Improving Lung Transplant Outcomes With Coping Skills and Physical Activity

Post-Lung Transplantation Clinical Trial

— INSPIRE-III  

Official title:

Improving Lung Transplant Outcomes With Coping Skills and Physical Activity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04093869
• Other study ID #: Pro00100300
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post-Lung Transplantation

Intervention

Behavioral:
• Coping Skills Training combined with Exercise (CSTEX)
The CSTEX condition has two integrated components: the CST component will systematically train patients in the use of coping skills for stress reduction and promote key transplant-specific health behaviors. The exercise component of the intervention will progressively increase participants exercise and promote daily physical activity through motivational interviewing strategies.
• Standard of Care plus Education (SOC-ED)
The SOC-ED condition provides support and enhanced post-transplant education. Participants will be given detailed educational information about post-transplant care, the importance of medication adherence, and maintenance of physical activity.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Global Psychological Distress	A composite distress score will assess change from baseline to 12 weeks (post-intervention) and combine the following instruments: General Health Questionnaire, Perceived Stress Scale, Beck Depression Inventory-II, State Trait Anxiety Inventory, and PROMIS Anger	Baseline; 12 weeks
Secondary	Changes in Functional Capacity	Functional capacity will be measured by distance walked on a standard Six Minute Walk Test (6MWT) at baseline and again post-intervention at 12 weeks.	Baseline; 12 weeks
Secondary	Changes in Physical Activity	Daily physical activity will be assessed via a wrist-worn activity monitor (Actigraph GT9X Link) for 7 consecutive days at baseline and again post-intervention at 12 weeks.	Baseline; 12 weeks
Secondary	Changes in Sleep Quality	Sleep quality will be assessed via the Pittsburgh Sleep Quality Index at baseline and again post-intervention at 12 weeks.	Baseline; 12 weeks
Secondary	Changes in Quality of Life	Quality of Life will be assessed via the Lung Transplant Quality of Life Survey, which is comprised of 10 scales that measure symptoms, health perceptions, functioning, and well being at baseline and again post-intervention at 12 weeks.	Baseline; 12 weeks
Secondary	Changes in Frailty	Frailty will be measured by performance on the Fried Frailty Index. This assessment includes measures on patient's weight, exhaustion level, physical activity, walking speed, and hand grip strength at baseline and again post-intervention at 12 weeks. Scores are based on the participants performance with lower scores indicating less frailty.	Baseline; 12 weeks
Secondary	Changes in Coping	Coping will be assessed via the Brief COPE Inventory, which is composed of scales that measure problem-focused coping, emotion-focused coping, and avoidant coping responses at baseline and again post-intervention at 12 weeks. Items are scored on a 4-point Likert scale, with 1 indicating a coping mechanism that the participant has not been doing at all, to 4 indicating a coping mechanism in which the participant has been doing a lot. A higher score within the problem-focused and emotion-focused coping subscales indicate better coping strategies, a lower score within the avoidant coping subscale indicates a more useful coping strategy.	Baseline; 12 weeks
Secondary	Changes in Self-Efficacy	Self-efficacy will be assessed via the General Self-Efficacy Scale, which is a 10-item scale that measures emotional distress at baseline and again post-intervention at 12 weeks. Scores range from 10-40 with a higher score indicating better self-efficacy.	Baseline; 12 weeks
Secondary	Clinical Outcomes	The main clinical/medical endpoint will be a measure of chronic lung allograft dysfunction (CLAD) free survival.	Up to 3 years post-treatment