Trial Outcomes & Findings for Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial (NCT NCT04561765)
NCT ID: NCT04561765
Last Updated: 2025-03-30
Results Overview
Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
through the completion of the study, on average 4 months.
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
iCanCope
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
40
|
|
Overall Study
COMPLETED
|
38
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
one participant had missing data from each group
Baseline characteristics by cohort
| Measure |
iCanCope
n=40 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=42 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=40 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 12.9 • n=40 Participants
|
40.9 years
STANDARD_DEVIATION 13.2 • n=42 Participants
|
45.6 years
STANDARD_DEVIATION 10.5 • n=40 Participants
|
42.4 years
STANDARD_DEVIATION 12.6 • n=122 Participants
|
|
Sex/Gender, Customized
Female
|
27 Participants
n=40 Participants
|
30 Participants
n=42 Participants
|
28 Participants
n=40 Participants
|
85 Participants
n=122 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=40 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=40 Participants
|
36 Participants
n=122 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=40 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan
|
0 Participants
n=40 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=40 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=40 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=40 Participants
|
10 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=40 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=40 Participants
|
9 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=40 Participants
|
33 Participants
n=42 Participants
|
32 Participants
n=40 Participants
|
99 Participants
n=122 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=40 Participants
|
42 participants
n=42 Participants
|
40 participants
n=40 Participants
|
122 participants
n=122 Participants
|
|
Marital Status
Divorced
|
3 Participants
n=40 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=40 Participants
|
9 Participants
n=122 Participants
|
|
Marital Status
Married
|
13 Participants
n=40 Participants
|
15 Participants
n=42 Participants
|
20 Participants
n=40 Participants
|
48 Participants
n=122 Participants
|
|
Marital Status
Other
|
0 Participants
n=40 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=122 Participants
|
|
Marital Status
Seperated
|
2 Participants
n=40 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=122 Participants
|
|
Marital Status
Single
|
20 Participants
n=40 Participants
|
22 Participants
n=42 Participants
|
17 Participants
n=40 Participants
|
59 Participants
n=122 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=40 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=122 Participants
|
|
Marital Status
MIssing
|
1 Participants
n=40 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=122 Participants
|
|
Degree
Advanced
|
4 Participants
n=40 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=40 Participants
|
13 Participants
n=122 Participants
|
|
Degree
Associates
|
9 Participants
n=40 Participants
|
8 Participants
n=42 Participants
|
3 Participants
n=40 Participants
|
20 Participants
n=122 Participants
|
|
Degree
Bachelors
|
10 Participants
n=40 Participants
|
13 Participants
n=42 Participants
|
9 Participants
n=40 Participants
|
32 Participants
n=122 Participants
|
|
Degree
High School or GED
|
10 Participants
n=40 Participants
|
7 Participants
n=42 Participants
|
11 Participants
n=40 Participants
|
28 Participants
n=122 Participants
|
|
Degree
Some college
|
6 Participants
n=40 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=40 Participants
|
21 Participants
n=122 Participants
|
|
Degree
Technical schooling
|
1 Participants
n=40 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=40 Participants
|
6 Participants
n=122 Participants
|
|
Degree
Missing
|
0 Participants
n=40 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=122 Participants
|
|
Age at Diagnosis
|
11.7 years
STANDARD_DEVIATION 13.1 • n=39 Participants • one participant had missing data from each group
|
10.3 years
STANDARD_DEVIATION 11.8 • n=41 Participants • one participant had missing data from each group
|
11.5 years
STANDARD_DEVIATION 12.2 • n=39 Participants • one participant had missing data from each group
|
11.2 years
STANDARD_DEVIATION 12.3 • n=119 Participants • one participant had missing data from each group
|
|
Surgeries
0
|
7 Participants
n=40 Participants • Collected fom completers
|
5 Participants
n=42 Participants • Collected fom completers
|
6 Participants
n=40 Participants • Collected fom completers
|
18 Participants
n=122 Participants • Collected fom completers
|
|
Surgeries
1 to 3
|
14 Participants
n=40 Participants • Collected fom completers
|
17 Participants
n=42 Participants • Collected fom completers
|
12 Participants
n=40 Participants • Collected fom completers
|
43 Participants
