Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428513
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-11-22
Brief Title:
Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
SHEBA-9466-22-RP-CTIL Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCTP
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
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 eg 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 Shebas 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 studys 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 eg smoking status physical activity status and use of other nutritional education resources during the program eg 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 weeks 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 hisher goals The action plan will focus on important lifestyle practices especially physical activityexercise training correct nutrition weight management tobacco cessation and stress management Based on their interaction with the participant andor input from the participants 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 she 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 11 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
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 eg 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 Shebas 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 studys 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 eg smoking status physical activity status and use of other nutritional education resources during the program eg 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 weeks 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 hisher goals The action plan will focus on important lifestyle practices especially physical activityexercise training correct nutrition weight management tobacco cessation and stress management Based on their interaction with the participant andor input from the participants 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 she 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None