Skip to main content
OpenTrials
Completed

NCT Number: NCT01581008

Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

About this study

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:

  • A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes
  • evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse;
  • 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
  • brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
  • 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.

The specific aims of the study are to:

  • Examine intervention feasibility and determine preliminary estimates of intervention effect
  • Determine patient participation rates and cohort retention
  • Conduct a preliminary assessment of outcomes by measuring pre-post changes in quality of life, depressive symptoms, health status, life meaning, and spirituality.
  • Obtain qualitative feedback from study participants, the persons providing the intervention, and providers/leaders in primary care, mental health, palliative care, chaplaincy, and hospital operations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • eligible veterans from the Denver VAMC will have a prior primary discharge diagnosis of heart failure in the last year,
  • be at least 18 years of age, able to read and understand English,
  • have consistent access to a telephone
  • at least one of the following:
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60;
  • a second hospitalization for with a primary discharge diagnosis of heart failure in the last year;
  • taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks;
  • BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or
  • estimated creatinine clearance 30-80 mL/min.

Exclusion criteria

  • previous diagnosis of dementia;
  • active substance abuse, defined as an AUDIT-C score greater than 7, two positive responses on substance abuse screening questions, or medical records indicating active substance abuse or dependence;
  • comorbid metastatic cancer, given the focus on heart failure palliative care;
  • nursing home resident; and
  • diagnosis of bipolar disorder or schizophrenia.

Treatment and study plan

Collaborative Care to Alleviate Symptoms and Adjust to Illness

Other

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

Psychospiritual

Behavioral

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.

Primary outcomes

  1. Cohort Retention

    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.

Secondary outcomes

  1. Was Depression Addressed?

    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?"

  2. Participation Rates

    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.

  3. Adherence to the Study Protocol (CASA Arm Only)

    Time frame: 3 months

    The investigators will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as:

    • how often is depression addressed with a treatment plan?
    • how often are care team recommendations placed as orders in the medical record?
    • how often are orders completed?

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Iowa

Registry information

Official study title

Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A Pilot Study

Acronym: CASA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2012
Registry last updated
Aug 31, 2018

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.