VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220, United States
NCT Number: NCT01581008
The overall goal of this study is to evaluate the pilot implementation of two palliative care interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Denver, Colorado, 80220, United States
The investigators will examine the feasibility of two palliative care interventions designed to improve different facets of quality of life. Briefly, the two interventions are:
The specific aims of the study are to:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
Other names: Palliative symptom management and psychosocial care
A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
Time frame: 3 months
Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study.
Time frame: 3 months
The Patient Health Questionnaire-9 (PHQ-9) rates nine DSM-IV criteria of depression on a 0 (not at all) to 3 (nearly every day) scale. Scale range is 0-27, with depression severity scored: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-27 (severe). The suicidal item is "thoughts that you would be better off dead, or of hurting yourself in some way?"
Time frame: 7 months
The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.
Time frame: 3 months
The investigators will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as:
VA Office of Research and Development
Fed
Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A Pilot Study
Acronym: CASA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06248658
Cardiovascular Diseases, Chronic Heart Failure (CHF)
Moscow, Russia
View Trial DetailsNCT02884206
Cardiovascular Diseases, Chronic Heart Failure (CHF)
Andalusia, Alabama, United States
View Trial DetailsNCT02807857
Cardiovascular Diseases, Chronic Heart Failure (CHF)
Kluisbergen, Belgium
View Trial DetailsNCT01546532
Cardiovascular Diseases, Chronic Heart Failure (CHF)
Baltimore, Maryland, United States
View Trial Details