Trial Outcomes & Findings for A Problem Solving Intervention for Hospice Caregivers (NCT NCT03712410)
NCT ID: NCT03712410
Last Updated: 2023-02-16
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
523 participants
Primary outcome timeframe
from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)
Results posted on
2023-02-16
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
154
|
152
|
154
|
63
|
|
Overall Study
COMPLETED
|
115
|
106
|
101
|
46
|
|
Overall Study
NOT COMPLETED
|
39
|
46
|
53
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Problem Solving Intervention for Hospice Caregivers
Baseline characteristics by cohort
| Measure |
Group 1 (PISCES-f2f)
n=154 Participants
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.
|
Group 2 (PISCES Video)
n=152 Participants
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.
|
Group 3 (PISCESplus)
n=154 Participants
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.
|
Group 4 PISCESplus Online
n=63 Participants
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.
|
Total
n=523 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 17.2 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
|
Sex/Gender, Customized
Male
|
23 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
129 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
423 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Unknown or Decline to Answer
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
459 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
196 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
261 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Caregiver Generalized Anxiety Disorder (GAD-7) Score
|
6.69 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
5.74 units on a scale
STANDARD_DEVIATION 4.9 • n=7 Participants
|
6.32 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
5.85 units on a scale
STANDARD_DEVIATION 5.2 • n=4 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 5.1 • n=21 Participants
|
|
Caregiver PHQ-9 Score
|
7.54 units on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
6.99 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
6.78 units on a scale
STANDARD_DEVIATION 5.36 • n=4 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 5.5 • n=21 Participants
|
|
Caregiver Quality of Life Index (CQLI-R)
|
27.7 units on a scale
STANDARD_DEVIATION 8.0 • n=5 Participants
|
28.5 units on a scale
STANDARD_DEVIATION 8.4 • n=7 Participants
|
29.32 units on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
28.31 units on a scale
STANDARD_DEVIATION 7.7 • n=4 Participants
|
28.5 units on a scale
STANDARD_DEVIATION 7.9 • n=21 Participants
|
|
Caregiver Status
Bereaved
|
43 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Caregiver Status
Active
|
107 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
371 Participants
n=21 Participants
|
|
Caregiver Status
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Caregiver Diagnosis
Cancer
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Caregiver Diagnosis
Dementia
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Caregiver Diagnosis
Other
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
111 Participants
n=21 Participants
|
|
Caregiver Diagnosis
Unknown or Not Reported
|
103 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
360 Participants
n=21 Participants
|
|
Caregiver Dementia
No
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Caregiver Dementia
Yes
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Caregiver Dementia
Don't Know
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Caregiver Dementia
Unknown or Not Reported
|
99 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
345 Participants
n=21 Participants
|
|
Caregiver Marital Status
Single/Never Married/Partnered
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Caregiver Marital Status
Married/Partnered
|
67 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
245 Participants
n=21 Participants
|
|
Caregiver Marital Status
Widowed
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Caregiver Marital Status
Separated/Divorced
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Caregiver Marital Status
Decline to Answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Caregiver Marital Status
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Caregiver Education
Less than High School
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Caregiver Education
High School/GED
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Caregiver Education
Some College/Associate Degree
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Caregiver Education
Bachelor's Degree
|
40 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
|
Caregiver Education
Graduate/Professional Degree
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
|
Caregiver Education
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Caregiver Relation
Spouse/Partner
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Caregiver Relation
Adult Child
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
251 Participants
n=21 Participants
|
|
Caregiver Relation
Parent
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Caregiver Relation
Sibling
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Caregiver Relation
Other
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Caregiver Relation
Decline to Answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Caregiver Relation
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Care Receiver Gender
Male
|
69 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Care Receiver Gender
Female
|
75 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
269 Participants
n=21 Participants
|
|
Care Receiver Gender
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Care Receiver Ethnicity
Hispanic
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Care Receiver Ethnicity
Non-Hispanic
|
136 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
444 Participants
n=21 Participants
|
|
Care Receiver Ethnicity
Decline to Answer
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Care Receiver Ethnicity
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Care Receiver Race
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Care Receiver Race
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Care Receiver Race
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Care Receiver Race
Black or African American
|
63 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
193 Participants
n=21 Participants
|
|
Care Receiver Race
White
|
75 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
279 Participants
n=21 Participants
|
|
Care Receiver Race
More than one race
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Care Receiver Race
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Care Receiver Marital Status
Single/Never Married/Partnered
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Care Receiver Marital Status
Married/Partnered
|
57 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
198 Participants
n=21 Participants
|
|
Care Receiver Marital Status
Widowed
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Care Receiver Marital Status
Separated/Divorced
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Care Receiver Marital Status
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Care Receiver Residence
Private Home Residence/Adult Group Home
|
123 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
409 Participants
n=21 Participants
|
|