n=122 Participants • Collected fom completers
|
|
Surgeries
4 to 6
|
5 Participants
n=40 Participants • Collected fom completers
|
3 Participants
n=42 Participants • Collected fom completers
|
6 Participants
n=40 Participants • Collected fom completers
|
14 Participants
n=122 Participants • Collected fom completers
|
|
Surgeries
7 to 10
|
2 Participants
n=40 Participants • Collected fom completers
|
3 Participants
n=42 Participants • Collected fom completers
|
5 Participants
n=40 Participants • Collected fom completers
|
10 Participants
n=122 Participants • Collected fom completers
|
|
Surgeries
11 or more
|
10 Participants
n=40 Participants • Collected fom completers
|
8 Participants
n=42 Participants • Collected fom completers
|
5 Participants
n=40 Participants • Collected fom completers
|
23 Participants
n=122 Participants • Collected fom completers
|
|
Surgeries
Unknown or missing
|
2 Participants
n=40 Participants • Collected fom completers
|
6 Participants
n=42 Participants • Collected fom completers
|
6 Participants
n=40 Participants • Collected fom completers
|
14 Participants
n=122 Participants • Collected fom completers
|
|
Parents
Yes
|
13 Participants
n=40 Participants
|
14 Participants
n=42 Participants
|
22 Participants
n=40 Participants
|
49 Participants
n=122 Participants
|
|
Parents
No
|
20 Participants
n=40 Participants
|
24 Participants
n=42 Participants
|
17 Participants
n=40 Participants
|
61 Participants
n=122 Participants
|
|
Parents
Maybe
|
7 Participants
n=40 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=40 Participants
|
12 Participants
n=122 Participants
|
|
Children
Yes
|
11 Participants
n=40 Participants
|
10 Participants
n=42 Participants
|
13 Participants
n=40 Participants
|
34 Participants
n=122 Participants
|
|
Children
No
|
9 Participants
n=40 Participants
|
11 Participants
n=42 Participants
|
10 Participants
n=40 Participants
|
30 Participants
n=122 Participants
|
|
Children
Maybe
|
1 Participants
n=40 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=122 Participants
|
|
Children
Missing
|
19 Participants
n=40 Participants
|
20 Participants
n=42 Participants
|
15 Participants
n=40 Participants
|
54 Participants
n=122 Participants
|
PRIMARY outcome
Timeframe: through the completion of the study, on average 4 months.Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Engagement Activity
|
4.7 minutes per day
Standard Deviation 3.9
|
8.1 minutes per day
Standard Deviation 6.5
|
—
|
PRIMARY outcome
Timeframe: through the completion of the study, on average 4 months.A comparison within groups change of pain severity measured by the Brief Pain Inventory-Short Form. Respondents rate items on a 0-10 scale to indicate the pain severity and interference, and the total score is the mean of each subfactor. The higher the score indicates more severity and interference of pain.
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=34 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Pain Severity
Intake (Baseline)
|
4.743 score on a scale
Standard Deviation 1.83
|
4.625 score on a scale
Standard Deviation 2.17
|
4.787 score on a scale
Standard Deviation 2.15
|
|
Pain Severity
Discharge (about 2 weeks)
|
4.164 score on a scale
Standard Deviation 1.99
|
3.778 score on a scale
Standard Deviation 2.48
|
4.875 score on a scale
Standard Deviation 2.65
|
|
Pain Severity
Follow-Up (on average 4 months)
|
4.439 score on a scale
Standard Deviation 2.01
|
4.160 score on a scale
Standard Deviation 2.44
|
4.375 score on a scale
Standard Deviation 2.47
|
PRIMARY outcome
Timeframe: through the completion of the study, on average 4 months.A comparison within groups change of pain interference measured by the Pain Interference Index Scale. Respondents rate items on a 0-6 scale to indicate how much pain has interfered with various activities, and the total score is the mean of the six items. Where 6 indicates high interference. Presented here are the non-linear converted T scores with a 'population' mean of 50 and standard deviation of 10. Scores above 50 indicate more pain interference.
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=34 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Pain Interference Index
Intake (Baseline)
|
57.709 T-score
Standard Deviation 8.68
|
58.666 T-score
Standard Deviation 7.92
|
59.394 T-score
Standard Deviation 7.41
|
|
Pain Interference Index
Discharge (an average of 2 weeks)
|
57.033 T-score
Standard Deviation 7.45
|
54.965 T-score
Standard Deviation 7.78
|
60.210 T-score
Standard Deviation 9.21
|
|
Pain Interference Index
Follow-Up (on average 4 months)
|
57.783 T-score
Standard Deviation 8.04
|
56.366 T-score
Standard Deviation 9.47
|
59.424 T-score
Standard Deviation 9.73
|
SECONDARY outcome
Timeframe: through the completion of the study, on average 4 months.Population: This outcome was collected aggregately to evaluate feasibility of the mobile application and to assess for generalized acceptability of the mobile application. Due to this, the results were not looked at per arm but together to assess overall qualitative themes.
