Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness

Not Applicable

Completed

• Conditions: Heart Failure; Pulmonary Disease; Cancer
• Interventions: Other: Attention Control; Other: Preparation and life completion

• Registration Number: NCT01672294
• Lead Sponsor: VA Office of Research and Development

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-24
• Study Start: 2013-06
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Results First Submitted: 2017-01-06
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-03
• Last Update Submitted: 2017-03-03
• Results First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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.

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Exclusion Criteria

• No caregiver present.
• Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
attention control	Attention Control	three facilitator led sessions of listening to a relaxation CD.
treatment	Preparation and life completion	three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver

Primary Outcome Measures

Name	Time	Method
Caregiver Anxiety	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

Name	Time	Method
Caregiver Preparation	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).
Prolonged Grief - Number of Participants With Anticipatory Grief	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.
Spirituality	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	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	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	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	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).

Trial Locations

Locations (1)

Durham VA Medical Center, Durham, NC; 🇺🇸 Durham, North Carolina, United States