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Chronic Heart Failure (CHF)CASANCT01581008

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

A study testing Collaborative Care to Alleviate Symptoms and Adjust to Illness and Psychospiritual in people with Chronic Heart Failure (CHF), run by VA Office of Research and Development at 1 site 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure (CHF)
What is being tested?
Collaborative Care to Alleviate Symptoms and Adjust to Illness and Psychospiritual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
Oct 2011to Dec 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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;
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Eastern Colorado Health Care System, Denver, CO

    Denver, Colorado, 80220

Other trials in United States

About this study

Official title: Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A 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.

Read the detailed description

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:

  1. A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes
  2. evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse;
  3. 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
  4. brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
  5. 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:

  1. Examine intervention feasibility and determine preliminary estimates of intervention effect
  2. Determine patient participation rates and cohort retention
  3. Conduct a preliminary assessment of outcomes by measuring pre-post changes in quality of life, depressive symptoms, health status, life meaning, and spirituality.
  4. 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.
Being tested
Collaborative Care to Alleviate Symptoms and Adjust to Illness, Psychospiritual
Keywords
palliative care, heart failure, delivery of health care
Medical subject headings
Heart Failure

What participants receive

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

  • Collaborative Care to Alleviate Symptoms and Adjust to IllnessOther

    Also called Palliative symptom management and psychosocial care

    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.

  • PsychospiritualBehavioural

    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.

Study groups in NCT01581008
Study groupRoleWhat they receive
Collaborative Care to Alleviate Symptoms and Adjust to IllnessExperimentalA 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.
Receives: Other: Collaborative Care to Alleviate Symptoms and Adjust to Illness
PsychospiritualActive comparatorA 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.
Receives: Behavioral: Psychospiritual

What is being measured

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

  1. Cohort Retention

    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.

    Measured: 3 months

Secondary outcomes (3)

  1. Was Depression Addressed?

    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?"

    Measured: 3 months

  2. Participation Rates

    The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.

    Measured: 7 months

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

    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?

    Measured: 3 months

Timeline

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

  1. First posted19 Apr 2012 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2012
  4. Study completionDec 2012

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581008
Sponsor's protocol ID
RRP 11-239
Other IDs
CRICC Pilot
Acronym
CASA
Status last verified
Aug 2018
First submitted
31 Oct 2011
Last updated
31 Aug 2018
Data monitoring committee
No

Publications

  • Bekelman DB, Hooker S, Nowels CT, Main DS, Meek P, McBryde C, Hattler B, Lorenz KA, Heidenreich PA. Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial. J Palliat Med. 2014 Feb;17(2):145-51. doi: 10.1089/jpm.2013.0143. Epub 2013 Dec 11.

    PubMed 24329424

  • Hooker SA, Ross K, Masters KS, Park CL, Hale AE, Allen LA, Bekelman DB. Denver Spirited Heart: Mixed-Methods Pilot Study of a Psychospiritual Intervention for Heart Failure Patients. J Cardiovasc Nurs. 2017 May/Jun;32(3):226-235. doi: 10.1097/JCN.0000000000000337.

    PubMed 27076391

Questions about this trial

What is this clinical trial studying?

A study testing Collaborative Care to Alleviate Symptoms and Adjust to Illness and Psychospiritual in people with Chronic Heart Failure (CHF), run by VA Office of Research and Development at 1 site 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 5 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 11 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cohort Retention (time frame: 3 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 NCT01581008, which also lists 2 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 31 Aug 2018.

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