Cancer, Pain
Conditions
Keywords
hospice, caregiver
Brief summary
The project will test the effect of educating and supporting family caregivers of hospice cancer patients on their active participation in shared decision making in the plan of care for their patients.
Detailed description
This intervention will target education and emotional support to family caregivers of hospice cancer patients for a shared decision making process in the hospice care plan meetings The intervention ACCESS will consist of three components: 1: a Facebook group to provide the education and support; 2. web conferencing for family members into the hospice interdisciplinary care plan meeting 3, a structured shared decision making process to guide the team discussion. Participants (family caregivers) will be randomly assigned to one of three groups, usual care, Facebook only, and Access. The specific aims are to: 1. Evaluate the effect of access on family caregiver anxiety, pain knowledge and patient pain. 2. Evaluate the effect of Facebook groups as educational emotional support for family caregivers 3. Assess staff and family caregiver satisfaction with the shared decision making process.
Interventions
BEHAVIORALFacebook
Participants will be enrolled in a Secret Facebook group for social support and education
BEHAVIORALACCESS
Intervention will have two components. 1. Participants will be enrolled in a Secret Facebook group for social support and education 2. Participants will use web conferencing technology to participate in their interdisciplinary team meeting
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A pragmatic cluster randomized controlled trial will randomly assign hospice sites (cluster) to 2 of 3 groups: 1) Enhanced usual care 2) Enhanced usual care and private Facebook group 3) Enhanced usual care, private Facebook group, and ACCESS. Each hospice site (cluster) will go through 2 arms of the intervention but the family caregiver participants will only complete one arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is caregiving for a patient enrolled in the participating hospice * Over 18 years of age * Is caregiving for a patient with a diagnosis of cancer * Willing to have a Facebook account and post at least 1x per week if in intervention group
Exclusion criteria
* No one under the age of 18 * Is caregiving for a patient enrolled in hospice agencies other than those participating in the study * Unwilling to participate in social media * Is caregiving for a patient with a diagnosis other than cancer * Is caregiving for a patient with a life expectancy of less than 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Generalized Anxiety Disorder- 7 | Upon enrollment, 14 days, 28 days, 60 days and 90 days | A screening tool to quantify participant's anxiety. The scale ranges from 0-21. A higher score indicates a higher level of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Family Pain Questionnaire - Knowledge | Upon enrollment and 28 days | A scale which measures pain knowledge. The scale ranges from 0-90. A higher score indicates a higher knowledge of pain. |
| Change in Caregiver Quality of Life | Upon enrollment, 14 days, 28 days, 60 days and 90 days | Four question scale that measures caregivers quality of life. Scale ranges from 0-40. Higher score indicates higher quality of life. |
| Perceived Involvement of Care Scale | Upon enrollment, 14 days, 28 days, and 90 days | A scale measuring perceived involvement of care. Scale ranges from 13-65. Higher score indicates higher perceived involvement in care. |
| Change in Family Pain Questionnaire - Experience | Upon enrollment and 28 days | A scale which measures caregiver's experience dealing with patient pain. Scale ranges from 0-70. A higher score indicates higher pain experience. |
| Edmonton Symptom Assessment | Upon enrollment, 14 days, 28 days, 60 days, and 90 days | A scale that measures various patient symptoms as reported by caregiver such as pain, fatigue, depression, anxiety, appetite, and nausea. Scale ranges from 0-90. A higher score indicates higher degree of symptoms. |
| Zarit Burden Scale | Upon enrollment and 28 days | A scale that measures the level of burden on caregiver. Scale ranges from 0-28. A higher score indicates greater burden. |
| Caregiver Communication Questionnaire (CCCQ) | 14 days, 28 days, and 60 days | A scale that measures the level of perception of caregiver centered communication by hospice staff. Scale ranges from 30-150. A higher score indicates greater perception of caregiver centered communication. |
| Public Health Questionnaire (PHQ 9) | Upon enrollment, 14 days, 28 days, 60 days, and 90 days | A measure of depression. Scale ranges from 0-27. A higher score indicates higher depression. |
Countries
United States
Participant flow
Recruitment details
This is a crossover cluster-randomized study where 7 hospice sites were assigned to an intervention sequence consisting of 2 of the 3 interventions: Facebook, Enhanced UsualCare, or ACCESS. There was at least one washout period of up to 90 days between interventions. The intervention for the hospice sites also started at different times.
