Clinical trial NCT01672294: Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
Official title: Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Pulmonary Disease
Cancer
Keywords: caregiver
end of life
self-disclosure
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-08-24
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Caregiver Anxiety
timeFrame: Measured at baseline, 5 weeks, and 8 weeks
Secondary outcomes:
measure: Spirituality
timeFrame: Measured at baseline, 5 weeks, and 8 weeks
measure: Depression
timeFrame: Measured at baseline, 5 weeks, and 8 weeks
measure: Patient Days of VA Hospital Use
timeFrame: In the 6 months after randomization
measure: Caregiver Burden
timeFrame: Measured at baseline, 5 weeks, and 8 weeks
measure: Caregiver Completion
timeFrame: Measured at baseline, 5 weeks, and 8 weeks
measure: Prolonged Grief - Number of Participants With Anticipatory Grief
timeFrame: Measured at baseline, 5 weeks, and 8 weeks
measure: Caregiver Preparation
timeFrame: Measured at baseline, 5 weeks, and 8 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Karen E Steinhauser, PhD
role: PRINCIPAL_INVESTIGATOR
References: