SHEBA-9466-22-RP-CTIL Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC) ratio: FEV1/FVC Ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with end stage lung disease assessed suitable for lung transplantation.
- •Able and willing to watch online instructional videos.
排除标准
- •Unwilling or unable to provide consent
- •Uncooperative or combative
- •Unable to use / connect to video conferencing
结局指标
主要结局
Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC) ratio: FEV1/FVC Ratio
时间窗: Every quarter for one year
FEV1/FVC ratio expressed as a percentage. The lower the percentage, the more severe the lung condition. Predictive (normal) values are equal to or greater than 70%. Abnormal values are graded: Mild: 60-69% Moderate: 50-59% Severe: Under 50%
Feasibility outcomes
时间窗: Every quarter for one year
Retention of participants in the program/research. Calculated as a percentage of participants completing all visits of the intervention.
Participant adherence
时间窗: Every quarter for one year
Participant percentage that adhered to the intervention. Calculated as a percentage of the intervention.
Total lung capacity (TLC)
时间窗: Every quarter for one year
Total lung capacity (TLC), recorded in Liters (L)
Diffusing capacity of the lungs for carbon monoxide (DLCO)
时间窗: Every quarter for one year
Changes in DLCO test from the baseline used to determine progression or regression of disease. DLCO (also known as Transfer factor for carbon monoxide (TLCO)) Units ml/min/mmHg/L. Initial and final Carbon monoxide (CO) concentration, in mmol CO, and breath-holding time in minutes, are used to calculate DLCO Severity and classification of DLCO reduction: Normal DLCO: \>75% of predicted, up to 140% Mild: 60% to LLN (lower limit of normal) Moderate: 40% to 60% Severe: \<40%
Functional lung capacity using six-minute walk test (6MWT)
时间窗: Every six months for one year
To assess a patient's functional status / to track functional change resulting from disease progression or therapeutic intervention. The higher a patient's score, the better their lung capacity. A low score correlates with lower function. Calculation measurements: weight in kilograms, height in centimetres, age of patient in years, distance walked meters. Calculation MEN: 6MWD = (7.57 × height) - (5.02 × age) - (1.76 × weight) - 309 WOMEN: 6MWD = (2.11 × height) - (2.29 × weight) - (5.78 × age) + 667 Heart rate and oxygen saturation will also be measured separately but included to provide an assessment of functional status.
Heart Rate
时间窗: Every six months for one year
Heart Rate measured as a beats per minute. Taken at rest and breathing room air, and during taken during exercise test. This is used as part of Functional lung capacity using six-minute walk test (6MWT) to assess functional capacity.
Oxygen saturation
时间窗: Every six months for one year
Oxygen saturation, measured as a percentage. Taken at rest and breathing room air, and during taken during exercise test. This is used as part of Functional lung capacity using six-minute walk test (6MWT) to assess functional capacity.
Physical activity variable
时间窗: Every quarter for one year
Physical activity will be measured by the international physical activity questionnaire. A change in physical activity Scoring a HIGH level of physical activity on the IPAQ means the participant's physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level. Scoring a MODERATE level of physical activity on the IPAQ means the participant is doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days. Scoring a LOW level of physical activity on the IPAQ means that the participant is not meeting any of the criteria for either MODERATE of HIGH levels of physical activity.
Behavioural and nutritional evaluation
时间窗: Every quarter for one year
• Health behaviours: Nutritional intake will be evaluated by a 4-day food record in which subjects document and report their food consumption. Intake will be analyzed for its caloric content, nutritional values and group classifications and its Mediterranean index.
Patient functioning and quality of life
时间窗: Every quarter for one year
Evaluated using the St. George's respiratory questionnaire. Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.Scores range from 0 to 100, with higher scores indicating more limitations.
次要结局
- Glucose control - glycated hemoglobin HbA1c(Every quarter for one year)
- Body mass index (BMI)(Every quarter for one year)
- Blood lipid profile(Every quarter for one year)
- Cardio-metabolic evaluation(Every quarter for one year)
- Participant evaluation(Month 6)
- Rate of hospital service usage(One year)
- Participant perception of the program(Month 0)
- Behavioural and psychosocial outcome(Month 3)