Advancing Symptom Alleviation With Palliative Treatment (ADAPT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02713347|
Recruitment Status : Recruiting
First Posted : March 18, 2016
Last Update Posted : August 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Pulmonary Disease, Chronic Obstructive Emphysema Pulmonary Fibrosis, Interstitial Lung Disease||Behavioral: ADAPT Intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Palliative Care to Improve Quality of Life in CHF and COPD|
|Actual Study Start Date :||September 1, 2016|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: ADAPT Intervention
The intervention includes 3 components:
The nurse and social worker visits are in-person or by phone.
Behavioral: ADAPT Intervention
The intervention includes 3 components:
No Intervention: Enhanced usual care
Patients in the control group will continue to receive care at the discretion of their providers, which may include referrals to and ongoing care from cardiology, pulmonary, palliative care, or mental health. They will also have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency. Patients' providers will be given the results of baseline depression surveys if they screen positive for depression, and patients will be given an information sheet that outlines self-care for CHF or COPD.
- Function Assessment of Chronic Illness Therapy-General (FACT-G) [ Time Frame: 6 months ]The FACT-G is a widely used, valid, reliable, and responsive self-report measure of health-related quality of life that includes domains of physical, social/family, emotional, and functional well-being. The primary outcome will be the difference in FACT-G score at 6 months.
- General Symptom Distress Scale (GSDS) [ Time Frame: 6 months ]The GSDS is a single item measure of overall symptom distress that is reliable and valid and asks, "In general, how distressing are all of your symptoms to you?"
- Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: 6 months ]The PHQ-8 is a 8-item valid and reliable instrument that provides a continuous measure of depressive symptoms and is 88% sensitive and specific for a diagnosis of major depressive disorder. The PHQ-8 was developed in medically-ill outpatients.
- Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF) [ Time Frame: 6 months ]The KCCQ-SF is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ-SF is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The KCCQ-SF will be administered to participants with heart failure.
- Clinical COPD Questionnaire (CCQ) [ Time Frame: 6 months ]The CCQ is a self-administered 10-item measure of COPD symptoms, functioning, and emotional well-being. It is well-validated, reliable, and responsive and will be administered to participants with COPD.
- Quality of Life at the End of Life (QUAL-E) [ Time Frame: 6 months ]The QUAL-E is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness.
- Advance care planning communication and documentation [ Time Frame: 6 months ]Advance care planning communication will be measured via patient self-report through the question, "At your last appointment with Dr. [Primary Care Provider] (PCP), did you discuss your treatment preferences should you become very ill?" (response items: yes, no, I don't know). Care preferences and care concurrence with preferences will be measured through two questions asking to choose a preference and then choosing the goals of current care. Advance care planning documentation (scanned advance directive (either a living will or durable power of attorney for health care); or medical orders for life-sustaining treatment) in the electronic medical record will be assessed via electronic medical record review.
- Interim events [ Time Frame: 6 months ]The following events will be assessed during the study period through medical record review to supplement patient report: hospitalization and mortality. Vital status will also be ascertained via the VA Vital Status File and the National Death Index.
- Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: 6 months ]The GAD-7 is a valid and reliable self-report measure of anxiety tested in medically ill outpatient populations.
- Advance Care Planning Engagement [ Time Frame: 6 months ]This survey was designed to measure behaviors related to surrogate decision makers, values and quality of life, and informed decision making.
- PEG (Pain) [ Time Frame: 6 months ]The PEG measures pain intensity and interference (Krebs, 2009).
- Insomnia Severity Index (ISI) [ Time Frame: 6 months ]The ISI measures insomnia severity (Bastien, 2000).
- PROMIS Fatigue [ Time Frame: 6 months ]The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity.
- K-BILD [ Time Frame: 6 months ]Quality of life measure for interstitial lung disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713347
|Contact: Marilyn Sloan, BS||(507) firstname.lastname@example.org|
|Contact: David Bekelman, MD MPH||(720) email@example.com|
|United States, Colorado|
|Rocky Mountain Regional VA Medical Center, Aurora, CO||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Sandra G Marcus, BS MHS 720-857-5110 Sandra.Marcus@va.gov|
|Contact: Kelty B Fehling, BS MPH (720) 857-5126 Kelty.Fehling@va.gov|
|Principal Investigator: David Bekelman, MD MPH|
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: David H Au, MD MS 206-277-6132 firstname.lastname@example.org|
|Sub-Investigator: David H. Au, MD MS|
|Principal Investigator:||David Bekelman, MD MPH||Rocky Mountain Regional VA Medical Center, Aurora, CO|