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Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness


N/A
18 Years
N/A
Open (Enrolling)
Both
Heart Failure, Pulmonary Disease, Cancer

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Trial Information

Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness


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.

Participants in both groups will receive pre and post-test measures administered by a
blinded interviewer. Outcome measures will be measures by the 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.


Inclusion Criteria:



- Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease
who have a primary caregiver

Exclusion Criteria:

- No caregiver present.

- Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Caregiver Anxiety

Outcome Description:

POMS anxiety sub-scale

Outcome Time Frame:

change in anxiety 5, 7, 15 weeks post-baseline

Safety Issue:

No

Principal Investigator

Karen E. Steinhauser, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Durham VA Medical Center HSR&D COE

Authority:

United States: Federal Government

Study ID:

IIR 11-347

NCT ID:

NCT01672294

Start Date:

June 2013

Completion Date:

June 2015

Related Keywords:

  • Heart Failure
  • Pulmonary Disease
  • Cancer
  • caregiver
  • end of life
  • self-disclosure
  • Heart Failure
  • Lung Diseases
  • Respiration Disorders

Name

Location

Durham VA Medical Center HSR&D COE Durham, North Carolina  27705