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Chronic Heart FailureCASANCT01739686

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

A study testing CASA Intervention in people with Chronic Heart Failure, run by Denver Research Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
CASA Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
3 sitesUnited States
Study dates
Aug 2012to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%]
Show all 9Show fewer
  • Report a low health status (KCCQ-SF≤70)
  • Bothered by at least one target symptom:
  • [Pain; Depression; Fatigue; Breathlessness]

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Denver Health

    Denver, Colorado, 80204

  • VA Eastern Colorado Health Care System(ECHCS)

    Denver, Colorado, 80220

Other trials in United States

About this study

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.

Being tested
CASA Intervention
Keywords
Quality of Life, Symptoms, Palliative care, Symptom management, Disease management, Health delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CASA InterventionOther

    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.

Study groups in NCT01739686
Study groupRoleWhat they receive
CASA InterventionExperimentalThe 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.
Receives: Other: CASA Intervention
Usual CareNo interventionPatients in the control group will continue to receive care at the discretion of their providers, which may include referral to cardiology, palliative care, or mental health. If patients self-report depression on baseline surveys, this information will be given to their provider, and patients will be given resources. Patients will have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 6 months

Secondary outcomes (9)

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

    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.

    Measured: 6 months

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

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

    Measured: 6 months

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

    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

    Measured: 12 months

  4. Difference in Satisfaction with Healthcare

    Measured: 6 months

  5. Difference in pain using the PEG

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

    Measured: 6 months

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

    Measured: 6 months

  7. Change in Dyspnea

    PEG pain measure modified to assess breathlessness

    Measured: 6 months

  8. Change in Sheehan Disability Scale

    Measure of functioning

    Measured: 12 months

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

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01739686
Sponsor's protocol ID
5R01NR013422-02
Other IDs
11-0969
Acronym
CASA
Status last verified
Jul 2017
First submitted
16 Nov 2012
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Doyon K, Flint K, Albright K, Bekelman D. Improving Benefit and Reducing Burden of Informal Caregiving for Patients With Heart Failure: A Mixed Methods Study. J Cardiovasc Nurs. 2025 Sep-Oct 01;40(5):406-412. doi: 10.1097/JCN.0000000000001137. Epub 2024 Sep 27.

    PubMed 39348302

  • Graney BA, Portz JD, Bekelman DB. "I Felt Like I Mattered": Caring is a key ingredient of collaborative care for chronic illness. Chronic Illn. 2024 Sep;20(3):383-394. doi: 10.1177/17423953241264862. Epub 2024 Jul 23.

    PubMed 39043359

  • Bekelman DB, Allen LA, McBryde CF, Hattler B, Fairclough DL, Havranek EP, Turvey C, Meek PM. Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):511-519. doi: 10.1001/jamainternmed.2017.8667.

    PubMed 29482218

  • Bekelman DB, Allen LA, Peterson J, Hattler B, Havranek EP, Fairclough DL, McBryde CF, Meek PM. Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial. Contemp Clin Trials. 2016 Nov;51:1-7. doi: 10.1016/j.cct.2016.09.002. Epub 2016 Sep 12.

    PubMed 27634669

Questions about this trial

What is this clinical trial studying?

A study testing CASA Intervention in people with Chronic Heart Failure, run by Denver Research Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01739686, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.

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