Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01672294
First received: May 11, 2012
Last updated: July 8, 2016
Last verified: July 2016
  Purpose

Informal caregivers provide a majority of care for patients at the end of life. Lack of end of life preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care.

This study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use


Condition Intervention
Heart Failure
Pulmonary Disease
Cancer
Other: Preparation and life completion
Other: Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
Official Title: Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Caregiver Anxiety [ Time Frame: change in anxiety 5, 7, 15 weeks post-baseline ] [ Designated as safety issue: No ]
    Profile of Moods States (POMS) anxiety sub-scale


Secondary Outcome Measures:
  • Spirituality [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]
    Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale

  • Depression [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]
    Centers for Epidemiologic Study of Depression short form (CESD)

  • Anticipatory grief [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]
    Anticipatory Grief Scale

  • Patient days at home [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]
    number of patient days at home

  • Caregiver burden [ Time Frame: change in burden 5, 7 and 11 weeks post-baseline ] [ Designated as safety issue: No ]
    Caregiver Reaction Assessment (CRA)

  • Caregiver completion and preparation [ Time Frame: change in preparation and completion 5, 7, 15 weeks post-baseline ] [ Designated as safety issue: No ]
    quality of family experience (QUAL-E fam)

  • Prolonged Grief [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]
    Prolonged Grief 12 (PG-12) scale


Enrollment: 418
Study Start Date: June 2013
Study Completion Date: April 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver
Other: Preparation and life completion
Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.
Active Comparator: attention control
three facilitator led sessions of listening to a relaxation CD.
Other: Attention Control
Caregiver subjects will listen to a non-guided relaxation CD with facilitator.

Detailed Description:

The investigators propose a randomized control trial to evaluate an intervention of end-of-life preparation and completion with Veterans and their caregivers at end-of-life. Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the impact of the home versus in hospital, emergency department, or nursing facility; 3) Evaluate the impact of the intervention session's qualitative content, examining variation associated with selected demographic variables, quality of family communication, and stage of illness on change.

Caregivers in the first group ("treatment") will meet with a facilitator three times for a period of forty-five minutes each. In the first session, subjects will be asked to discuss issues related to relationship life review.

In session two, participants will be asked to speak in more depth about issues such as regret and forgiveness. In the final session, subjects will focus on legacy and celebration. Caregivers in the second group ("attention control") will meet with a facilitator three times for a period of forty-five minutes each and be asked to listen to a non-guided relaxation CD or participate in a guided relaxation exercise.

Participants in both groups will receive pre and post-test measures administered by a blinded interviewer. Outcome measures will be measures by the Functional Assessment of Cancer Therapy - General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory Grief Scale, Caregiver Reaction Assessment, the Qual-E completion and preparation sub-scales, and patient days at home.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease who have a primary caregiver. Caregivers of Durham VAMC patients with advanced disease.

Exclusion Criteria:

  • No caregiver present.
  • Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672294

Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Karen E Steinhauser, PhD Durham VA Medical Center, Durham, NC
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01672294     History of Changes
Other Study ID Numbers: IIR 11-347 
Study First Received: May 11, 2012
Last Updated: July 8, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
caregiver
end of life
self-disclosure

Additional relevant MeSH terms:
Lung Diseases
Heart Failure
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2016