Pre-assignment details
Hospice patients were not enrolled to this study. Only family caregivers were enrolled to this study. Each family caregiver was only assigned to one group (intervention) and stayed in that group for the duration of their time in the study (up to 90 days). They were given surveys at 14, 28, 60, and 90 days. The number of family caregivers who received each intervention at each site is listed below.
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Usual Care The family caregivers in this group will receive usual hospice care which has been enhanced as the staff have been trained in shared decision making. | 126 |
| Facebook The family caregivers in this group only participates in the Facebook groups, not in the shared decision making | 214 |
| ACCESS The family caregivers in this group participates in Facebook and web conferencing for shared decision making | 149 |
| Total | 489 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Hospice patient death | 100 | 64 | 28 | 46 | 55 | 28 | 78 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | ACCESS | |
|---|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 12.2 | 56.2 years STANDARD_DEVIATION 12.4 | 56.5 years STANDARD_DEVIATION 12 | 55.0 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 10 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants | 475 Participants | 141 Participants | 209 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 56 Participants | 16 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 9 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 118 Participants | 415 Participants | 125 Participants | 172 Participants |
| Region of Enrollment United States | 126 participants | 489 participants | 149 participants | 214 participants |
| Sex: Female, Male Female | 87 Participants | 375 Participants | 119 Participants | 169 Participants |
| Sex: Female, Male Male | 39 Participants | 113 Participants | 29 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 214 | 0 / 149 |
| other Total, other adverse events | 0 / 126 | 0 / 214 | 0 / 149 |
| serious Total, serious adverse events | 0 / 126 | 0 / 214 | 0 / 149 |
Outcome results
Primary
Change in Generalized Anxiety Disorder- 7
A screening tool to quantify participant's anxiety. The scale ranges from 0-21. A higher score indicates a higher level of anxiety.
Time frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Change in Generalized Anxiety Disorder- 7 | 60 days | 5.06 score on a scale | Standard Deviation 4.82 |
| Enhanced Usual Care | Change in Generalized Anxiety Disorder- 7 | 28 days | 6.81 score on a scale | Standard Deviation 5.74 |
| Enhanced Usual Care | Change in Generalized Anxiety Disorder- 7 | Baseline (upon enrollment) | 7.73 score on a scale | Standard Deviation 5.84 |
| Enhanced Usual Care | Change in Generalized Anxiety Disorder- 7 | 14 days | 7.06 score on a scale | Standard Deviation 5.97 |
| Enhanced Usual Care | Change in Generalized Anxiety Disorder- 7 | 90 days | 6.43 score on a scale | Standard Deviation 5.52 |
| Change in Generalized Anxiety Disorder- 7 | 28 days | 6.02 score on a scale | Standard Deviation 4.5 | |
| Change in Generalized Anxiety Disorder- 7 | Baseline (upon enrollment) | 8.81 score on a scale | Standard Deviation 5.98 | |
| Change in Generalized Anxiety Disorder- 7 | 14 days | 6.93 score on a scale | Standard Deviation 5.28 | |
| Change in Generalized Anxiety Disorder- 7 | 60 days | 6.54 score on a scale | Standard Deviation 4.2 | |
| Change in Generalized Anxiety Disorder- 7 | 90 days | 6.10 score on a scale | Standard Deviation 3.91 | |
| ACCESS | Change in Generalized Anxiety Disorder- 7 | 90 days | 7.43 score on a scale | Standard Deviation 4.52 |
| ACCESS | Change in Generalized Anxiety Disorder- 7 | 60 days | 8.81 score on a scale | Standard Deviation 5.69 |
| ACCESS | Change in Generalized Anxiety Disorder- 7 | Baseline (upon enrollment) | 8.42 score on a scale | Standard Deviation 5.73 |
| ACCESS | Change in Generalized Anxiety Disorder- 7 | 28 days | 7.55 score on a scale | Standard Deviation 4.98 |
| ACCESS | Change in Generalized Anxiety Disorder- 7 | 14 days | 7.39 score on a scale | Standard Deviation 5.03 |
Secondary
Caregiver Communication Questionnaire (CCCQ)
A scale that measures the level of perception of caregiver centered communication by hospice staff. Scale ranges from 30-150. A higher score indicates greater perception of caregiver centered communication.
