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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04093869
Other study ID # Pro00100300
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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