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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093869
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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).

Condition or disease Intervention/treatment Phase
Post-Lung Transplantation Behavioral: Coping Skills Training combined with Exercise (CSTEX) Behavioral: Standard of Care plus Education (SOC-ED) Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Lung Transplant Outcomes With Coping Skills and Physical Activity
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Coping Skills Training combined with Exercise (CSTEX)
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.
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.

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




Primary Outcome Measures :
  1. Change in Global Psychological Distress [ Time Frame: Baseline; 12 weeks ]
    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

  2. Changes in Functional Capacity [ Time Frame: Baseline; 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Changes in Physical Activity [ Time Frame: Baseline; 12 weeks ]
    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.

  2. Changes in Sleep Quality [ Time Frame: Baseline; 12 weeks ]
    Sleep quality will be assessed via the Pittsburgh Sleep Quality Index at baseline and again post-intervention at 12 weeks.

  3. Changes in Quality of Life [ Time Frame: Baseline; 12 weeks ]
    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.

  4. Clinical Outcomes [ Time Frame: Up to 3 years post-treatment ]
    The main clinical/medical endpoint will be a measure of chronic lung allograft dysfunction (CLAD) free survival.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093869


Contacts
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Contact: James A Blumenthal, PhD 919-684-3828 james.blumenthal@duke.edu
Contact: Scott Palmer, MD 919-684-0245 scott.palmer@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: James A Blumenthal, PhD    919-684-3828    james.blumenthal@duke.edu   
Sponsors and Collaborators
Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04093869    
Other Study ID Numbers: Pro00100300
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No