Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure Pulmonary Disease Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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treatment

three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver

Group Type EXPERIMENTAL

Preparation and life completion

Intervention Type OTHER

Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.

attention control

three facilitator led sessions of listening to a relaxation CD.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type OTHER

Caregiver subjects will listen to a non-guided relaxation CD with facilitator.

Interventions

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Preparation and life completion

Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.

Intervention Type OTHER

Attention Control

Caregiver subjects will listen to a non-guided relaxation CD with facilitator.

Intervention Type OTHER

Eligibility Criteria

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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.