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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR012213 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Hospice care is conceptualized as quality compassionate care for people facing a life-limiting illness, with services that cover clinical care, pain management, and emotional and spiritual support tailored to patients' and families' needs and preferences. Family members, spouses, friends or others who assume the unpaid or informal caregiving role are essential to the delivery of hospice services; however, stress and caregiver burden can negatively affect caregivers' morbidity and mortality. The emotional needs of individuals caring for dying persons at home are not well attended, and interventions aiming to provide support to hospice caregivers are notably lacking. The investigator team recently completed a study with 514 hospice caregivers to test a problem-solving therapy (PST) intervention tailored specifically for the hospice setting, entitled PISCES (Problem-solving Intervention to Support Caregivers in End of Life care Settings). The findings demonstrate that the PISCES intervention when delivered face to face was effective leading to statistically significant decrease in anxiety and increase in quality of life when compared to the other groups (video group and attention control). An additional lesson learned from that RCT study was that caregivers wanted to focus not only on specific problems or challenges, but also on recognizing the positive aspects of caregiving. This approach of positive reappraisal has been found to enhance problem solving interventions in other settings. The specific aims of this new study are: 1) to compare the effectiveness of the PISCES intervention when delivered face to face and when delivered in a hybrid platform (with the first session in person and remaining sessions via video) to hospice caregivers; 2) to compare the effectiveness of the PISCES intervention to the refined PISCES intervention (PISCESplus) that integrates positive reappraisal elements; 3) to assess caregivers' perceptions of and satisfaction with the PISCESplus intervention; and 4) to conduct a cost analysis of the three intervention groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (PISCES face to face) | Active Comparator | Family caregivers will receive three sessions of the PISCES intervention in person. The agenda for the first face to face visit for caregivers (suggested timeline 5-7 days after hospice admission) includes an explanation of the purpose of the visit/call. During the first session, the interventionist works on steps one and two of the ADAPT model, namely "Attitude" and "Defining the Problem and Setting Realistic Goals." During the second visit (suggested timeline 11-13 days after hospice admission) the interventionist covers steps three and four of the ADAPT model. Step three encourages caregivers in being creative and generating alternative solutions. Step four focuses on predicting the consequences and developing a solution plan. The third visit (suggested timeline 16-18 days after hospice admission) focuses on step five, namely trying out the solution plan and determining if it works. |
|
| Group 2 (PISCES delivered in a hybrid format) | Experimental | In this group, participants will receive the PISCES intervention in three sessions; however, the first session will be delivered face to face and the other two via video. The three intervention sessions will be scheduled with a suggested timeline between days 5 and 18 of the hospice admission. The first session will take place in person (suggested timeline 5-7 days after hospice admission). After the first session where the in-person encounter will allow for the establishment of rapport between the interventionist and the caregiver, the second session (suggested timeline 11-13 days after hospice admission) and the third session (suggested timeline 16-18 days after hospice admissions) will be conducted via live videoconferencing. If the caregiver already has access to a computer and Internet, they will utilize the videoconferencing solution. If videoconferencing is not feasible, the sessions will be delivered over the regular phone. |
|
| Group 3 (PISCESplus) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PISCES | Behavioral | The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Table 2. Comparison of 4 Groups | Comparison of 4 groups Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more anxiety) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome (more distress) Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome (better quality of life) | from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30) |
| Table 3. Comparison of Traditional PISCES vs. Online PISCES | Comparison of Traditional PISCES vs. Online PISCES Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome | from baseline to follow-up (time point 1 is pre-intervention, i.e., day 0 and time point 2 is post-intervention, approx. day 30) |
| Table 4. Within-Group Comparison Baseline vs. Follow-up | Within-Group Comparison Baseline vs. Follow-up Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome | from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30) |
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Inclusion Criteria:
Exclusion Criteria:
The investigator's inclusion criteria cover all genders (and gender is based on self-representation of gender identity).
