Trial Outcomes & Findings for The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice (NCT NCT04869085)
NCT ID: NCT04869085
Last Updated: 2026-03-11
Results Overview
At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: Worst pain and average pain in past 7 days scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
Baseline to 2-weeks post baseline
Results posted on
2026-03-11
Participant Flow
Participant milestones
| Measure |
e-PainSupport Condition
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
|
Standard Care Condition
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
42
|
|
Overall Study
Patient Started
|
23
|
21
|
|
Overall Study
Caregiver Started
|
23
|
21
|
|
Overall Study
COMPLETED
|
36
|
40
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
| Measure |
e-PainSupport Condition
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
|
Standard Care Condition
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
|
|---|---|---|
|
Overall Study
Death
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
Baseline Characteristics
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
Baseline characteristics by cohort
| Measure |
e-PainSupport Condition
n=46 Participants
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
|
Standard Care Condition
n=42 Participants
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Patient demographics · <=18 years
|
0 Participants
n=23 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=44 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Age, Categorical
Patient demographics · Between 18 and 65 years
|
4 Participants
n=23 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
5 Participants
n=21 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
9 Participants
n=44 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Age, Categorical
Patient demographics · >=65 years
|
19 Participants
n=23 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
16 Participants
n=21 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
35 Participants
n=44 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Age, Categorical
Caregiver demographics · <=18 years
|
0 Participants
n=23 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=44 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Age, Categorical
Caregiver demographics · Between 18 and 65 years
|
18 Participants
n=23 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
16 Participants
n=21 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
34 Participants
n=44 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Age, Categorical
Caregiver demographics · >=65 years
|
5 Participants
n=23 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
5 Participants
n=21 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
10 Participants
n=44 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Age, Continuous
Patient participant age
|
72.65 years
STANDARD_DEVIATION 13.84 • n=23 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
75.67 years
STANDARD_DEVIATION 13.01 • n=21 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
74.09 years
STANDARD_DEVIATION 13.38 • n=44 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Age, Continuous
Caregiver participant age
|
53.27 years
STANDARD_DEVIATION 13.17 • n=23 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
57.24 years
STANDARD_DEVIATION 11.69 • n=21 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
55.21 years
STANDARD_DEVIATION 12.48 • n=44 Participants • Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Sex: Female, Male
Patient gender · Female
|
13 Participants
n=23 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
10 Participants
n=21 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
23 Participants
n=44 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
|
Sex: Female, Male
Patient gender · Male
|
10 Participants
n=23 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
11 Participants
n=21 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
21 Participants
n=44 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
|
Sex: Female, Male
Caregiver gender · Female
|
18 Participants
n=23 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
15 Participants
n=21 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
33 Participants
n=44 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
|
Sex: Female, Male
Caregiver gender · Male
|
5 Participants
n=23 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
6 Participants
n=21 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
11 Participants
n=44 Participants • There were 44 caregivers who responded. There were 44 patients who responded.
|
|
Ethnicity (NIH/OMB)
Patient Ethnicity · Hispanic or Latino
|
1 Participants
n=23 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
0 Participants
n=21 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
1 Participants
n=44 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
|
Ethnicity (NIH/OMB)
Patient Ethnicity · Not Hispanic or Latino
|
22 Participants
n=23 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
21 Participants
n=21 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
43 Participants
n=44 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
|
Ethnicity (NIH/OMB)
Patient Ethnicity · Unknown or Not Reported
|
0 Participants
n=23 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
0 Participants
n=21 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
0 Participants
n=44 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
|
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Hispanic or Latino
|
3 Participants
n=23 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
1 Participants
n=21 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
4 Participants
n=44 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
|
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Not Hispanic or Latino
|
20 Participants
n=23 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
20 Participants
n=21 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
40 Participants
n=44 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
|
Ethnicity (NIH/OMB)
Caregiver Ethnicity · Unknown or Not Reported
|
0 Participants
n=23 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
0 Participants
n=21 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
0 Participants
n=44 Participants • The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs)
|
|
Race (NIH/OMB)
Patient participants · American Indian or Alaska Native
|
1 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
1 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Patient participants · Asian
|
3 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
1 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
4 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Patient participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Patient participants · Black or African American
|
5 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
3 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
8 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Patient participants · White
|
14 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
17 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
31 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Patient participants · More than one race
|
0 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Patient participants · Unknown or Not Reported
|
0 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Caregiver participants · American Indian or Alaska Native
|
1 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
1 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Region of Enrollment
United States · Caregivers
|
23 Participants
n=46 Participants
|
21 Participants
n=42 Participants
|
44 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Caregiver participants · Asian
|
3 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
1 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
4 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Caregiver participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Caregiver participants · Black or African American
|
5 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
2 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
7 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Caregiver participants · White
|
14 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
17 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
31 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Caregiver participants · More than one race
|
0 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
0 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Race (NIH/OMB)
Caregiver participants · Unknown or Not Reported
|
0 Participants
n=23 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
1 Participants
n=21 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
1 Participants
n=44 Participants • Measure Analysis Population Description: Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs).
|
|
Region of Enrollment
United States · Patients
|
23 Participants
n=46 Participants
|
21 Participants
n=42 Participants
|
44 Participants
n=88 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2-weeks post baselinePopulation: A total of 44 patients and 44 caregivers participated in the study. The outcome was measured only in patients (n=44). Among these patients, 23 were in the intervention condition (e-PainSupport) and 21 were in the standard care condition. Of the 23 patients in the intervention condition, only 20 completed the measure. In the standard care condition, 16 out of the 21 patients completed the measure.
