adults with end stage lung disease who refer to The Sheba Medical Center lung transplantation program for evaluation; over a period of 12 months.

METHODS:

This study is expected to be ongoing for 24 months but conducted for each subject in a 12-month timeframe. Data collection time points every quarter for 12 months.

Assessment include:

* Health related quality of life (HRQL)
* Lung functions tests
* Hospital services usage: will be evaluate using the hospital medical record. These services include health professional services in the rehabilitation hospital.
* Health behaviors: Nutritional intake will be evaluated by a 4-day food record.
* Physical activity questionnaire.
* Cardiometabolic outcomes
* Qualitative data: Investigators also expect to deepen our understanding about participants' experience in the program and their capacity to cope with the demands of their illness through the study's qualitative component. Qualitative data will be included in analyses for both participants who completed the intervention and participants who dropout.

Information regarding demographics, medications, other health behaviors (e.g., smoking status, physical activity status), and use of other nutritional education resources during the program (e.g., dietitian and physician visits, apps) will be extracted from the medical record.

PROCEDURE INTERVENTION: Both the intervention and control groups will receive the standard care for lung transplantation candidates. In addition for:

Study group participants - study group participants will complete a HCTP program which includes 12 weekly one-on-one 30-minute tele-sessions through Zoom, delivered by a credential health coach (health care professional who also completed a health coaching certification). Prior to the beginning of the program participant will complete intake assessment that will include past and current medical history, medications, current lifestyle practices, self-reported health status, psychosocial status, and other relevant information. At the first session, participants identify their health vision and 3-month health goals. During each subsequent meeting, participants will review their progress towards reaching the prior week's goals and identify goals for the coming week, using a self-discovery process facilitated by the health coach. Based on the initial assessment individualized action plan will be formulated to help each participant achieve his/her goals. The action plan will focus on important lifestyle practices (especially physical activity/exercise training, correct nutrition, weight management, tobacco cessation, and stress management. Based on their interaction with the participant and/or input from the participant's physician or other health care providers, health coaches will revise goals and action plans. When patients detect the need for health care advice that is necessary for their progress, s/he will be referred to health care professionals in the rehabilitation hospital that provide care for lung transplantation candidate.

2. Control group: Control group participants will receive HCTP after the end of the study.

Statistical methods: Patients will be randomized 1:1 between the 2 study arms. Investigators will use block randomization stratified by site. Power calculation indicates that 28 participants (14/ group) are required in each of the intervention groups in order to estimate a retention rate of 80% with 10% precision and 80% confidence. Every effort will be made to minimize dropouts, and further to follow-up with participants who do not complete the program to obtain measurements of study outcomes. In the event of missing data, the impact will be assessed and addressed, if necessary, according to current best practices. Demographic and other baseline characteristics as well as feasibility outcomes will be summarized using means and standard deviations for normally distributed variables, medians and interquartile ranges for non-normally distributed variables, and frequencies for count or dichotomous variables. For all outcomes and to address exploratory hypotheses. P-values and 95% confidence intervals will be presented for all effects of interest.

Eligibility criteria: Inclusion Criteria:

* Subjects with end stage lung disease assessed suitable for lung transplantation.
* Able and willing to watch online instructional videos.

Exclusion Criteria:

* Unwilling or unable to provide consent
* Uncooperative or combative
* Unable to use / connect to video conferencing

Primary outcomes:
measure: Feasibility outcomes
timeFrame: Every quarter for one year
measure: Participant adherence
timeFrame: Every quarter for one year
measure: Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC) ratio: FEV1/FVC Ratio
timeFrame: Every quarter for one year
measure: Total lung capacity (TLC)
timeFrame: Every quarter for one year
measure: Diffusing capacity of the lungs for carbon monoxide (DLCO)
timeFrame: Every quarter for one year
measure: Functional lung capacity using six-minute walk test (6MWT)
timeFrame: Every six months for one year
measure: Oxygen saturation
timeFrame: Every six months for one year
measure: Heart Rate
timeFrame: Every six months for one year
measure: Physical activity variable
timeFrame: Every quarter for one year
measure: Behavioural and nutritional evaluation
timeFrame: Every quarter for one year
measure: Patient functioning and quality of life
timeFrame: Every quarter for one year
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: Every quarter for one year
measure: Glucose control - glycated hemoglobin HbA1c
timeFrame: Every quarter for one year
measure: Blood lipid profile
timeFrame: Every quarter for one year
measure: Cardio-metabolic evaluation
timeFrame: Every quarter for one year
measure: Rate of hospital service usage
timeFrame: One year
measure: Participant perception of the program
timeFrame: Month 0
measure: Behavioural and psychosocial outcome
timeFrame: Month 3
measure: Participant evaluation
timeFrame: Month 6
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Rani Polak, PhD
role: PRINCIPAL_INVESTIGATOR
References: