Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease.

NCT06428513 | Unknown

• 1 other identifier: 9466-22-SMC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; End Stage Lung Disease

Outcome Measures

Primary Outcomes (11)

• Feasibility outcomes

  Retention of participants in the program/research. Calculated as a percentage of participants completing all visits of the intervention.

  Every quarter for one year

• Participant adherence

  Participant percentage that adhered to the intervention. Calculated as a percentage of the intervention.

  Every quarter for one year

• Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC) ratio: FEV1/FVC Ratio

  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%

  Every quarter for one year

• Total lung capacity (TLC)

  Total lung capacity (TLC), recorded in Liters (L)

  Every quarter for one year

• Diffusing capacity of the lungs for carbon monoxide (DLCO)

  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%

  Every quarter for one year

• Functional lung capacity using six-minute walk test (6MWT)

  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.

  Every six months for one year

• Oxygen saturation

  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.

  Every six months for one year

• Heart Rate

  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.

  Every six months for one year

• Physical activity variable

  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.

  Every quarter for one year

• Behavioural and nutritional evaluation

  • 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.

  Every quarter for one year

• Patient functioning and quality of life

  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.

  Every quarter for one year

Secondary Outcomes (8)

• Body mass index (BMI)

  Every quarter for one year

• Glucose control - glycated hemoglobin HbA1c

  Every quarter for one year

• Blood lipid profile

  Every quarter for one year

• Cardio-metabolic evaluation

  Every quarter for one year

• Rate of hospital service usage

  One year

Study Arms (2)

HCTP program

EXPERIMENTAL

Complete a HCTP program which includes 12 weekly one-on-one 30-minute tele-sessions through Zoom. Follow up will be for a year in total.

Behavioral: HCTP

Control

NO INTERVENTION

Control group participants do not receive the intervention but will receive HCTP after the end of the study.

Interventions

HCTP BEHAVIORAL

10 weekly 1-on-1 30-minute tele-sessions via Zoom, delivered by a certified health coach. At baseline assessment including full medical history, medications, lifestyle practices, self-reported health status, psychosocial status, and other relevant information will be taken. At the first session, participants identify their health vision and 3-month health goals. At subsequent meetings, participants review their progress towards reaching the prior week's goals and identify goals for the next week. An individualized action plan will be formulated to help each participant achieve their goals. The action plan will focus on important lifestyle practices (physical activity/exercise training, correct nutrition, weight management, tobacco cessation, and stress management. Patients can request further health care advice felt necessary for their progress, and will be referred to health care professionals in the rehabilitation hospital that provide care for lung transplantation candidates.

Also known as: Health coaching telemedicine program

HCTP program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rani Polak, PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liran Levy, MD

CONTACT

+97235302735; Liran.Levy@sheba.health.gov.il

Rani Polak, PhD

CONTACT

+97235307824; Rani.Polak@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: May 24, 2024
• Study Start: November 19, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 24, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)