Adults 18 to 99, any sex, with Heart Failure or Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Function Assessment of Chronic Illness Therapy-General (FACT-G)Primary· 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. The total score range is 0-108 with a higher score meaning greater quality of life.
Group
Value
95% CI
ADAPT Intervention
59.0
± 4.0
Enhanced Usual Care
54.0
± 4.0
General Symptom Distress Scale (GSDS)Secondary· 6 months
The General Symptom Distress Scale (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?" Minimum value 0 Maximum value 10 Higher scores mean more distress
Group
Value
95% CI
ADAPT Intervention
5.56
± 0.64
Enhanced Usual Care
6.0
± 0.64
Patient Health Questionnaire-8 (PHQ-8)Secondary· 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. Score range 0-24 points with a higher score indicating more depressive symptoms.
Group
Value
95% CI
ADAPT Intervention
10.02
± 1.43
Enhanced Usual Care
11.58
± 1.42
Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF)Secondary· 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. Score range 0-100 and higher scores indicate better health status.
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. Score range 0-6 with higher scores indicate worse health status.
Group
Value
95% CI
ADAPT Intervention
3.08
± 0.1
Enhanced Usual Care
3.21
± 0.1
Quality of Life at the End of Life (QUAL-EC)Secondary· 6 months
The QUAL-EC is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness. Each item is rated from 1 to 5, and mean scores for multiple items in a domain, i.e., subscale were estimated. Minimum score for each subscale is 1, maximum is 5. A higher score is a better perception of quality of life for each subscale.
QUAL-E: Life Completion
Group
Value
95% CI
ADAPT Intervention
3.01
± 0.23
Enhanced Usual Care
2.88
± 0.23
QUAL-E: Relationship With Healthcare Provider
Group
Value
95% CI
ADAPT Intervention
3.05
± 0.22
Enhanced Usual Care
2.87
± 0.22
QUAL-E: Preparation
Group
Value
95% CI
ADAPT Intervention
3.86
± 0.22
Enhanced Usual Care
3.55
± 0.22
QUAL-E: Feel At Peace
Group
Value
95% CI
ADAPT Intervention
3.35
± 0.29
Enhanced Usual Care
3.18
± 0.29
Advance Care Planning Communication and DocumentationSecondary· 6 months
Advance care planning discussions and advance directive documentation in the electronic medical record will be assessed via electronic medical record review. An advance directive includes either a living will and/or durable power of attorney for health care.
Documented Advance Care Planning Discussion
Group
Value
95% CI
ADAPT Intervention
106
Enhanced Usual Care
5
Documented Advance Directive
Group
Value
95% CI
ADAPT Intervention
58
Enhanced Usual Care
62
MortalitySecondary· 12 months
The following events will be assessed during the study period through medical record review to supplement patient report: mortality.
The GAD-7 is a valid and reliable self-report measure of anxiety tested in medically ill outpatient populations. Score range 0-21 and higher scores indicate more anxiety symptoms.
Group
Value
95% CI
ADAPT Intervention
5.82
± 1.43
Enhanced Usual Care
6.92
± 1.42
Advance Care Planning EngagementSecondary· 6 months
This survey was designed to measure behaviors related to surrogate decision makers, values and quality of life, and informed decision making. Specifically, the Advance Care Planning-4 (ACP-4) measure (Sudore et al) was used.
Minimum value is 1, maximum value is 5. Higher scores indicate higher levels of readiness to engage in advance care planning.
Group
Value
95% CI
ADAPT Intervention
4.21
± 0.34
Enhanced Usual Care
3.68
± 0.34
PEG (Pain)Secondary· 6 months
The PEG measures pain intensity and interference (Krebs, 2009). Scale range 0-10 and higher score indicates more pain.
Group
Value
95% CI
ADAPT Intervention
4.76
± 0.72
Enhanced Usual Care
5.04
± 0.72
Insomnia Severity Index (ISI)Secondary· 6 months
The ISI measures insomnia severity (Bastien, 2000). There are 6 items and a mean was used. Minimum score is 0, maximum score is 4. A higher score indicates more severe insomnia.
Group
Value
95% CI
ADAPT Intervention
2.11
± 0.26
Enhanced Usual Care
2.26
± 0.26
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event reporting is reported from the time participants were randomized until 6-months (for hospitalizations and all other adverse events) and 12-months (for mortality)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (i.e., pulmonary fibrosis) are common serious illnesses. Despite disease-specific medical care, people with these illnesses often left with poor quality of life (i.e., burdensome symptoms, impaired function). Furthermore, while these illnesses are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning, the process of considering and communicating healthcare values and goals. The investigators are conducting a randomized clinical trial to study a symptom management, psychosocial care and advance care planning intervention to improve quality of life. The study is important because it aims to improve quality of life and provision of care according to peoples' goals and preferences in common, burdensome illnesses. Furthermore, this study will generate information that supports the broader dissemination and implementation of the intervention and informs the development of future palliative care and team-based interventions in the VA.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07531966 — Vascular Complications After Kidney Transplantation
· recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
· Phase 1
· not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran
· NA
· not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness
· NA
· not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
· NA
· not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 9 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02713347.