Trial Outcomes & Findings for Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients (NCT NCT03962491)

NCT ID: NCT03962491

Last Updated: 2022-12-07

Results Overview

Number of days daily surveys completed

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

28-day daily survey period

Results posted on

2022-12-07

Participant Flow

Participant milestones

Participant milestones
Measure
Daily Self-Monitoring Surveys
Asked to complete daily self-monitoring surveys. Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
Daily Self-Monitoring Surveys + Contingency Management
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
Overall Study
STARTED
35
46
Overall Study
COMPLETED
31
41
Overall Study
NOT COMPLETED
4
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Daily Self-Monitoring Surveys
Asked to complete daily self-monitoring surveys. Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
Daily Self-Monitoring Surveys + Contingency Management
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
Overall Study
Lost to Follow-up
4
5

Baseline Characteristics

Mobile-Based Contingency Management to Promote Daily Self-monitoring in Primary Care Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Daily Self-Monitoring Surveys
n=35 Participants
Asked to complete daily self-monitoring surveys. Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
Daily Self-Monitoring Surveys + Contingency Management
n=46 Participants
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
Total
n=81 Participants
Total of all reporting groups
Age, Continuous
45.71 years
STANDARD_DEVIATION 12.39 • n=5 Participants
44.02 years
STANDARD_DEVIATION 16.12 • n=7 Participants
44.76 years
STANDARD_DEVIATION 14.55 • n=5 Participants
Sex/Gender, Customized
Female
28 Participants
n=5 Participants
33 Participants
n=7 Participants
61 Participants
n=5 Participants
Sex/Gender, Customized
Male
7 Participants
n=5 Participants
12 Participants
n=7 Participants
19 Participants
n=5 Participants
Sex/Gender, Customized
Other
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants
n=5 Participants
40 Participants
n=7 Participants
72 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
White
32 Participants
n=5 Participants
40 Participants
n=7 Participants
72 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United States
35 participants
n=5 Participants
46 participants
n=7 Participants
81 participants
n=5 Participants

PRIMARY outcome

Timeframe: 28-day daily survey period

Number of days daily surveys completed

Outcome measures

Outcome measures
Measure
Daily Self-Monitoring Surveys
n=35 Participants
Asked to complete daily self-monitoring surveys. Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
Daily Self-Monitoring Surveys + Contingency Management
n=46 Participants
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
Number of Daily Self-monitoring Surveys Completed
23.06 Surveys completed
Standard Deviation 6.97
26.09 Surveys completed
Standard Deviation 3.85

PRIMARY outcome

Timeframe: 28-day daily survey period

Largest number of consecutive days wherein daily surveys were completed

Outcome measures

Outcome measures
Measure
Daily Self-Monitoring Surveys
n=35 Participants
Asked to complete daily self-monitoring surveys. Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
Daily Self-Monitoring Surveys + Contingency Management
n=46 Participants
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
Longest Period of Sustained Adherence to Daily Survey Completion
17.11 number of days
Standard Deviation 9.36
22.07 number of days
Standard Deviation 7.76

SECONDARY outcome

Timeframe: 28-day daily survey period

Mean time to complete daily surveys

Outcome measures

Outcome measures
Measure
Daily Self-Monitoring Surveys
n=35 Participants
Asked to complete daily self-monitoring surveys. Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
Daily Self-Monitoring Surveys + Contingency Management
n=46 Participants
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
Daily Survey Completion Time
8.71 minutes
Standard Deviation 33.03
5.78 minutes
Standard Deviation 9.66

SECONDARY outcome

Timeframe: 28-day follow-up

CM App Acceptability was measured using a 8 item scale asking about experiences using the app. Each item was rated on a 0 - 10 Likert scale with higher scores indicating more positive responses. Scores for each item are reported separately.

Outcome measures

Outcome measures
Measure
Daily Self-Monitoring Surveys
n=35 Participants
Asked to complete daily self-monitoring surveys. Daily Self-Monitoring Surveys: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
Daily Self-Monitoring Surveys + Contingency Management
n=46 Participants
Asked to complete daily self-monitoring surveys, with opportunity for monetary rewards. Daily Self-Monitoring Surveys + Contingency Management: Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
CM App Acceptability
Easy to use
7.71 score on a scale
Standard Deviation 1.11
6.67 score on a scale
Standard Deviation 1.23
CM App Acceptability
Overall satisfaction
7.78 score on a scale
Standard Deviation 1.48
7.31 score on a scale
Standard Deviation 1.49
CM App Acceptability
Useful
6.58 score on a scale
Standard Deviation 2.17
6.82 score on a scale
Standard Deviation 2.30
CM App Acceptability
Appealing
7.13 score on a scale
Standard Deviation 2.03
7.50 score on a scale
Standard Deviation 1.69
CM App Acceptability
Bothersome
6.95 score on a scale
Standard Deviation 2.16
5.50 score on a scale
Standard Deviation 3.04
CM App Acceptability
Willing to use
7.09 score on a scale
Standard Deviation 2.43
8.11 score on a scale
Standard Deviation 1.05
CM App Acceptability
Help you cope with pain
4.25 score on a scale
Standard Deviation 2.15
4.87 score on a scale
Standard Deviation 2.45

OTHER_PRE_SPECIFIED outcome

Timeframe: 28-day daily survey period to 28-day follow-up

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28-day daily survey period to 28-day follow-up

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28-day daily survey period to 28-day follow-up

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28-day daily survey period to 28-day follow-up

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28-day daily survey period to 28-day follow-up

Outcome measures

Outcome data not reported

Adverse Events

Daily Self-Monitoring Surveys

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Daily Self-Monitoring Surveys + Contingency Management

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

Kathryn Polak, PhD

Virginia Commonwealth University

Phone: (804) 827-1184

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place