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Pulmonary Disease, Chronic ObstructiveBREATHE-ALDNCT04930666

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

An observational study of Pulmonary Disease, Chronic Obstructive and Lung Diseases, Interstitial, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
BRief intervention to Enhance Adherence to Treatment and HEalth advice in Advanced Lung Disease
How many people
30 participants
Where
1 siteUnited States
Study dates
10 Nov 2021to 6 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients and caregivers of patients followed for advanced lung disease at Weill Cornell Medicine. Nurse practitioner who manages ALD patients at Weill Cornell Medicine.

Who may be able to join

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

Who cannot join

  • 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
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medical Center

    New York, New York, 10065

Other trials in United States

About this study

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

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
Read the detailed description

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.

Being tested
BRief intervention to Enhance Adherence to Treatment and HEalth advice in Advanced Lung Disease
Keywords
Lung Disease
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BRief intervention to Enhance Adherence to Treatment and HEalth advice in Advanced Lung DiseaseOther

    Also called BREATHE-ALD

    BREATHE-ALD utilizes the patient's nurse practitioner (NP) to deliver a brief intervention using motivational interviewing and shared decision making, in a one-time 9-minute intervention. The NP will follow a 4-step script tailored to specific ALD self-management discussed during the most recent visit with the patient's pulmonologist. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of qualitative interviews completed in the development phase

    Qualitative interviews will be conducted with adults with advanced lung disease and their caregivers to understand their experiences managing ALD using semi-structured in-depth individual interviews. The information collected will aid the design of BREATHE-ALD and the implementation of the pilot phase of this study.

    Measured: Up to 6 months

  2. Ratio of participants who completed the intervention to the number of participants consented

    To determine the level of retention, the ratio of participants who completed the intervention to the number of participants consented will be measured.

    Measured: Up to 3 months post-intervention

  3. Mean mMRC (Modified Medical Research Council) Dyspnea Scale

    The mMRC (Modified Medical Research Council) Dyspnea Scale measures the effect of breathlessness when performing daily activities. The mMRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5).

    Measured: Up to 3 months post-intervention

Secondary outcomes (5)

  1. Mean St. George's Respiratory Questionnaire

    The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. It is a 50-item questionnaire with two parts, in which part one measures frequency and severity of symptoms while part two measures activities that impact breathlessness. Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: Baseline, 1 month, 2 months, and 3 months (post-intervention)

  2. Mean PROMIS Pain Intensity - Short Form V10 3a

    PROMIS Pain Intensity instrument measures how much a person hurts. It is a 3-item instrument that evaluates how much pain the patient has felt in the past seven days. Each question about pain intensity is rated on a five-point scale from had no pain (1) to very severe (5).

    Measured: Baseline, 1 month, 2 months, and 3 months (post-intervention)

  3. Mean PROMIS Fatigue - Short Form 6a

    PROMIS Fatigue instrument measures how much a person feels tired. It is a 6-10-item questionnaire that evaluates how tired or exhausted the patient has felt in the past seven days. Each question about fatigue is rated on a five-point scale from never (1) to always (5).

    Measured: Baseline, 1 month, 2 months, and 3 months (post-intervention)

  4. Mean Short Form 36

    Short Form 36 (SF-36) is a well validated instrument that measures overall health status. It consists of 36 items and has eight sections.; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability and higher scores = less disability

    Measured: Baseline, 1 month, 2 months, and 3 months (post-intervention)

  5. Mean Shared Decision Making Questionnaire

    The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from "completely disagree" to "completely agree".

    Measured: Baseline (immediately post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start10 Nov 2021
  3. Primary completion6 Feb 2025
  4. Study completion6 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04930666
Sponsor's protocol ID
AAAT2217
Other IDs
P20NR018072
Acronym
BREATHE-ALD
Status last verified
Apr 2025
First submitted
11 Jun 2021
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive and Lung Diseases, Interstitial, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of qualitative interviews completed in the development phase (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04930666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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