Improving Lung Transplant Outcomes With Coping Skills and Physical Activity (INSPIRE-III)
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|ClinicalTrials.gov Identifier: NCT04093869|
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : March 31, 2022
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: James A Blumenthal, PhDemail@example.com|
|Contact: Scott Palmer, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: James A Blumenthal, PhD 919-684-3828 email@example.com|