Time frame: 14 days, 28 days, and 60 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Caregiver Communication Questionnaire (CCCQ) | 60 days | 116 score on a scale | Standard Deviation 22.1 |
| Enhanced Usual Care | Caregiver Communication Questionnaire (CCCQ) | 14 days | 117 score on a scale | Standard Deviation 19.9 |
| Enhanced Usual Care | Caregiver Communication Questionnaire (CCCQ) | 28 days | 120 score on a scale | Standard Deviation 26.9 |
| Caregiver Communication Questionnaire (CCCQ) | 28 days | 119 score on a scale | Standard Deviation 20.9 | |
| Caregiver Communication Questionnaire (CCCQ) | 60 days | 116 score on a scale | Standard Deviation 21 | |
| Caregiver Communication Questionnaire (CCCQ) | 14 days | 112 score on a scale | Standard Deviation 22.5 | |
| ACCESS | Caregiver Communication Questionnaire (CCCQ) | 14 days | 117 score on a scale | Standard Deviation 20.7 |
| ACCESS | Caregiver Communication Questionnaire (CCCQ) | 60 days | 121 score on a scale | Standard Deviation 20 |
| ACCESS | Caregiver Communication Questionnaire (CCCQ) | 28 days | 114 score on a scale | Standard Deviation 24 |
Secondary
Change in Caregiver Quality of Life
Four question scale that measures caregivers quality of life. Scale ranges from 0-40. Higher score indicates higher quality of life.
Time frame: Upon enrollment, 14 days, 28 days, 60 days and 90 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Change in Caregiver Quality of Life | Baseline (upon enrollment) | 26.7 score on a scale | Standard Deviation 8.76 |
| Enhanced Usual Care | Change in Caregiver Quality of Life | 60 days | 27.0 score on a scale | Standard Deviation 8.12 |
| Enhanced Usual Care | Change in Caregiver Quality of Life | 28 days | 25.3 score on a scale | Standard Deviation 9.4 |
| Enhanced Usual Care | Change in Caregiver Quality of Life | 90 days | 26.3 score on a scale | Standard Deviation 8.03 |
| Enhanced Usual Care | Change in Caregiver Quality of Life | 14 days | 25.1 score on a scale | Standard Deviation 9.33 |
| Change in Caregiver Quality of Life | 28 days | 23.6 score on a scale | Standard Deviation 7.92 | |
| Change in Caregiver Quality of Life | Baseline (upon enrollment) | 24.4 score on a scale | Standard Deviation 8.26 | |
| Change in Caregiver Quality of Life | 14 days | 24.8 score on a scale | Standard Deviation 7.59 | |
| Change in Caregiver Quality of Life | 60 days | 22.6 score on a scale | Standard Deviation 8.06 | |
| Change in Caregiver Quality of Life | 90 days | 22.7 score on a scale | Standard Deviation 6.91 | |
| ACCESS | Change in Caregiver Quality of Life | 90 days | 23.4 score on a scale | Standard Deviation 6.73 |
| ACCESS | Change in Caregiver Quality of Life | 60 days | 21.9 score on a scale | Standard Deviation 8.57 |
| ACCESS | Change in Caregiver Quality of Life | Baseline (upon enrollment) | 24.9 score on a scale | Standard Deviation 8.19 |
| ACCESS | Change in Caregiver Quality of Life | 28 days | 22.6 score on a scale | Standard Deviation 7.14 |
| ACCESS | Change in Caregiver Quality of Life | 14 days | 24.3 score on a scale | Standard Deviation 7.6 |
Secondary
Change in Family Pain Questionnaire - Experience
A scale which measures caregiver's experience dealing with patient pain. Scale ranges from 0-70. A higher score indicates higher pain experience.
Time frame: Upon enrollment and 28 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Change in Family Pain Questionnaire - Experience | Baseline (upon enrollment) | 38.9 score on a scale | Standard Deviation 11 |
| Enhanced Usual Care | Change in Family Pain Questionnaire - Experience | 28 days | 39.3 score on a scale | Standard Deviation 10.7 |
| Change in Family Pain Questionnaire - Experience | Baseline (upon enrollment) | 40.9 score on a scale | Standard Deviation 10.8 | |
| Change in Family Pain Questionnaire - Experience | 28 days | 39.0 score on a scale | Standard Deviation 9.53 | |
| ACCESS | Change in Family Pain Questionnaire - Experience | Baseline (upon enrollment) | 40.2 score on a scale | Standard Deviation 11 |
| ACCESS | Change in Family Pain Questionnaire - Experience | 28 days | 40.8 score on a scale | Standard Deviation 9.88 |
Secondary
Change in Family Pain Questionnaire - Knowledge
A scale which measures pain knowledge. The scale ranges from 0-90. A higher score indicates a higher knowledge of pain.