What are perceptions of satisfaction across groups exposed to the iCanCope mobile application using an The Treatment Services Review (TSR). Data presented here represents the themes that emerged from the qualitative interviews.
Outcome measures
| Measure |
iCanCope
n=82 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Treatment Services Review
User experience
|
46 themes
|
—
|
—
|
|
Treatment Services Review
Check-ins
|
29 themes
|
—
|
—
|
|
Treatment Services Review
Profile set up
|
5 themes
|
—
|
—
|
|
Treatment Services Review
Articles presented to the user by program
|
40 themes
|
—
|
—
|
|
Treatment Services Review
Trends presented to the user by the program
|
27 themes
|
—
|
—
|
|
Treatment Services Review
Goals presented to the user by the program
|
37 themes
|
—
|
—
|
|
Treatment Services Review
Improvement suggestions
|
40 themes
|
—
|
—
|
|
Treatment Services Review
Liked most
|
36 themes
|
—
|
—
|
|
Treatment Services Review
Liked least
|
25 themes
|
—
|
—
|
SECONDARY outcome
Timeframe: through the completion of the study, on average 4 months.A comparison within change of generalized anxiety measured by the generalized anxiety disorder scale (GAD-7). After reading each statement, one of four choices are provided and respondents can select one response (1=not at all sure, 2=several days, 3=over half days, 4=nearly every day). Each column is then added, and a total score is obtained, with scores falling into four levels of anxiety, including minimal (1-4), mild (5-9), moderate (10-14), and severe (15-21)
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=34 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Anxiety
Intake (Baseline)
|
7.865 score on a scale
Standard Deviation 5.21
|
7.457 score on a scale
Standard Deviation 4.56
|
8.412 score on a scale
Standard Deviation 6.16
|
|
Anxiety
Discharge (an average of 2 weeks)
|
7.432 score on a scale
Standard Deviation 5.24
|
5.667 score on a scale
Standard Deviation 3.65
|
8.871 score on a scale
Standard Deviation 6.48
|
|
Anxiety
Follow-Up (on average 4 months)
|
6.889 score on a scale
Standard Deviation 4.77
|
6.861 score on a scale
Standard Deviation 4.98
|
9.697 score on a scale
Standard Deviation 5.67
|
SECONDARY outcome
Timeframe: through the completion of the study, on average 4 months.A comparison within change of sleep quality measured by the PROMIS Sleep inventory. The higher the total score, the more severe the symptom. Total scores less than 24 suggest no to slight sleep disturbance, 24-28 suggest mild disturbance, 29-38 moderate disturbance, and greater than 38 severe sleep disturbance. The score has a range of 0 to 40.
Outcome measures
| Measure |
iCanCope
n=40 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=42 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=40 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Sleep Functioning
|
22.4 score on a scale
Standard Deviation 6.4
|
22.2 score on a scale
Standard Deviation 7.3
|
21.4 score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: through the completion of the study, on average 4 months.the Short form survey 20- will measure quality of life across 8 subscales on respondent burden (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health). Scores were transformed linearly to 0-100 scales, with 0 and 100 assigned to the lowest and highest possible scores, where high value indicated better functioning.
