Improving Lung Transplant Outcomes With Coping Skills and Physical Activity (INSPIRE-III)

Duke University

Status: Active, not recruiting

Conditions: Post-Lung Transplantation

Treatments: Behavioral: Coping Skills Training combined with Exercise (CSTEX); Behavioral: Standard of Care plus Education (SOC-ED)

Study type: Interventional

Funder types: Other

Identifiers

NCT04093869

Pro00100300

Details and patient eligibility

About

This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce distress and improve functional capacity. Half of the patients will receive CSTEX and half will receive the standard of care plus transplant education (SOC-ED).

Full description

The study will aim to evaluate the effectiveness of the CSTEX intervention in (i) reducing distress and (ii) improving functional capacity. It is hypothesized that compared to SOC-ED, the CSTEX intervention will result in 1) greater reductions in global distress measured by an established psychometric test battery; and 2) greater improvements in functional capacity assessed by distance walked on a standard Six Minute Walk test (6MWT).

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single or bilateral first lung transplant recipient; discharged from the hospital and at least 6 weeks post-transplant; completed post-transplant pulmonary rehabilitation within the past 18 months; on stable medication regimen; proficient in the English language

Exclusion criteria

• Illness such as malignancies that are associated with a life-expectancy of < 12 months; current pregnancy; inability to read or to provide informed consent; multi-organ transplant recipient or repeat lung transplant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Coping Skills Training combined with Exercise (CSTEX)

Experimental group

Description:

The CSTEX intervention will consist of 12, 30 minute weekly sessions conducted by a respiratory therapist knowledgeable about lung transplantation and trained in motivational interviewing, Cognitive Behavioral Therapy (CBT), and exercise therapy.

Treatment:

Behavioral: Coping Skills Training combined with Exercise (CSTEX)

Standard of Care plus Education (SOC-ED)

Experimental group

Description:

The SOC-ED intervention will consist of 12, 30 minute weekly sessions conducted by a health educator knowledgeable about transplantation and skilled in educational instruction.

Treatment:

Behavioral: Standard of Care plus Education (SOC-ED)