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| ID | Type | Description | Link |
|---|---|---|---|
| P20NR018072 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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This study aims to:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Pre-trial
Inclusion Criteria:
Exclusion Criteria:
Trial
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Patients and caregivers of patients followed for advanced lung disease at Weill Cornell Medicine. Nurse practitioner who manages ALD patients at Weill Cornell Medicine.
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| Name | Affiliation | Role |
|---|---|---|
| Maureen George, PhD | Columbia University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
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| Baseline, 1 month, 2 months, and 3 months (post-intervention) |
| 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). | Baseline, 1 month, 2 months, and 3 months (post-intervention) |
| 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). | Baseline, 1 month, 2 months, and 3 months (post-intervention) |
| 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 | Baseline, 1 month, 2 months, and 3 months (post-intervention) |
| 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". | Baseline (immediately post-intervention) |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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