Cancer, Heart Failure, Pulmonary Disease
Conditions
Keywords
caregiver, end of life, self-disclosure
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.
Interventions
OTHERPreparation and life completion
Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.
OTHERAttention Control
Caregiver subjects will listen to a non-guided relaxation CD with facilitator.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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). |
| 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| Caregiver Outlook - Patient Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy. | 71 |
| Relaxation Meditation - Caregiver Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. | 72 |
| Relaxation Meditation - Patient Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.. | 72 |
| Total | 286 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Excluded by study | 1 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 16 | 7 | 9 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | Total | Caregiver Outlook - Caregiver | Caregiver Outlook - Patient | Relaxation Meditation - Caregiver | Relaxation Meditation - Patient |
|---|---|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 10.59 | 60.8 years STANDARD_DEVIATION 11.32 | 66.8 years STANDARD_DEVIATION 7.85 | 60.1 years STANDARD_DEVIATION 12.05 | 65.4 years STANDARD_DEVIATION 9.21 |
| Dyad Relationship Adult Child | 12 Participants | 6 Participants | 2 Participants | 3 Participants | 1 Participants |
| Dyad Relationship Other | 40 Participants | 8 Participants | 8 Participants | 12 Participants | 12 Participants |
| Dyad Relationship Parent | 12 Participants | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Dyad Relationship Sibling | 12 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants |
| Dyad Relationship Spouse | 210 Participants | 52 Participants | 52 Participants | 53 Participants | 53 Participants |
| Education College Degree | 29 Participants | 12 Participants | 6 Participants | 5 Participants | 6 Participants |
| Education Graduate Work or Degree | 24 Participants | 3 Participants | 7 Participants | 8 Participants | 6 Participants |
| Education HS or less | 126 Participants | 34 Participants | 33 Participants | 28 Participants | 31 Participants |
| Education Some College | 107 Participants | 22 Participants | 25 Participants | 31 Participants | 29 Participants |
| Employment Disabled | 77 Participants | 7 Participants | 32 Participants | 10 Participants | 28 Participants |
| Employment Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Employment Retired/Not Working | 163 Participants | 43 Participants | 38 Participants | 42 Participants | 40 Participants |
| Employment Working Full or Part Time | 45 Participants | 21 Participants | 1 Participants | 19 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 277 Participants | 68 Participants | 69 Participants | 68 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Finances Difficulty paying bills | 35 Participants | 10 Participants | 13 Participants | 6 Participants | 6 Participants |
| Finances enough to pay bills and special things | 87 Participants | 22 Participants | 22 Participants | 21 Participants | 22 Participants |
| Finances Enough to pay bills, little extras | 101 Participants | 26 Participants | 22 Participants | 23 Participants | 30 Participants |
| Finances Missing | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Finances Money to pay bills, cut back on things | 62 Participants | 13 Participants | 14 Participants | 22 Participants | 13 Participants |
| Number of Hours patient requires assistance | 2.3 hours STANDARD_DEVIATION 1.26 | 2.4 hours STANDARD_DEVIATION 1.24 | 2.3 hours STANDARD_DEVIATION 1.34 | 2.3 hours STANDARD_DEVIATION 1.2 | 2.1 hours STANDARD_DEVIATION 1.25 |
| Primary Diagnosis of Veteran Cancer | 95 Participants | — | 43 Participants | — | 52 Participants |
| Primary Diagnosis of Veteran Chronic obstructive pulmonary disease | 17 Participants | — | 12 Participants | — | 5 Participants |
| Primary Diagnosis of Veteran Congestive Heart Failure | 12 Participants | — | 6 Participants | — | 6 Participants |
| Primary Diagnosis of Veteran End Stage Renal Disease | 12 Participants | — | 6 Participants | — | 6 Participants |
| Primary Diagnosis of Veteran Multiple Qualifying Disease | 7 Participants | — | 4 Participants | — | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 122 Participants | 31 Participants | 29 Participants | 30 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 17 Participants | 4 Participants | 4 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 145 Participants | 36 Participants | 38 Participants | 33 Participants | 38 Participants |
| Region of Enrollment United States | 286 participants | 71 participants | 71 participants | 72 participants | 72 participants |
| Self-rated Quality of Health Excellent | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Self-rated Quality of Health Fair | 46 Participants | 9 Participants | 14 Participants | 9 Participants | 14 Participants |
| Self-rated Quality of Health Good | 49 Participants | 16 Participants | 11 Participants | 14 Participants | 8 Participants |
| Self-rated Quality of Health Missing | 141 Participants | 36 Participants | 36 Participants | 35 Participants | 34 Participants |
| Self-rated Quality of Health Poor | 21 Participants | 0 Participants | 9 Participants | 0 Participants | 12 Participants |
| Self-rated Quality of Health Very Good | 28 Participants | 10 Participants | 1 Participants | 13 Participants | 4 Participants |
| Sex: Female, Male Female | 141 Participants | 67 Participants | 4 Participants | 67 Participants | 3 Participants |
| Sex: Female, Male Male | 145 Participants | 4 Participants | 67 Participants | 5 Participants | 69 Participants |
| Years of caregiving given or received | 4.2 years STANDARD_DEVIATION 5.04 | 4.6 years STANDARD_DEVIATION 5.6 | 5.2 years STANDARD_DEVIATION 5.95 | 3.7 years STANDARD_DEVIATION 4.06 | 3.4 years STANDARD_DEVIATION 4.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 71 | 7 / 71 | 4 / 72 | 11 / 72 |
| serious Total, serious adverse events | 0 / 71 | 13 / 71 | 0 / 72 | 11 / 72 |
Outcome results
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 ).