At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: Worst pain and average pain in past 7 days scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity.
Outcome measures
| Measure |
e-PainSupport Condition
n=20 Participants
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
|
Standard Care Condition
n=16 Participants
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
|
|---|---|---|
|
Minimally Important Clinical Change in Worst Pain Intensity
Worst pain improvement
|
4 Participants
|
2 Participants
|
|
Minimally Important Clinical Change in Worst Pain Intensity
Worst pain unimproved
|
16 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2-weeks post baselinePopulation: A total of 88 patients and caregivers participated in the study. This outcome was only measured in patients (n=44). A total of 23 were in the intervention and 21 were in the standard care condition. Of 23, only 16 completed this measure in the e-PainSupport condition and of 21, only 18 completed in the standard care condition.
At Least 20 Percent Change on the PROMIS Average Pain Scale. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: Average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity.
Outcome measures
| Measure |
e-PainSupport Condition
n=16 Participants
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
|
Standard Care Condition
n=18 Participants
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
|
|---|---|---|
|
Minimally Important Clinical Change in Average Pain Intensity
Improved average pain
|
3 Participants
|
1 Participants
|
|
Minimally Important Clinical Change in Average Pain Intensity
Unimproved average pain
|
13 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2-weeks post baselinePopulation: A total of 88 patients and caregivers participated in the study. This outcome was only measured in patients (n=44). A total of 23 were in the intervention and 21 were in the standard care condition. Of 23, only 16 completed this measure in the e-PainSupport condition and of 21, only 20 completed in the standard care condition.
At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity.
Outcome measures
| Measure |
e-PainSupport Condition
n=16 Participants
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
|
Standard Care Condition
n=20 Participants
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
|
|---|---|---|
|
Minimally Important Clinical Change in Current Pain Intensity
Pain now unimproved
|
13 Participants
|
18 Participants
|
|
Minimally Important Clinical Change in Current Pain Intensity
Pain now improvement
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to 2-weeks post baselinePatient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0. 3items: worst pain and average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity.
Outcome measures
| Measure |
e-PainSupport Condition
n=23 Participants
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
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Standard Care Condition
n=21 Participants
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
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Change in the Continuous Score of the Pain Intensity Scale
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5.89 units on a scale
Standard Deviation 17.14
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1.59 units on a scale
Standard Deviation 14.88
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 2-weeks post baselineChronic Pain Self-Efficacy Scale and the two weeks post baseline: Self-efficacy for pain management subscale measures confidence in managing pain, 5 items on 10-point Likert scale anchored on the ends by 10=very uncertain and 100=very certain. The score ranges from 50 to 500. Higher scores indicate higher perceived self efficacy.
Outcome measures
| Measure |
e-PainSupport Condition
n=23 Participants
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
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Standard Care Condition
n=21 Participants
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
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|---|---|---|
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Caregiver Self-efficacy: Difference in Self-efficacy Scores From Baseline to 14 Days
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-2.87 units on a scale
Standard Deviation 24.77
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-0.38 units on a scale
Standard Deviation 18.75
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 2-weeks post baselineMorisky Medication Adherence Scale-4 item version: Measures medication adherence, 4 items on a five-point Likert scale. Patients answer yes or no to questions (e.g., Do you sometimes forget to take your pain medication?).Each "yes" answer is scored as 1.The score ranges from 0 to 4. Lower score indicates better adherence.
Outcome measures
| Measure |
e-PainSupport Condition
n=23 Participants
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
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Standard Care Condition
n=21 Participants
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
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|---|---|---|
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Adherence to Pain Management: Difference in Change Scores From Baseline to 14 Days
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0.22 units on a scale
Standard Deviation 0.52
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-0.24 units on a scale
Standard Deviation 0.43
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 2-weeks post baselineBarriers Questionnaire II measures 8 knowledge barriers about reporting pain and using analgesics, with four subscales (physiological effects, 12 items; fatalism, 3 items; communication, 6 items; and harmful effects, 6 items (total 27 items) on a 6-point scale (0 = don't agree, 5 = agree very much), items averaged (range 0 to 5). The score ranges from 0-135. Higher scores indicate stronger barriers.
Outcome measures
| Measure |
e-PainSupport Condition
n=23 Participants
e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.
e-PainSupport: Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
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Standard Care Condition
n=21 Participants
Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.
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Family Caregiver Knowledge: Difference in Change Scores From Baseline to 14 Days
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-0.27 units on a scale
Standard Deviation 1.01
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-0.21 units on a scale
Standard Deviation 0.83
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Adverse Events
e-PainSupport Condition- Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Standard Care Condition-- Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 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