NCT01581008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 11, 2014

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

October 31, 2011

Results QC Date

November 3, 2014

Last Update Submit

August 1, 2018

Conditions

Chronic Heart Failure (CHF)

Keywords

palliative careheart failuredelivery of health care

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (3)

  • Was Depression Addressed?

    3 months

  • Participation Rates

    7 months

  • Adherence to the Study Protocol (CASA Arm Only)

    3 months

Study Arms (2)

Collaborative Care to Alleviate Symptoms and Adjust to Illness

EXPERIMENTAL

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: Collaborative Care to Alleviate Symptoms and Adjust to Illness

Psychospiritual

ACTIVE COMPARATOR

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.

Behavioral: Psychospiritual

Interventions

Collaborative Care to Alleviate Symptoms and Adjust to IllnessOTHER

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.

Also known as: Palliative symptom management and psychosocial care
Collaborative Care to Alleviate Symptoms and Adjust to Illness
PsychospiritualBEHAVIORAL

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.

Psychospiritual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

Related Publications (2)

  • 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.

    PMID: 24329424RESULT

  • 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.

    PMID: 27076391RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
David Bekelman, MD, MPH
Organization
VA Eastern Colorado Health Care System
david.bekelman@va.gov
720-857-5088

Study Officials

  • David Bekelman, MD MPH

    VA Eastern Colorado Health Care System, Denver, CO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2011

First Posted

April 19, 2012

Study Start

October 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

August 31, 2018

Results First Posted

November 11, 2014

Record last verified: 2018-08

Locations

US(1)