Post-Lung Transplantation Clinical Trial
— INSPIRE-IIIOfficial title:
Improving Lung Transplant Outcomes With Coping Skills and Physical Activity
Verified date | March 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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 | |
Primary | 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 | 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 |