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=34 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Short Form/Quality of Life
Intake (Baseline)
|
9.342 score on a scale
Standard Deviation 5.77
|
9.167 score on a scale
Standard Deviation 5.02
|
10.500 score on a scale
Standard Deviation 6.11
|
|
Short Form/Quality of Life
Discharge (an average of 2 weeks)
|
9.189 score on a scale
Standard Deviation 5.24
|
8.500 score on a scale
Standard Deviation 4.97
|
11.206 score on a scale
Standard Deviation 6.54
|
|
Short Form/Quality of Life
Follow-Up (on average 4 months)
|
8.737 score on a scale
Standard Deviation 4.84
|
9.556 score on a scale
Standard Deviation 6.39
|
11.588 score on a scale
Standard Deviation 6.37
|
SECONDARY outcome
Timeframe: through the completion of the study, on average 4 months.Chronic Pain Acceptance Questionnaire-Revised (CPAQ-Revised) 20-item scale designed to measure acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals will be measured across all groups. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). To score the CPAQ, add the items for Activity engagement and Pain willingness to obtain a score for each factor. To obtain the total score, add the scores for each factor together. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=34 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Chronic Pain Acceptance
Intake (Baseline)
|
65.517 score on a scale
Standard Deviation 12.64
|
71.968 score on a scale
Standard Deviation 11.26
|
70.148 score on a scale
Standard Deviation 13.01
|
|
Chronic Pain Acceptance
Discharge (an average of 2 weeks)
|
70.606 score on a scale
Standard Deviation 11.58
|
72.333 score on a scale
Standard Deviation 8.26
|
67.643 score on a scale
Standard Deviation 12.19
|
|
Chronic Pain Acceptance
Follow-Up (on average 4 months)
|
66.774 score on a scale
Standard Deviation 9.51
|
70.462 score on a scale
Standard Deviation 8.98
|
64.400 score on a scale
Standard Deviation 13.30
|
SECONDARY outcome
Timeframe: through the completion of the study, on average 4 months.Psychological Inflexibility in Pain Scale (PIPS) Avoidance subscale is a 10-item scale used to assess psychological inflexibility in people with chronic pain will be measured across all groups. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). The total score was calculated by summing the responses for each of the items. Higher scores indicate greater levels of psychological inflexibility. Total score range for the Avoidance subscale is 10-70. The PIPS outcome was originally registered as a single item.
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=34 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Psychological Inflexibility in Pain Scale: Avoidance
Intake (Baseline)
|
26.361 score on a scale
Standard Deviation 15.87
|
26.743 score on a scale
Standard Deviation 13.28
|
25.061 score on a scale
Standard Deviation 15.21
|
|
Psychological Inflexibility in Pain Scale: Avoidance
Discharge (an average of 2 weeks)
|
22.676 score on a scale
Standard Deviation 13.26
|
22.639 score on a scale
Standard Deviation 11.81
|
27.194 score on a scale
Standard Deviation 16.70
|
|
Psychological Inflexibility in Pain Scale: Avoidance
Follow-Up (on average 4 months)
|
22.750 score on a scale
Standard Deviation 13.56
|
22.735 score on a scale
Standard Deviation 13.13
|
27.290 score on a scale
Standard Deviation 14.58
|
SECONDARY outcome
Timeframe: through the completion of the study, on average 4 months.Psychological Inflexibility in Pain Scale (PIPS) Cognitive subscale is a 6-item scale used to assess psychological inflexibility in people with chronic pain will be measured across all groups. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). The total score was calculated by summing the responses for each of the items. Higher scores indicate greater levels of psychological inflexibility. Total score range for Cognitive subscale is 6-42. The PIPS outcome was originally registered as a single item.
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=34 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Psychological Inflexibility in Pain Scale: Cognitive
Intake (Baseline)
|
23.000 score on a scale
Standard Deviation 6.75
|
25.000 score on a scale
Standard Deviation 6.38
|
24.324 score on a scale
Standard Deviation 7.48
|
|
Psychological Inflexibility in Pain Scale: Cognitive
Discharge (an average of 2 weeks)
|
21.833 score on a scale
Standard Deviation 5.53
|
22.528 score on a scale
Standard Deviation 6.58
|
23.844 score on a scale
Standard Deviation 6.58
|
|
Psychological Inflexibility in Pain Scale: Cognitive
Follow-Up (on average 4 months)
|
20.108 score on a scale
Standard Deviation 6.72
|
21.800 score on a scale
Standard Deviation 7.02
|
22.938 score on a scale
Standard Deviation 7.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through the completion of the study, on average 4 months.Do individuals with NF-1 utilize the MBAA more readily because they are on the mobile application, via Five Facet Mindfulness Questionnaire. 39-item self-completed questionnaire measuring the five facets of mindfulness: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgmental (8 items), and Non-reactive (7 items). Total score ranges from 8 to 40. Higher scores indicating greater mindfulness.
Outcome measures
| Measure |
iCanCope
n=38 Participants
In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.
iCanCope: The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
|
iCanCop+Contingency Management
n=36 Participants
In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
iCanCope+Contingency Management: In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
|
Control Group
n=34 Participants
The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.
|
|---|---|---|---|
|
Mindfulness Based Alternative Approaches (MBAA)
|
27.5 score on a scale
Standard Deviation 3.9
|
28.2 score on a scale
Standard Deviation 2.4
|
28.9 score on a scale
Standard Deviation 2.5
|
Adverse Events
iCanCope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
iCanCop+Contingency Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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