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

NCT04930666 | Completed

• 2 other identifiers: AAAT2217P20NR018072
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to:

1. 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. 2.To evaluate the feasibility and acceptability of intervention procedures; and
3. 3.To explore intervention effects on ALD outcomes

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Keywords

Lung Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 6 months

• 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.

  Up to 3 months post-intervention

• 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).

  Up to 3 months post-intervention

Secondary Outcomes (5)

• Mean St. George's Respiratory Questionnaire

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

• Mean PROMIS Pain Intensity - Short Form V10 3a

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

• Mean PROMIS Fatigue - Short Form 6a

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

• Mean Short Form 36

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

• Mean Shared Decision Making Questionnaire

  Baseline (immediately post-intervention)

Interventions

BRief intervention to Enhance Adherence to Treatment and HEalth advice in Advanced Lung Disease OTHER

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).

Also known as: BREATHE-ALD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Weill Medical College of Cornell University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maureen George, PhD

  Columbia University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing at CUIMC

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: November 10, 2021
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

US (1)