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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: March 3, 2017
Last verified: March 2017
  Purpose

Informal caregivers provide a majority of care for patients during serious illness. Lack of 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
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
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: Measured at baseline, 5 weeks, and 8 weeks ]
    Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).


Secondary Outcome Measures:
  • Spirituality [ Time Frame: Measured at baseline, 5 weeks, and 8 weeks ]
    Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).

  • Depression [ Time Frame: Measured at baseline, 5 weeks, and 8 weeks ]
    Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms

  • Patient Days of VA Hospital Use [ Time Frame: In the 6 months after randomization ]
    The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.

  • Caregiver Burden [ Time Frame: Measured at baseline, 5 weeks, and 8 weeks ]
    Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.

  • Caregiver Completion [ Time Frame: Measured at baseline, 5 weeks, and 8 weeks ]
    Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).

  • Prolonged Grief - Number of Participants With Anticipatory Grief [ Time Frame: Measured at baseline, 5 weeks, and 8 weeks ]
    The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.

  • Caregiver Preparation [ Time Frame: Measured at baseline, 5 weeks, and 8 weeks ]
    Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).


Enrollment: 286
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 preparation and completion with Veterans and their caregivers during serious illness. 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", or "Preparation and life completion") 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" or "relaxation meditation") 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 compact disk (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)
Sexes Eligible for Study:   All
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
Results First Received: January 6, 2017
Last Updated: March 3, 2017
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:
Heart Failure
Lung Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 26, 2017