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| Name | Affiliation | Role |
|---|---|---|
| George Demiris, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39985289 | Derived | Oh O, Oliver DP, Washington K, Demiris G. When Is the Best Time to Deliver Supportive Interventions to Hospice Family Caregivers? A Multi-Method Study. Gerontologist. 2025 Apr 9;65(5):gnaf085. doi: 10.1093/geront/gnaf085. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (PISCES-f2f) | Family caregivers will receive three sessions of the PISCES intervention in person. The agenda for the first face to face visit for caregivers (suggested timeline 5-7 days after hospice admission) includes an explanation of the purpose of the visit/call. During the first session, the interventionist works on steps one and two of the ADAPT model, namely "Attitude" and "Defining the Problem and Setting Realistic Goals." During the second visit (suggested timeline 11-13 days after hospice admission) the interventionist covers steps three and four of the ADAPT model. Step three encourages caregivers in being creative and generating alternative solutions. Step four focuses on predicting the consequences and developing a solution plan. The third visit (suggested timeline 16-18 days after hospice admission) focuses on step five, namely trying out the solution plan and determining if it works. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
| FG001 | Group 2 (PISCES Video) | In this group, participants will receive the PISCES intervention in three sessions; however, the first session will be delivered face to face and the other two via video or phone. The three intervention sessions will be scheduled with a suggested timeline between days 5 and 18 of the hospice admission. The first session will take place in person (suggested timeline 5-7 days after hospice admission). After the first session where the in-person encounter will allow for the establishment of rapport between the interventionist and the caregiver, the second session (suggested timeline 11-13 days after hospice admission) and the third session (suggested timeline 16-18 days after hospice admissions) will be conducted via live videoconferencing. If the caregiver already has access to a computer and Internet, they will utilize the videoconferencing solution. If videoconferencing is not feasible, the sessions will be delivered over the regular phone. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
| FG002 | Group 3 (PISCESplus) | PISCESplus is meant to be an enhanced version of the PISCES intervention including the original problem solving therapy modules with the addition of positive reappraisal elements. The suggested timeline for the first session which will be in person is 5-7 days after hospice admission. At the end of the first session, the interventionist will ask the caregiver to take the time to think about and identify some positive aspects of caregiving. At the end of the second session (which is scheduled to take place via video approx. 11-13 days after admission) the interventionist will ask the caregiver to go over the benefits or positive aspects of caregiving that they had identified and ask them to comment as to why they perceive these as positive or beneficial. The third session will also take place via video. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
| FG003 | Group 4 PISCESplus Online | In this group, participants receive the entire intervention (PISCES plus-so the PISCES intervention with the positive reappraisal enhancements) online and complete all surveys electronically. All pre-and post assessments are conducted online and the PISCES sessions are carried out online as well. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants were randomly assigned to each of these groups. They reported baseline demographics upon consenting to participate in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (PISCES-f2f) | Family caregivers will receive three sessions of the PISCES intervention in person. The agenda for the first face to face visit for caregivers (suggested timeline 5-7 days after hospice admission) includes an explanation of the purpose of the visit/call. During the first session, the interventionist works on steps one and two of the ADAPT model, namely "Attitude" and "Defining the Problem and Setting Realistic Goals." During the second visit (suggested timeline 11-13 days after hospice admission) the interventionist covers steps three and four of the ADAPT model. Step three encourages caregivers in being creative and generating alternative solutions. Step four focuses on predicting the consequences and developing a solution plan. The third visit (suggested timeline 16-18 days after hospice admission) focuses on step five, namely trying out the solution plan and determining if it works. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
| 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 | Table 2. Comparison of 4 Groups | Comparison of 4 groups Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more anxiety) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome (more distress) Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome (better quality of life) | Posted | Mean | Standard Deviation | units on a scale | from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30) |
|
Adverse event data were collected over the duration of an individual participant's time in the study (which ranged from 4 to 6 weeks).
Given that our intervention was a behavioral intervention with minimal risks. Our definition of adverse event and/or serious adverse event aligns with that of the clinicaltrials.gov Definition.
