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Completed

NCT Number: NCT01739686

Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial

Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. The investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years of age or older
  • Able to read and understand English
  • Consistent access to a telephone
  • Patients have a primary care or other provider who is willing to facilitate intervention medical recommendations
  • A diagnosis of heart failure with at least one of the following:

[hospitalization primarily for heart failure in the year prior (including current); taking at least 20 mg oral furosemide (or equivalent) daily in a single or divided dose; Brain natriuretic peptide(BNP) ≥ 100 or N-terminal prohormone of brain natriuretic peptide(NT-proBNP) ≥ 500; EF≤40%]

  • Report a low health status (KCCQ-SF≤70)
  • Bothered by at least one target symptom:

[Pain; Depression; Fatigue; Breathlessness]

Exclusion criteria

  • Previous diagnosis of dementia
  • Active substance abuse or dependence, defined by either a diagnosis of abuse or dependence or an AUDIT-C ≥ 8, or self-reported substance abuse in the past 3 months
  • Comorbid metastatic cancer
  • Nursing home resident
  • Heart Transplant recipient
  • LVAD recipient

Treatment and study plan

CASA Intervention

Other

CASA Intervention

The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components:

A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression.

A social worker provides structured counseling targeting adjustment to illness and depression if present.

A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker.

Most of the nurse and social worker visits are by phone.

Primary outcomes

  1. Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score

    Time frame: 6 months

    The KCCQ is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The study will test whether there is a difference in KCCQ overall score between the intervention and control groups at 6 months.

Secondary outcomes

  1. Difference in Patient Health Questionnaire-9 (PHQ-9) score

    Time frame: 6 months

    The PHQ-9 is a 9-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-9 was developed in medically-ill outpatients, including patients with heart failure.

  2. Difference in symptom distress, measured using the General Symptom Distress Scale

    Time frame: 6 months

    The General Symptom Distress Scale (GSDS)includes a measure of overall symptom distress and ability to manage symptoms.

  3. Difference in Self-care of Heart Failure Index (SCHFI)

    Time frame: 12 months

    The SCHFI is a valid and reliable 22-item self-report measure of self-care that includes three self-care scales: maintenance, management, and confidence

  4. Difference in Satisfaction with Healthcare

    Time frame: 6 months

  5. Difference in pain using the PEG

    Time frame: 6 months

    The PEG items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G).

  6. Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure

    Time frame: 6 months

  7. Change in Dyspnea

    Time frame: 6 months

    PEG pain measure modified to assess breathlessness

  8. Change in Sheehan Disability Scale

    Time frame: 12 months

    Measure of functioning

  9. Change in Quality of Life at the End of Life (QUAL-E)

    Time frame: 12 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. We will use the relationship with health care system, preparation, life completion, and global quality of life sub-scales.

Sponsors and collaborators

Lead sponsor

Denver Research Institute

Other

Collaborators

  • Denver Health Medical Center
  • University of Colorado, Denver
  • University of Iowa
  • VA Eastern Colorado Health Care System

Registry information

Acronym: CASA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2012
Registry last updated
Aug 1, 2017

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.

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