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BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease

Study Purpose

This study aims to: 1. Develop the BREATHE-ALD intervention for adults with Advanced Lung Disease, multiple chronic conditions, and palliative care needs and their caregivers using interviews with 10 advanced lung disease (ALD) adults and their caregivers. 2. To evaluate the feasibility and acceptability of intervention procedures; and. 3. To explore intervention effects on ALD outcomes

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Pre-trial.

Inclusion Criteria:

  • - Patient participants with symptomatic advanced lung disease (ALD) followed at Weill Cornell Medicine (WCM).
  • - Caregiver participants who care for adults with symptomatic ALD followed at Weill Cornell Medicine.

Exclusion Criteria:

  • - Patients that have serious mental health conditions that preclude completion of study procedures or confound analyses.
  • - Caregivers that have serious mental health conditions that preclude completion of study procedures or confound analyses.
Trial.

Inclusion Criteria:

  • - Patient participants with symptomatic advanced lung disease (ALD) followed at Weill Cornell Medicine (WCM).
  • - Nurse practitioner must manage a panel of adult ALD patients.

Exclusion Criteria:

  • - Patients that have serious mental health conditions that preclude completion of study procedures or confound analyses.
  • - Patients anticipated to have less than 3-month survival.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04930666
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Columbia University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Maureen George, PhD
Principal Investigator Affiliation Columbia University School of Nursing
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
Additional Details

This study addresses the important problem of adults with symptomatic advanced lung disease (ALD) who are at high risk for poor outcomes. Palliative care (PCare) improves the quality of life of individuals and their caregivers through the prevention and relief of suffering by identifying, assessing and treating the physical, psychosocial and spiritual problems associated with life-threatening illness. However, pulmonary clinicians rarely refer adults with ALD to PCare because of time demands, a lack of confidence in PCare and the perceived threat PCare poses to the relationship they have established with the ALD adult. Therefore, we are developing BREATHE-ALD (BRief intervention to Enhance Adherence to Treatment and HEalth advice in Advanced Lung Disease [ALD]), a novel shared decision-making (SDM) intervention to improve outcomes for adults with ALD. The study includes two phases:

  • (1) a development phase to develop BREATHE-ALD using interviews with 10 ALD adults and their caregivers with expert review to adapt BREATHE, and (2) a pilot validation phase conducting a pilot trial in which 10 adults with ALD receive BREATHE-ALD.
We will follow adults with ALD for 3 months post-intervention to assess the impact of BREATHE-ALD on self-management and patient outcomes.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Weill Cornell Medical Center, New York, New York

Status

Recruiting

Address

Weill Cornell Medical Center

New York, New York, 10065

Site Contact

Maureen George, PhD

mg3656@cumc.columbia.edu

212-305-1175

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