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出境医 / 临床实验 / Development of BREATHE-ALD, a Shared Decision-Making Intervention for Adults With Advanced Lung Disease (BREATHE-ALD)

Development of BREATHE-ALD, a Shared Decision-Making Intervention for Adults With Advanced Lung Disease (BREATHE-ALD)

Study Description
Brief Summary:
Interviews and surveys with 10 patients with advanced lung disease and 10 caregivers

Condition or disease
Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial

Detailed Description:

After obtaining informed consent from patient participants, the research team will collect demographic and diagnosis information, administer surveys and conduct interviews.

Surveys

The research team will collect demographic information (two forms) and administer questionnaires to characterize the participants.These include:

Chronic obstructive pulmonary disease (COPD) Assessment Test modified Medical Research Council dyspnea scale Short Form-36 (SF-36) St. George's Respiratory Questionnaire Biomedical Research Informatics Computing System (BRICS) National institute of Nursing Research (NINR) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 6a BRICS NINR PROMIS SF v.1.0- Pain Intensity 3a Charleson Comorbidity Index Newest Vital Sign Short Assessment of Health Literacy -English Interviews The research team will collect qualitative data from the interviews using a semi-structured iterative interview guide.

After obtaining informed consent from informal caregiver participants, we will collect demographic information about their loved one (two forms), administer surveys and conduct interviews. Surveys

These include:

Charleson Comorbidity Index Newest Vital Sign Short Assessment of Health Literacy -English Interviews The research team will collect qualitative data from the interviews using a semi-structured iterative interview guide.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Development and Pilot Testing of a Brief Shared Decision-Making Intervention to Improve Palliative Care Outcomes for Adults With Advanced Lung Disease
Actual Study Start Date : November 10, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Number of qualitative interviews completed [ Time Frame: Visit 1 (60 minutes) ]
    This observational study is designed to collect information using semi-structured in-depth individual interviews with adults with advanced lung disease and caregivers of adults with advanced lung disease.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients and caregivers of patients followed for ALD at Weill Cornell Medicine.
Criteria

Inclusion Criteria:

  • Adults with symptomatic advanced lung disease (ALD) followed at Weill Cornell Medicine (WCM )
  • Caregivers of adults with symptomatic ALD followed at Weill Cornell Medicine

Exclusion Criteria:

  • Serious mental health conditions that preclude completion of study procedures or confound analyses
  • Individuals who are anticipated to have less than 3-month survival.
Contacts and Locations

Contacts
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Contact: Katherine T South, BSN 413-519-3142 kts2133@cumc.columbia.edu

Locations
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United States, New York
CUIMC Recruiting
New York, New York, United States, 10032
Contact: Katherine South, BSN    413-519-3142    kts2133@cumc.columbia.edu   
Principal Investigator: Maureen George, PhD         
Sponsors and Collaborators
Columbia University
Weill Medical College of Cornell University
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Maureen George, PhD Columbia University
Tracking Information
First Submitted Date June 11, 2021
First Posted Date June 18, 2021
Last Update Posted Date December 7, 2021
Actual Study Start Date November 10, 2021
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2021) 		Number of qualitative interviews completed [ Time Frame: Visit 1 (60 minutes) ]
This observational study is designed to collect information using semi-structured in-depth individual interviews with adults with advanced lung disease and caregivers of adults with advanced lung disease.
Original Primary Outcome Measures
 (submitted: June 11, 2021) 		Qualitative interviews [ Time Frame: a single 60 minute interview ]
semi-structured in-depth individual interviews with adults with advanced lung disease and caregivers of adults with advanced lung disease
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of BREATHE-ALD, a Shared Decision-Making Intervention for Adults With Advanced Lung Disease
Official Title The Development and Pilot Testing of a Brief Shared Decision-Making Intervention to Improve Palliative Care Outcomes for Adults With Advanced Lung Disease
Brief Summary Interviews and surveys with 10 patients with advanced lung disease and 10 caregivers
Detailed Description

After obtaining informed consent from patient participants, the research team will collect demographic and diagnosis information, administer surveys and conduct interviews.

Surveys

The research team will collect demographic information (two forms) and administer questionnaires to characterize the participants.These include:

Chronic obstructive pulmonary disease (COPD) Assessment Test modified Medical Research Council dyspnea scale Short Form-36 (SF-36) St. George's Respiratory Questionnaire Biomedical Research Informatics Computing System (BRICS) National institute of Nursing Research (NINR) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 6a BRICS NINR PROMIS SF v.1.0- Pain Intensity 3a Charleson Comorbidity Index Newest Vital Sign Short Assessment of Health Literacy -English Interviews The research team will collect qualitative data from the interviews using a semi-structured iterative interview guide.

After obtaining informed consent from informal caregiver participants, we will collect demographic information about their loved one (two forms), administer surveys and conduct interviews. Surveys

These include:

Charleson Comorbidity Index Newest Vital Sign Short Assessment of Health Literacy -English Interviews The research team will collect qualitative data from the interviews using a semi-structured iterative interview guide.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients and caregivers of patients followed for ALD at Weill Cornell Medicine.
Condition
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases, Interstitial
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 11, 2021) 		20
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults with symptomatic advanced lung disease (ALD) followed at Weill Cornell Medicine (WCM )
  • Caregivers of adults with symptomatic ALD followed at Weill Cornell Medicine

Exclusion Criteria:

  • Serious mental health conditions that preclude completion of study procedures or confound analyses
  • Individuals who are anticipated to have less than 3-month survival.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Katherine T South, BSN 413-519-3142 kts2133@cumc.columbia.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04930666
Other Study ID Numbers AAAT2217
P20NR018072 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Maureen George, Columbia University
Study Sponsor Columbia University
Collaborators
  • Weill Medical College of Cornell University
  • National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Maureen George, PhD Columbia University
PRS Account Columbia University
Verification Date December 2021