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

NCT ID: NCT01581008

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-12-31

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.

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

1. evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse;

2. 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

3. brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.

2. 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

1. Determine patient participation rates and cohort retention

2. Conduct a preliminary assessment of outcomes by measuring pre-post changes in quality of life, depressive symptoms, health status, life meaning, and spirituality.

2. 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.

Conditions

Chronic Heart Failure (CHF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Collaborative Care to Alleviate Symptoms and Adjust to Illness

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.

Group Type: EXPERIMENTAL

Collaborative Care to Alleviate Symptoms and Adjust to Illness

Intervention Type: 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.

Psychospiritual

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.

Group Type: ACTIVE_COMPARATOR

Psychospiritual

Intervention Type: 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.

Interventions

Collaborative Care to Alleviate Symptoms and Adjust to Illness

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.

Intervention Type: OTHER

Psychospiritual

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Palliative symptom management and psychosocial care

Eligibility Criteria

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:

1. Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60;

2. a second hospitalization for with a primary discharge diagnosis of heart failure in the last year;

3. taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks;

4. BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or

5. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Bekelman, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Eastern Colorado Health Care System, Denver, CO

Locations

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24329424 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27076391 (View on PubMed)

Other Identifiers

CRICC Pilot

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RRP 11-239

Identifier Type: -

Identifier Source: org_study_id