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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 | Group 1 (PISCES-f2f) | Family caregivers will receive three sessions of the PISCES intervention in person. The agenda for the first face to face visit for caregivers (suggested timeline 5-7 days after hospice admission) includes an explanation of the purpose of the visit/call. During the first session, the interventionist works on steps one and two of the ADAPT model, namely "Attitude" and "Defining the Problem and Setting Realistic Goals." During the second visit (suggested timeline 11-13 days after hospice admission) the interventionist covers steps three and four of the ADAPT model. Step three encourages caregivers in being creative and generating alternative solutions. Step four focuses on predicting the consequences and developing a solution plan. The third visit (suggested timeline 16-18 days after hospice admission) focuses on step five, namely trying out the solution plan and determining if it works. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
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Because of the COVID pandemic we implemented some changes in the study protocol for each group and converted data collection to online questionnaires.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Demiris | University of Pennsylvania | 2158988559 | gdemiris@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2022 | Jan 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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PISCESplus is meant to be an enhanced version of the PISCES intervention including the original problem solving therapy modules with the addition of positive reappraisal elements. The suggested timeline for the first session which will be in person is 5-7 days after hospice admission. At the end of the first session, the interventionist will ask the caregiver to take the time to think about and identify some positive aspects of caregiving. At the end of the second session (which is scheduled to take place via video approx. 11-13 days after admission) the interventionist will ask the caregiver to go over the benefits or positive aspects of caregiving that they had identified and ask them to comment as to why they perceive these as positive or beneficial. The third session will also take place via video. |
|
| Group 4 (PISCESplus online) | Experimental | Participants in this group receive the PISCES plus intervention (the PISCES intervention with the enhancement of the positive reappraisal elements) delivered fully online. All assessments and sessions take place online. |
|
| BG001 | Group 2 (PISCES Video) | In this group, participants will receive the PISCES intervention in three sessions; however, the first session will be delivered face to face and the other two via video or phone. The three intervention sessions will be scheduled with a suggested timeline between days 5 and 18 of the hospice admission. The first session will take place in person (suggested timeline 5-7 days after hospice admission). After the first session where the in-person encounter will allow for the establishment of rapport between the interventionist and the caregiver, the second session (suggested timeline 11-13 days after hospice admission) and the third session (suggested timeline 16-18 days after hospice admissions) will be conducted via live videoconferencing. If the caregiver already has access to a computer and Internet, they will utilize the videoconferencing solution. If videoconferencing is not feasible, the sessions will be delivered over the regular phone. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
| BG002 | Group 3 (PISCESplus) | PISCESplus is meant to be an enhanced version of the PISCES intervention including the original problem solving therapy modules with the addition of positive reappraisal elements. The suggested timeline for the first session which will be in person is 5-7 days after hospice admission. At the end of the first session, the interventionist will ask the caregiver to take the time to think about and identify some positive aspects of caregiving. At the end of the second session (which is scheduled to take place via video approx. 11-13 days after admission) the interventionist will ask the caregiver to go over the benefits or positive aspects of caregiving that they had identified and ask them to comment as to why they perceive these as positive or beneficial. The third session will also take place via video. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
| BG003 | Group 4 PISCESplus Online | In this group, participants receive the entire intervention (PISCES plus-so the PISCES intervention with the positive reappraisal enhancements) online and complete all surveys electronically. All pre-and post assessments are conducted online and the PISCES sessions are carried out online as well. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Caregiver Generalized Anxiety Disorder (GAD-7) Score | Mean | Standard Deviation | units on a scale |
|
| Caregiver PHQ-9 Score | Mean | Standard Deviation | units on a scale |
|
| Caregiver Quality of Life Index (CQLI-R) | Mean | Standard Deviation | units on a scale |
|
| Caregiver Status | Count of Participants | Participants |
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| Caregiver Diagnosis | Count of Participants | Participants |
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| Caregiver Dementia | Count of Participants | Participants |
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| Caregiver Marital Status | Count of Participants | Participants |
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| Caregiver Education | Count of Participants | Participants |
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| Caregiver Relation | Count of Participants | Participants |
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| Care Receiver Gender | Count of Participants | Participants |
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| Care Receiver Ethnicity | Count of Participants | Participants |
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| Care Receiver Race | Count of Participants | Participants |
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| Care Receiver Marital Status | Count of Participants | Participants |
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| Care Receiver Residence | Count of Participants | Participants |
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| Caregiver Distance from Receiver | Count of Participants | Participants |
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| Caregiver Time Caring | Count of Participants | Participants |
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| Caregiver Time Spent Caring per week | Count of Participants | Participants |
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| Caregiver Added Expense | Count of Participants | Participants |
