Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
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Purpose
Informal caregivers provide a majority of care for patients at the end of life. Lack of end of life 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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness |
- Caregiver Anxiety [ Time Frame: change in anxiety 5, 7, 15 weeks post-baseline ] [ Designated as safety issue: No ]POMS anxiety sub-scale
- Spirituality [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]FACIT-SP subscale
- Depression [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]Centers for Epidemiologic Study of Depression short form (CESD)
- Anticipatory grief [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]Anticipatory Grief Scale
- Patient days at home [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]number of patient days at home
- Caregiver burden [ Time Frame: change in burden 5, 7 and 11 weeks post-baseline ] [ Designated as safety issue: No ]Caregiver Reaction Assessment (CRA)
- Caregiver completion and preparation [ Time Frame: change in preparation and completion 5, 7, 15 weeks post-baseline ] [ Designated as safety issue: No ]QUAL-E fam
- Prolonged Grief [ Time Frame: 5 and 7 weeks post-baseline ] [ Designated as safety issue: No ]PG-12 (Prolonged Grief 12 scale)
| Estimated Enrollment: | 418 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Andrew Ovenden, MA PhD | andrew.ovenden@va.gov | |
| Contact: Jennifer B Zervakis, PhD | (919) 286-6936 | jennifer.zervakis@va.gov |
| United States, North Carolina | |
| Durham VA Medical Center HSR&D COE | Not yet recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Susan B Armstrong 919-286-6936 beth.armstrong@va.gov | |
| Contact: Dana C Tucker (919) 286-0411 ext 5741 dana.tucker@va.gov | |
| Sub-Investigator: Courtney H. Van Houtven, PhD | |
| Sub-Investigator: James A. Tulsky, MD | |
| Principal Investigator: Karen E. Steinhauser, PhD | |
| Sub-Investigator: Stewart C. Alexander, BA MA PhD | |
| Principal Investigator: | Karen E. Steinhauser, PhD | Durham VA Medical Center HSR&D COE |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01672294 History of Changes |
| Other Study ID Numbers: | IIR 11-347 |
| Study First Received: | May 11, 2012 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
caregiver end of life self-disclosure |
Additional relevant MeSH terms:
|
Heart Failure Lung Diseases Respiration Disorders |
Heart Diseases Cardiovascular Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013