Time frame: Measured at baseline, 5 weeks, and 8 weeks
Population: Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Outlook - Caregiver | Caregiver Anxiety | Baseline | 6.9 units on a scale | Standard Deviation 5.3 |
| Caregiver Outlook - Caregiver | Caregiver Anxiety | 5 week follow up | 5.9 units on a scale | Standard Deviation 5.2 |
| Caregiver Outlook - Caregiver | Caregiver Anxiety | 8 week follow up | 5.8 units on a scale | Standard Deviation 5.7 |
| Relaxation Meditation - Caregiver | Caregiver Anxiety | Baseline | 7.3 units on a scale | Standard Deviation 4.6 |
| Relaxation Meditation - Caregiver | Caregiver Anxiety | 5 week follow up | 5.4 units on a scale | Standard Deviation 4.9 |
| Relaxation Meditation - Caregiver | Caregiver Anxiety | 8 week follow up | 6.4 units on a scale | Standard Deviation 5.1 |
Comparison: Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.p-value: <0.51195% CI: [-1.0776, 2.1528]Mixed Models Analysis
Comparison: Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.p-value: 0.634895% CI: [-1.3505, 2.2055]Mixed Models Analysis
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.
Time frame: Measured at baseline, 5 weeks, and 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Outlook - Caregiver | Caregiver Burden | Baseline | 4.2 units on a scale | Standard Deviation 0.6 |
| Caregiver Outlook - Caregiver | Caregiver Burden | 5 week | 4.2 units on a scale | Standard Deviation 0.6 |
| Caregiver Outlook - Caregiver | Caregiver Burden | 8 week | 4.2 units on a scale | Standard Deviation 0.6 |
| Relaxation Meditation - Caregiver | Caregiver Burden | Baseline | 4.2 units on a scale | Standard Deviation 0.6 |
| Relaxation Meditation - Caregiver | Caregiver Burden | 5 week | 4.2 units on a scale | Standard Deviation 0.6 |
| Relaxation Meditation - Caregiver | Caregiver Burden | 8 week | 4.1 units on a scale | Standard Deviation 0.6 |
Comparison: Between Outlook Intervention caregivers and active control caregivers at 5 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.p-value: 0.768795% CI: [-0.1372, 0.1017]Mixed Models Analysis
Comparison: 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.p-value: 0.986395% CI: [-0.1003, 0.09861]Mixed Models Analysis
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).
Time frame: Measured at baseline, 5 weeks, and 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Outlook - Caregiver | Caregiver Completion | Baseline | 2.7 units on a scale | Standard Deviation 0.8 |
| Caregiver Outlook - Caregiver | Caregiver Completion | 5 Week | 2.5 units on a scale | Standard Deviation 0.9 |
| Caregiver Outlook - Caregiver | Caregiver Completion | 8 Week | 2.5 units on a scale | Standard Deviation 1 |
| Relaxation Meditation - Caregiver | Caregiver Completion | Baseline | 2.8 units on a scale | Standard Deviation 0.8 |
| Relaxation Meditation - Caregiver | Caregiver Completion | 5 Week | 2.6 units on a scale | Standard Deviation 0.9 |
| Relaxation Meditation - Caregiver | Caregiver Completion | 8 Week | 2.7 units on a scale | Standard Deviation 0.8 |
Comparison: At 5 weeks - Completion subscalep-value: 0.922195% CI: [-0.2475, 0.2241]Mixed Models Analysis
Comparison: Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.p-value: 0.324995% CI: [-0.3466, 0.1158]Mixed Models Analysis
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).