Time frame: Upon enrollment and 28 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Change in Family Pain Questionnaire - Knowledge | Baseline (upon enrollment) | 53.2 score on a scale | Standard Deviation 12.4 |
| Enhanced Usual Care | Change in Family Pain Questionnaire - Knowledge | 28 days | 60.9 score on a scale | Standard Deviation 11.3 |
| Change in Family Pain Questionnaire - Knowledge | Baseline (upon enrollment) | 54.6 score on a scale | Standard Deviation 11.2 | |
| Change in Family Pain Questionnaire - Knowledge | 28 days | 55.2 score on a scale | Standard Deviation 11 | |
| ACCESS | Change in Family Pain Questionnaire - Knowledge | Baseline (upon enrollment) | 54.3 score on a scale | Standard Deviation 11 |
| ACCESS | Change in Family Pain Questionnaire - Knowledge | 28 days | 54.8 score on a scale | Standard Deviation 8.75 |
Secondary
Edmonton Symptom Assessment
A scale that measures various patient symptoms as reported by caregiver such as pain, fatigue, depression, anxiety, appetite, and nausea. Scale ranges from 0-90. A higher score indicates higher degree of symptoms.
Time frame: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Edmonton Symptom Assessment | 60 days | 43.9 score on a scale | Standard Deviation 15.6 |
| Enhanced Usual Care | Edmonton Symptom Assessment | 28 days | 51.6 score on a scale | Standard Deviation 17.7 |
| Enhanced Usual Care | Edmonton Symptom Assessment | Baseline (upon enrollment) | 45.6 score on a scale | Standard Deviation 15.9 |
| Enhanced Usual Care | Edmonton Symptom Assessment | 14 days | 43.6 score on a scale | Standard Deviation 16.3 |
| Enhanced Usual Care | Edmonton Symptom Assessment | 90 days | 51.2 score on a scale | Standard Deviation 17.6 |
| Edmonton Symptom Assessment | 28 days | 41.7 score on a scale | Standard Deviation 14.5 | |
| Edmonton Symptom Assessment | Baseline (upon enrollment) | 46.1 score on a scale | Standard Deviation 14.3 | |
| Edmonton Symptom Assessment | 14 days | 42.2 score on a scale | Standard Deviation 15.1 | |
| Edmonton Symptom Assessment | 60 days | 43.4 score on a scale | Standard Deviation 15.2 | |
| Edmonton Symptom Assessment | 90 days | 42.3 score on a scale | Standard Deviation 14.1 | |
| ACCESS | Edmonton Symptom Assessment | 90 days | 42.0 score on a scale | Standard Deviation 16.7 |
| ACCESS | Edmonton Symptom Assessment | 60 days | 45.4 score on a scale | Standard Deviation 14.2 |
| ACCESS | Edmonton Symptom Assessment | Baseline (upon enrollment) | 42.6 score on a scale | Standard Deviation 13.5 |
| ACCESS | Edmonton Symptom Assessment | 28 days | 27.5 score on a scale | Standard Deviation 10.3 |
| ACCESS | Edmonton Symptom Assessment | 14 days | 43.6 score on a scale | Standard Deviation 14.6 |
Secondary
Perceived Involvement of Care Scale
A scale measuring perceived involvement of care. Scale ranges from 13-65. Higher score indicates higher perceived involvement in care.