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| Caregiver Work Status | Count of Participants | Participants |
|
| Caregiver Work Support | Count of Participants | Participants |
|
| OG001 | Group 2 (PISCES Delivered in a Hybrid Format) | In this group, participants will receive the PISCES intervention in three sessions; however, the first session will be delivered face to face and the other two via video. The three intervention sessions will be scheduled with a suggested timeline between days 5 and 18 of the hospice admission. The first session will take place in person (suggested timeline 5-7 days after hospice admission). After the first session where the in-person encounter will allow for the establishment of rapport between the interventionist and the caregiver, the second session (suggested timeline 11-13 days after hospice admission) and the third session (suggested timeline 16-18 days after hospice admissions) will be conducted via live videoconferencing. If the caregiver already has access to a computer and Internet, they will utilize the videoconferencing solution. If videoconferencing is not feasible, the sessions will be delivered over the regular phone. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
| OG002 | Group 3 (PISCESplus) | PISCESplus is meant to be an enhanced version of the PISCES intervention including the original problem solving therapy modules with the addition of positive reappraisal elements. The suggested timeline for the first session which will be in person is 5-7 days after hospice admission. At the end of the first session, the interventionist will ask the caregiver to take the time to think about and identify some positive aspects of caregiving. At the end of the second session (which is scheduled to take place via video approx. 11-13 days after admission) the interventionist will ask the caregiver to go over the benefits or positive aspects of caregiving that they had identified and ask them to comment as to why they perceive these as positive or beneficial. The third session will also take place via video. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
| OG003 | Group 4 (PISCESplus Online) | Participants in this group receive the PISCES plus intervention (the PISCES intervention with the enhancement of the positive reappraisal elements) delivered fully online. All assessments and sessions take place online. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. |
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|
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| Primary | Table 3. Comparison of Traditional PISCES vs. Online PISCES | Comparison of Traditional PISCES vs. Online PISCES Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome | Posted | Mean | Standard Deviation | units on a scale | from baseline to follow-up (time point 1 is pre-intervention, i.e., day 0 and time point 2 is post-intervention, approx. day 30) |
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|
|
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| Primary | Table 4. Within-Group Comparison Baseline vs. Follow-up | Within-Group Comparison Baseline vs. Follow-up Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems) Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome | Posted | Mean | Standard Deviation | units on a scale | from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30) |
|
|
|
|
| 0 |
| 154 |
| 0 |
| 154 |
| 0 |
| 154 |
| EG001 | Group 2 (PISCES Video) | In this group, participants will receive the PISCES intervention in three sessions; however, the first session will be delivered face to face and the other two via video or phone. The three intervention sessions will be scheduled with a suggested timeline between days 5 and 18 of the hospice admission. The first session will take place in person (suggested timeline 5-7 days after hospice admission). After the first session where the in-person encounter will allow for the establishment of rapport between the interventionist and the caregiver, the second session (suggested timeline 11-13 days after hospice admission) and the third session (suggested timeline 16-18 days after hospice admissions) will be conducted via live videoconferencing. If the caregiver already has access to a computer and Internet, they will utilize the videoconferencing solution. If videoconferencing is not feasible, the sessions will be delivered over the regular phone. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. | 0 | 152 | 0 | 152 | 0 | 152 |
| EG002 | Group 3 (PISCESplus) | PISCESplus is meant to be an enhanced version of the PISCES intervention including the original problem solving therapy modules with the addition of positive reappraisal elements. The suggested timeline for the first session which will be in person is 5-7 days after hospice admission. At the end of the first session, the interventionist will ask the caregiver to take the time to think about and identify some positive aspects of caregiving. At the end of the second session (which is scheduled to take place via video approx. 11-13 days after admission) the interventionist will ask the caregiver to go over the benefits or positive aspects of caregiving that they had identified and ask them to comment as to why they perceive these as positive or beneficial. The third session will also take place via video. PISCES: The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. | 0 | 154 | 0 | 154 | 0 | 154 |
| EG003 | Group 4 PISCESplus Online | In this group, participants receive the entire intervention (PISCES plus-so the PISCES intervention with the positive reappraisal enhancements) online and complete all surveys electronically. All pre-and post assessments are conducted online and the PISCES sessions are carried out online as well. | 0 | 63 | 0 | 63 | 0 | 63 |
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| Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R) |
|
| 0.9848 |
p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9) |
| Other |
Group Comparisons |
| Wilcoxon (Mann-Whitney) | 0.9169 | p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R) | Other | Group Comparisons |
| Caregiver Quality of Life Index (CQLI-R) |
|
| <0.0001 |
p-value for Patient Health Questionnaire 9 (PHQ9) for arm Traditional PISCES |
| Other |
Group Comparisons |
| Wilcoxon Signed Rank Test | 0.0155 | p-value for Caregiver Quality of Life Index (CQLI-R) for arm Traditional PISCES | Other | Group Comparisons |
| Wilcoxon Signed Rank Test | <0.0001 | p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Online PISCES | Other | Group Comparisons |
| Wilcoxon Signed Rank Test | <0.0001 | p-value for Patient Health Questionnaire 9 (PHQ9) for arm Online PISCES | Other | Group Comparisons |
| Wilcoxon Signed Rank Test | 0.0504 | p-value for Caregiver Quality of Life Index (CQLI-R) for arm Online PISCES | Other | Group Comparisons |