Time frame: Measured at baseline, 5 weeks, and 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Outlook - Caregiver | Caregiver Preparation | Baseline | 2.7 units on a scale | Standard Deviation 0.7 |
| Caregiver Outlook - Caregiver | Caregiver Preparation | 5 Week | 2.4 units on a scale | Standard Deviation 0.8 |
| Caregiver Outlook - Caregiver | Caregiver Preparation | 8 Week | 2.6 units on a scale | Standard Deviation 0.8 |
| Relaxation Meditation - Caregiver | Caregiver Preparation | Baseline | 2.4 units on a scale | Standard Deviation 0.8 |
| Relaxation Meditation - Caregiver | Caregiver Preparation | 5 Week | 2.7 units on a scale | Standard Deviation 0.7 |
| Relaxation Meditation - Caregiver | Caregiver Preparation | 8 Week | 2.6 units on a scale | Standard Deviation 0.8 |
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
Time frame: Measured at baseline, 5 weeks, and 8 weeks
Population: Primary and secondary results are comparing caregiver scores in the two arms, not patient arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Outlook - Caregiver | Depression | Baseline | 8.2 units on a scale | Standard Deviation 6.6 |
| Caregiver Outlook - Caregiver | Depression | 5 weeks | 8.7 units on a scale | Standard Deviation 6.8 |
| Caregiver Outlook - Caregiver | Depression | 7 weeks | 8.3 units on a scale | Standard Deviation 6.2 |
| Relaxation Meditation - Caregiver | Depression | Baseline | 8.8 units on a scale | Standard Deviation 5.5 |
| Relaxation Meditation - Caregiver | Depression | 5 weeks | 8.0 units on a scale | Standard Deviation 6.4 |
| Relaxation Meditation - Caregiver | Depression | 7 weeks | 9.0 units on a scale | Standard Deviation 6.4 |
Comparison: Between Outlook Intervention caregivers and active control caregivers at 5 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.p-value: <0.333295% CI: [-0.9726, 2.8443]Mixed Models Analysis
Comparison: 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 weeksp-value: 0.384295% CI: [-0.8783, 2.2642]Mixed Models Analysis
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.
Time frame: In the 6 months after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver Outlook - Caregiver | Patient Days of VA Hospital Use | 4.4 Days in VA hospital or ER | Standard Deviation 11.8 |
| Relaxation Meditation - Caregiver | Patient Days of VA Hospital Use | 4.4 Days in VA hospital or ER | Standard Deviation 9.6 |
p-value: 0.874895% CI: [-0.6784, 0.797]Standard negative binomial with offset
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.
Time frame: Measured at baseline, 5 weeks, and 8 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caregiver Outlook - Caregiver | Prolonged Grief - Number of Participants With Anticipatory Grief | Baseline | 6 participants |
| Caregiver Outlook - Caregiver | Prolonged Grief - Number of Participants With Anticipatory Grief | 5 week | 2 participants |
| Caregiver Outlook - Caregiver | Prolonged Grief - Number of Participants With Anticipatory Grief | 8 week | 2 participants |
| Relaxation Meditation - Caregiver | Prolonged Grief - Number of Participants With Anticipatory Grief | Baseline | 2 participants |
| Relaxation Meditation - Caregiver | Prolonged Grief - Number of Participants With Anticipatory Grief | 5 week | 3 participants |
| Relaxation Meditation - Caregiver | Prolonged Grief - Number of Participants With Anticipatory Grief | 8 week | 2 participants |
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).
Time frame: Measured at baseline, 5 weeks, and 8 weeks
Population: Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregiver Outlook - Caregiver | Spirituality | Baseline | 35.4 units on a scale | Standard Deviation 9 |
| Caregiver Outlook - Caregiver | Spirituality | 5 week | 36.1 units on a scale | Standard Deviation 8 |
| Caregiver Outlook - Caregiver | Spirituality | 8 week | 37.3 units on a scale | Standard Deviation 8.3 |
| Relaxation Meditation - Caregiver | Spirituality | Baseline | 37.3 units on a scale | Standard Deviation 7.2 |
| Relaxation Meditation - Caregiver | Spirituality | 5 week | 37.3 units on a scale | Standard Deviation 7 |
| Relaxation Meditation - Caregiver | Spirituality | 8 week | 36.6 units on a scale | Standard Deviation 7.6 |
Comparison: Comparison at 5 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.p-value: 0.522595% CI: [-1.4278, 2.795]Mixed Models Analysis
Comparison: 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.p-value: 0.197295% CI: [-0.6728, 3.2257]Mixed Models Analysis