Time frame: Upon enrollment, 14 days, 28 days, and 90 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Perceived Involvement of Care Scale | Baseline (upon enrollment) | 44.1 score on a scale | Standard Deviation 8.69 |
| Enhanced Usual Care | Perceived Involvement of Care Scale | 14 days | 41.0 score on a scale | Standard Deviation 8.93 |
| Enhanced Usual Care | Perceived Involvement of Care Scale | 28 days | 41.8 score on a scale | Standard Deviation 10.8 |
| Enhanced Usual Care | Perceived Involvement of Care Scale | 90 days | 45.4 score on a scale | Standard Deviation 10.8 |
| Perceived Involvement of Care Scale | 90 days | 45.9 score on a scale | Standard Deviation 8.58 | |
| Perceived Involvement of Care Scale | Baseline (upon enrollment) | 43.7 score on a scale | Standard Deviation 10.6 | |
| Perceived Involvement of Care Scale | 28 days | 44.3 score on a scale | Standard Deviation 9.95 | |
| Perceived Involvement of Care Scale | 14 days | 42.5 score on a scale | Standard Deviation 9.35 | |
| ACCESS | Perceived Involvement of Care Scale | 90 days | 49.3 score on a scale | Standard Deviation 6.88 |
| ACCESS | Perceived Involvement of Care Scale | 14 days | 43.9 score on a scale | Standard Deviation 9.22 |
| ACCESS | Perceived Involvement of Care Scale | 28 days | 46.3 score on a scale | Standard Deviation 6.24 |
| ACCESS | Perceived Involvement of Care Scale | Baseline (upon enrollment) | 42.9 score on a scale | Standard Deviation 8.85 |
Secondary
Public Health Questionnaire (PHQ 9)
A measure of depression. Scale ranges from 0-27. A higher score indicates higher depression.
Time frame: Upon enrollment, 14 days, 28 days, 60 days, and 90 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Public Health Questionnaire (PHQ 9) | 60 days | 4.74 score on a scale | Standard Deviation 5.24 |
| Enhanced Usual Care | Public Health Questionnaire (PHQ 9) | 28 days | 6.37 score on a scale | Standard Deviation 6.47 |
| Enhanced Usual Care | Public Health Questionnaire (PHQ 9) | Baseline (upon enrollment) | 7.05 score on a scale | Standard Deviation 6.59 |
| Enhanced Usual Care | Public Health Questionnaire (PHQ 9) | 14 days | 6.43 score on a scale | Standard Deviation 6.37 |
| Enhanced Usual Care | Public Health Questionnaire (PHQ 9) | 90 days | 5.50 score on a scale | Standard Deviation 4.98 |
| Public Health Questionnaire (PHQ 9) | 28 days | 6.18 score on a scale | Standard Deviation 4.86 | |
| Public Health Questionnaire (PHQ 9) | Baseline (upon enrollment) | 7.88 score on a scale | Standard Deviation 6.2 | |
| Public Health Questionnaire (PHQ 9) | 14 days | 6.30 score on a scale | Standard Deviation 5.24 | |
| Public Health Questionnaire (PHQ 9) | 60 days | 6.20 score on a scale | Standard Deviation 4.65 | |
| Public Health Questionnaire (PHQ 9) | 90 days | 5.59 score on a scale | Standard Deviation 4.04 | |
| ACCESS | Public Health Questionnaire (PHQ 9) | 90 days | 6.43 score on a scale | Standard Deviation 4.08 |
| ACCESS | Public Health Questionnaire (PHQ 9) | 60 days | 7.91 score on a scale | Standard Deviation 5.84 |
| ACCESS | Public Health Questionnaire (PHQ 9) | Baseline (upon enrollment) | 7.87 score on a scale | Standard Deviation 6.3 |
| ACCESS | Public Health Questionnaire (PHQ 9) | 28 days | 6.85 score on a scale | Standard Deviation 4.64 |
| ACCESS | Public Health Questionnaire (PHQ 9) | 14 days | 6.82 score on a scale | Standard Deviation 5.41 |
Secondary
Zarit Burden Scale
A scale that measures the level of burden on caregiver. Scale ranges from 0-28. A higher score indicates greater burden.
Time frame: Upon enrollment and 28 days
Population: Some questionnaires were not completed by the participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Zarit Burden Scale | Baseline (upon enrollment) | 8.78 score on a scale | Standard Deviation 6.05 |
| Enhanced Usual Care | Zarit Burden Scale | 28 days | 9.53 score on a scale | Standard Deviation 5.58 |
| Zarit Burden Scale | Baseline (upon enrollment) | 9.74 score on a scale | Standard Deviation 6.26 | |
| Zarit Burden Scale | 28 days | 9.79 score on a scale | Standard Deviation 4.82 | |
| ACCESS | Zarit Burden Scale | Baseline (upon enrollment) | 10.3 score on a scale | Standard Deviation 6.25 |
| ACCESS | Zarit Burden Scale | 28 days | 10.7 score on a scale | Standard Deviation 5.15 |