Trial Outcomes & Findings for Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients (NCT NCT03851094)
NCT ID: NCT03851094
Last Updated: 2021-06-15
Results Overview
Average nightly CPAP use for the 90 day time frame.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
166 participants
Primary outcome timeframe
90 days
Results posted on
2021-06-15
Participant Flow
Participant milestones
| Measure |
Standard of Care (Group A)
Standard of care procedures for new CPAP patients were followed.
|
Wellth App (Group B)
Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
55
|
|
Overall Study
COMPLETED
|
111
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Standard of Care (Group A)
Standard of care procedures for new CPAP patients were followed.
|
Wellth App (Group B)
Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Participant lost device
|
0
|
1
|
|
Overall Study
Participant returned device
|
0
|
2
|
Baseline Characteristics
Missing data was not included in this analysis.
Baseline characteristics by cohort
| Measure |
Standard of Care (Group A)
n=103 Participants
Standard of care procedures for new CPAP patients were followed.
|
Wellth App (Group B)
n=50 Participants
Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 12.2 • n=102 Participants • Missing data was not included in this analysis.
|
48.6 years
STANDARD_DEVIATION 11.1 • n=49 Participants • Missing data was not included in this analysis.
|
48.9 years
STANDARD_DEVIATION 11.8 • n=151 Participants • Missing data was not included in this analysis.
|
|
Sex: Female, Male
Female
|
48 Participants
n=103 Participants
|
17 Participants
n=50 Participants
|
65 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=103 Participants
|
33 Participants
n=50 Participants
|
88 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native
|
0 Participants
n=103 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
13 Participants
n=103 Participants
|
4 Participants
n=50 Participants
|
17 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
5 Participants
n=103 Participants
|
4 Participants
n=50 Participants
|
9 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
14 Participants
n=103 Participants
|
6 Participants
n=50 Participants
|
20 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian or Other Pacific Islander
|
3 Participants
n=103 Participants
|
2 Participants
n=50 Participants
|
5 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
63 Participants
n=103 Participants
|
30 Participants
n=50 Participants
|
93 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · More than One
|
5 Participants
n=103 Participants
|
4 Participants
n=50 Participants
|
9 Participants
n=153 Participants
|
|
Perceived Disease Severity
|
5.48 units on a scale
STANDARD_DEVIATION 0.99 • n=103 Participants
|
5.33 units on a scale
STANDARD_DEVIATION 1.31 • n=50 Participants
|
5.43 units on a scale
STANDARD_DEVIATION 1.10 • n=153 Participants
|
|
Claustrophobia
Swimming, wearing a nose plug
|
2.1 units on a scale
STANDARD_DEVIATION 1.3 • n=103 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.2 • n=50 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.2 • n=153 Participants
|
|
Claustrophobia
Catch breath during vigorous exercise
|
2.1 units on a scale
STANDARD_DEVIATION 1.0 • n=103 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.1 • n=50 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.0 • n=153 Participants
|
|
Claustrophobia
Bad cold, difficult to breathe through nose
|
2.3 units on a scale
STANDARD_DEVIATION 1.1 • n=103 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 1.1 • n=50 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 1.1 • n=153 Participants
|
|
Claustrophobia
Wearing a mask
|
2.4 units on a scale
STANDARD_DEVIATION 1.2 • n=103 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.2 • n=50 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 1.2 • n=153 Participants
|
|
Claustrophobia
Snorkeling
|
2.0 units on a scale
STANDARD_DEVIATION 1.2 • n=103 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.3 • n=50 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.2 • n=153 Participants
|
|
Claustrophobia
Working under car or sink
|
1.8 units on a scale
STANDARD_DEVIATION 0.9 • n=103 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 1.1 • n=50 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 1.0 • n=153 Participants
|
|
Claustrophobia
Wearing CPAP mask/being on therapy
|
2.3 units on a scale
STANDARD_DEVIATION 0.9 • n=103 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.1 • n=50 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 1.0 • n=153 Participants
|
|
Coping Skills
|
3.53 units on a scale
STANDARD_DEVIATION 0.46 • n=103 Participants
|
3.29 units on a scale
STANDARD_DEVIATION 0.51 • n=50 Participants
|
3.45 units on a scale
STANDARD_DEVIATION 0.49 • n=153 Participants
|
|
Health Literacy
|
1.3 units on a scale
STANDARD_DEVIATION 0.6 • n=103 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 0.6 • n=50 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 0.6 • n=153 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: All enrolled participants are included.
Average nightly CPAP use for the 90 day time frame.
Outcome measures
| Measure |
Standard of Care (Group A)
n=111 Participants
Standard of care procedures for a new CPAP patient were applied.
|
Wellth App (Group B)
n=55 Participants
Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
|
|---|---|---|
|
Mean PAP Usage at 90 Days
|
4.67 hours
Standard Deviation 2.20
|
4.59 hours
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: 90 daysMedicare compliance standard is using the PAP therapy for at least 4 hours per day on at least 70% of the days in a consecutive 30-day period any time in the first 90 days of therapy. Those that meet this standard are counted in the results below and divided by all patients.
Outcome measures
| Measure |
Standard of Care (Group A)
n=111 Participants
Standard of care procedures for a new CPAP patient were applied.
|
Wellth App (Group B)
n=55 Participants
Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
|
|---|---|---|
|
% of Participants That Meet Medicare Compliance Standard
|
88 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Patient reported outcomes data. If participant did not answer both questionnaires, their data is missing from this analysis.
Epworth Sleepiness Scale (ESS) will be administered at baseline and 90 days. The unit for this outcome is points. The total score can range from 0 to 24. A larger change or change that decreases from baseline will represent a better outcome. A smaller change or change that increases from baseline will represent a worse outcome. A higher score indicates worse symptoms.
Outcome measures
| Measure |
Standard of Care (Group A)
n=92 Participants
Standard of care procedures for a new CPAP patient were applied.
|
Wellth App (Group B)
n=40 Participants
Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
|
|---|---|---|
|
Change in ESS Questionnaire Scores
|
-1.99 score on a scale
Standard Deviation 3.75
|
-2.63 score on a scale
Standard Deviation 3.49
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Patient reported outcomes data. Only participants that completed both questionnaires are reported here.
Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be administered at baseline and 90 days. The unit for this outcome is points. The range of scores is 5 to 20. Higher scores indicate better functional status. A larger change or change that decreases from baseline will represent a better outcome. A smaller change or change that increases from baseline will represent a worse outcome.
Outcome measures
| Measure |
Standard of Care (Group A)
n=92 Participants
Standard of care procedures for a new CPAP patient were applied.
|
Wellth App (Group B)
n=40 Participants
Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
|
|---|---|---|
|
Change in FOSQ-10 Questionnaire Scores
|
0.96 score on a scale
Standard Deviation 2.55
|
1.74 score on a scale
Standard Deviation 2.50
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
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