Depression Clinical Trial
Official title:
The Impact of Palliative Care on Quality of Life, Anxiety, and Depression in Patients With Idiopathic Pulmonary Fibrosis
Verified date | January 2020 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the effects of adding a palliative care intervention
for patients with idiopathic pulmonary fibrosis (IPF) to current standard of care.
Palliative care is comprehensive, coordinated interdisciplinary care for patients and
families facing a potentially life-threatening illness. This consists of specially trained
teams of professionals including physicians, nurses, social workers, and chaplains that
provide care and support in inpatient and outpatient settings. While the specific assistance
and support provided by the Palliative Care Service depends on individual patient and family
needs and preferences, it may include:
1. Pain and symptom management
2. Psychosocial and spiritual support
3. Assistance with treatment choices
4. Help in planning for care in the community
Status | Completed |
Enrollment | 22 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - IPF as diagnosed by chest CT or lung biopsy, and documented by a pulmonologist in the patient's medical record - Capacity to provide informed consent Exclusion Criteria: - Documented malignancy that would impact mortality within the study enrollment period - Inability to pay for palliative care visit, insurance or personally. |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline respiratory quality of life as measured by SGRQ | The Saint George's Respiratory Questionnaire (SGRQ) is 50-item survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life. | 6 months | |
Primary | Change from baseline anxiety and depression symptoms as measured by HADS | The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety. | 6 months | |
Primary | Change in prevalence of baseline depression as measured by PHQ-9 | The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression. | 6 months | |
Secondary | Change from baseline of spirometry | Spirometry is a commonly-used pulmonary function test (PFT) measuring lung function. Greater spirometry output will be considered a measure of greater treatment efficacy. | 6 months | |
Secondary | Change from baseline of diffusing capacity | Diffusing capacity is a commonly-used pulmonary function test (PFT) measuring the transfer of gas from air in the lung to the red blood cells in lung blood vessels. Greater diffusing capacity will be considered a measure of greater treatment efficacy. | 6 months | |
Secondary | Change from baseline of lung volume | Lung volume is a commonly-used pulmonary function test (PFT) measuring the volume of inhaled or exhaled air. Greater lung volume will be considered a measure of greater treatment efficacy. | 6 months | |
Secondary | Change from baseline of 6-minute walk distance | 6-minute walk distance will be considered as a measure of invention efficacy, with an increase in 6-minute walk distance considered a measure of greater treatment efficacy. | 6 months | |
Secondary | Total number of hospitalizations due to any cause | Total number of hospitalizations due to any cause will be considered as a measure of intervention efficacy, with decrease hospitalizations in the treatment group considered a measure of greater treatment efficacy. | 6 months | |
Secondary | All-cause mortality | All-cause mortality will be considered as a measure of intervention efficacy, with decrease in mortality in the treatment group considered a measure of greater treatment efficacy. | 6 months |
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