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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver |
|
| attention control | Active Comparator | three facilitator led sessions of listening to a relaxation CD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preparation and life completion | Other | Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Anxiety | 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 ). | Measured at baseline, 5 weeks, and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Spirituality | 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). | Measured at baseline, 5 weeks, and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen E Steinhauser, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
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Participant pairs (seriously-ill veteran and primary informal caregiver) were consented and then each completed a baseline interview before the dyad was randomized. Enrolled participants may be excluded if either of the pair refused to consent or did not complete a baseline.
The study conducted recruitment from June 2013 to October 2015. Potential patients were identified by data pulls and then medical record review as well as obtaining approval to approach from providers. Patients were approached both at select outpatient clinics at the Durham VAMC as well as being sent invitation letters with subsequent phone calls.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caregiver Outlook - Caregiver | Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. |
| FG001 | Caregiver Outlook - Patient | Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. |
| FG002 | Relaxation Meditation - Caregiver | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. |
| FG003 | Relaxation Meditation - Patient | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregiver Outlook - Caregiver | Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. |
| BG001 | Caregiver Outlook - Patient |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Caregiver Anxiety | 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 ). | Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline, 5 weeks, and 8 weeks |
|
During time of study participation, 8 weeks per participant. Adverse events were collected both systematically, by asking of events at each time point, and non-systematically.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caregiver Outlook - Caregiver | Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Steinhauser, PhD | VA HSRD Durham VA Medical Center | 9196682148 | karen.steinhauser@va.gov |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D008171 | Lung Diseases |
| D009369 | Neoplasms |
| D003643 | Death |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
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| Attention Control | Other | Caregiver subjects will listen to a non-guided relaxation CD with facilitator. |
|
| Depression | 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 | Measured at baseline, 5 weeks, and 8 weeks |
| Patient Days of VA Hospital Use | 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. | In the 6 months after randomization |
| Caregiver Burden | 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. | Measured at baseline, 5 weeks, and 8 weeks |
| Caregiver Completion | 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). | Measured at baseline, 5 weeks, and 8 weeks |
| Prolonged Grief - Number of Participants With Anticipatory Grief | 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. | Measured at baseline, 5 weeks, and 8 weeks |
| Caregiver Preparation | 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). | Measured at baseline, 5 weeks, and 8 weeks |
| Excluded by study |
|
| Lost to Follow-up |
|
Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. |
| BG002 | Relaxation Meditation - Caregiver | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. |
| BG003 | Relaxation Meditation - Patient | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | NIH/OMB categories collapsed to: African-American\Black, Caucasian\White Other including more than 1 race, missing | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dyad Relationship | Respective relationship of participant to other dyad in pair. | Count of Participants | Participants |
|
| Primary Diagnosis of Veteran | Primary life-limiting diagnosis of Veteran patient | Primary diagnosis of veteran only collected from patient half of dyad, which =143 | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Finances | Self-reported household finances by participant | Count of Participants | Participants |
|
| Employment | Self-reported employment | Count of Participants | Participants |
|
| Self-rated Quality of Health | Count of Participants | Participants |
|
| Years of caregiving given or received | Self-reported years spent caregiving or years received caregiving | Mean | Standard Deviation | years |
|
| Number of Hours patient requires assistance | Self-reported number of hours patient requires assistance | Mean | Standard Deviation | hours |
|
| Relaxation Meditation - Caregiver |
Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control). |
|
|
|
| Secondary | Spirituality | 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). | Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline, 5 weeks, and 8 weeks |
|
|
|
|
| Secondary | Depression | 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 | Primary and secondary results are comparing caregiver scores in the two arms, not patient arms. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline, 5 weeks, and 8 weeks |
|
|
|
|
| Secondary | Patient Days of VA Hospital Use | 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. | Posted | Mean | Standard Deviation | Days in VA hospital or ER | In the 6 months after randomization |
|
|
|
|
| Secondary | Caregiver Burden | 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. | Comparing Caregiver reaction assessment scores between the Outlook Intervention and the Relaxation Meditation arm.Differences in numbers analyzed versus group totals due to missing data. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline, 5 weeks, and 8 weeks |
|
|
|
|
| Secondary | Caregiver Completion | 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). | Comparing life completion scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Differences in numbers analyzed versus group totals due to missing data. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline, 5 weeks, and 8 weeks |
|
|
|
|
| Secondary | Prolonged Grief - Number of Participants With Anticipatory Grief | 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. | Number of participants indicating prolonged grief across the Outlook Intervention and the Relaxation meditation arm, caregivers only. Only six percent of the sample qualified as having prolonged grief, at baseline. Therefore there was not sufficient data for statistical modeling. | Posted | Number | participants | Measured at baseline, 5 weeks, and 8 weeks |
|
|
|
| Secondary | Caregiver Preparation | 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). | Comparing preparation scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Two scale items were inadvertently left out initially. Items were added back in when omission was noted. However, the large number of missing makes analysis inappropriate. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline, 5 weeks, and 8 weeks |
|
|
|
| 0 |
| 71 |
| 4 |
| 71 |
| EG001 | Caregiver Outlook - Patient | Patients of the caregivers in the Outlook Intervention arm. | 13 | 71 | 7 | 71 |
| EG002 | Relaxation Meditation - Caregiver | Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. | 0 | 72 | 4 | 72 |
| EG003 | Relaxation Meditation - Patient | Patients of the caregivers in the Attention Control arm. | 11 | 72 | 11 | 72 |
| Gastro-Intestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Renal | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Neoplasm-death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Psychiatric | Psychiatric disorders | Non-systematic Assessment |
|
| Vascular/blood | Vascular disorders | Non-systematic Assessment |
|
| Multiple/general | General disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| 5 week |
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| 8 week |
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Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.
| Mixed Models Analysis |
| 0.1972 |
| Mean Difference (Final Values) |
| 1.2764 |
| 2-Sided |
| 95 |
| -0.6728 |
| 3.2257 |
| Superiority or Other |
| 5 weeks |
|
|
| 7 weeks |
|
|
Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks |
| Mixed Models Analysis |
| 0.3842 |
Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks |
| Mean Difference (Final Values) |
| 0.6929 |
| 2-Sided |
| 95 |
| -0.8783 |
| 2.2642 |
| Superiority or Other |
| 5 week |
|
|
| 8 week |
|
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|
Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks. |
| Mixed Models Analysis |
| 0.9863 |
Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks |
| Mean Difference (Final Values) |
| -0.00087 |
| 2-Sided |
| 95 |
| -0.1003 |
| 0.09861 |
| Superiority or Other |
| 5 Week |
|
|
| 8 Week |
|
|
| Mixed Models Analysis |
| 0.3249 |
Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks |
| Mean Difference (Final Values) |
| -0.1154 |
| 2-Sided |
| 95 |
| -0.3466 |
| 0.1158 |
| Superiority or Other |
| 5 week |
|
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| 8 week |
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| 5 Week |
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| 8 Week |
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