Care Receiver Residence
Assisted Living Facility/Nursing Home/Skilled Nursing Facility
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Care Receiver Residence
Other
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Care Receiver Residence
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Caregiver Distance from Receiver
With you
|
90 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
280 Participants
n=21 Participants
|
|
Caregiver Distance from Receiver
Less than 1 hour away
|
49 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Caregiver Distance from Receiver
More than 1 hour away
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Caregiver Distance from Receiver
Decline to Answer
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Caregiver Distance from Receiver
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Caregiver Time Caring
Less than 1 year
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Caregiver Time Caring
1-3 years
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Caregiver Time Caring
3 years or more
|
69 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
218 Participants
n=21 Participants
|
|
Caregiver Time Caring
Decline to Answer
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Caregiver Time Caring
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Caregiver Time Spent Caring per week
Less than 5 hours
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Caregiver Time Spent Caring per week
5-10 hours
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Caregiver Time Spent Caring per week
11-20 hours
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Caregiver Time Spent Caring per week
More than 20 hours
|
100 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
326 Participants
n=21 Participants
|
|
Caregiver Time Spent Caring per week
Decline to Answer
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Caregiver Time Spent Caring per week
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Caregiver Added Expense
Yes
|
112 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
359 Participants
n=21 Participants
|
|
Caregiver Added Expense
No
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Caregiver Added Expense
Decline to Answer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Caregiver Added Expense
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Caregiver Work Status
Yes
|
61 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Caregiver Work Status
No
|
83 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
266 Participants
n=21 Participants
|
|
Caregiver Work Status
Decline to Answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Caregiver Work Status
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Caregiver Work Support
Cut back on hours or quit work entirely
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Caregiver Work Support
Taken an unpaid leave or any leave under Family Medical Leave Act
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Caregiver Work Support
Left one job for a different one
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Caregiver Work Support
Used your own sick leave or vacation time
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Caregiver Work Support
Taken a job or worked additional hours to earn more money
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Caregiver Work Support
None of these apply
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Caregiver Work Support
Decline to Answer
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Caregiver Work Support
Selected More than 1 option
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Caregiver Work Support
Unknown or Not Reported
|
72 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
250 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)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)
Outcome measures
| Measure |
Group 1 (PISCES Face to Face)
n=154 Participants
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.
|
Group 2 (PISCES Delivered in a Hybrid Format)
n=152 Participants
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.
|
Group 3 (PISCESplus)
n=154 Participants
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.
|
Group 4 (PISCESplus Online)
n=63 Participants
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.
|
|---|---|---|---|---|
|
Table 2. Comparison of 4 Groups
Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)
|
-2.54 units on a scale
Standard Deviation 4.25
|
-1.49 units on a scale
Standard Deviation 4.06
|
-2.27 units on a scale
Standard Deviation 4.56
|
-1.52 units on a scale
Standard Deviation 5.12
|
|
Table 2. Comparison of 4 Groups
Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)
|
-2.69 units on a scale
Standard Deviation 4.29
|
-1.56 units on a scale
Standard Deviation 4.19
|
-1.87 units on a scale
Standard Deviation 4.59
|
-2.02 units on a scale
Standard Deviation 4.14
|
|
Table 2. Comparison of 4 Groups
Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)
|
1.14 units on a scale
Standard Deviation 6.42
|
0.77 units on a scale
Standard Deviation 4.82
|
0.27 units on a scale
Standard Deviation 7.17
|
1.15 units on a scale
Standard Deviation 5.80
|
PRIMARY outcome
Timeframe: 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)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
Outcome measures
| Measure |
Group 1 (PISCES Face to Face)
n=306 Participants
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.
|
Group 2 (PISCES Delivered in a Hybrid Format)
n=217 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Table 3. Comparison of Traditional PISCES vs. Online PISCES
Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)
|
-2.04 units on a scale
Standard Deviation 4.18
|
-2.03 units on a scale
Standard Deviation 4.74
|
—
|
—
|
|
Table 3. Comparison of Traditional PISCES vs. Online PISCES
Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)
|
-2.15 units on a scale
Standard Deviation 4.27
|
-1.91 units on a scale
Standard Deviation 4.44
|
—
|
—
|
|
Table 3. Comparison of Traditional PISCES vs. Online PISCES
Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)
|
0.96 units on a scale
Standard Deviation 5.70
|
0.54 units on a scale
Standard Deviation 6.76
|
—
|
—
|
PRIMARY outcome
Timeframe: from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)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
Outcome measures
| Measure |
Group 1 (PISCES Face to Face)
n=306 Participants
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.
|
Group 2 (PISCES Delivered in a Hybrid Format)
n=217 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Table 4. Within-Group Comparison Baseline vs. Follow-up
Generalised Anxiety Disorder Assessment (GAD-7)
|
-2.04 units on a scale
Standard Deviation 4.18
|
-2.03 units on a scale
Standard Deviation 4.74
|
—
|
—
|
|
Table 4. Within-Group Comparison Baseline vs. Follow-up
Patient Health Questionnaire 9 (PHQ9)
|
-2.15 units on a scale
Standard Deviation 4.27
|
-1.91 units on a scale
Standard Deviation 4.44
|
—
|
—
|
|
Table 4. Within-Group Comparison Baseline vs. Follow-up
Caregiver Quality of Life Index (CQLI-R)
|
0.96 units on a scale
Standard Deviation 5.70
|
0.54 units on a scale
Standard Deviation 6.76
|
—
|
—
|
Adverse Events
Group 1 (PISCES-f2f)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (PISCES Video)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 (PISCESplus)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4 PISCESplus Online
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place