Obstructive Sleep Apnea
Conditions
Brief summary
This is a prospective, randomized, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to PAP therapy.
Detailed description
This is a prospective, randomized, two-arm, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to therapy. Randomization will include an allocation ratio of 2:1 (control:treatment). Participants will be recruited based on evidence that they are struggling to achieve adherence to therapy after the first 3 nights of usage. Two 'site to participant' contacts are required during this study. These contacts can either occur at the clinical site or remotely (e.g., by telephone). During the initial contact, their interest in the study and eligibility will be confirmed, then they will be consented, asked to complete the Baseline Questionnaire, and their demographic information will be collected on case report forms (CRFs). Participants randomized to the intervention (Group B) will be provided with information and assistance in downloading Restful to their smartphone and registering with Wellth. At the final contact (90 days), the participant will be asked to complete an End of Study Questionnaire and the investigative staff will collect PAP therapy data for the trial period and record it on CRFs. Participants in Group B will have access to the Restful app discontinued. This completes the participant's active participation in the study.
Interventions
BEHAVIORALWellth 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.
Sponsors
Wellth Inc.
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization will consist of an allocation ratio of 2:1 (control:treatment).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants (≥ 18 years of age) * New diagnosis of OSA * Prescribed CPAP or APAP for treatment of OSA * Prescribed a ResMed flow generator compatible with AirView * Owns a smart phone and is willing to download an app on their phone * Willing and able to give informed consent * Can read and comprehend written and spoken English
Exclusion criteria
* Have used PAP therapy in the past * Have been prescribed bi-level or adaptive servo-ventilation therapy * Are participating in another app-based research study * Cannot participate for the full duration of the study (at least 90 days) * Participants who have a medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this study, or constitutes an unacceptable risk to the participant for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean PAP Usage at 90 Days | 90 days | Average nightly CPAP use for the 90 day time frame. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % of Participants That Meet Medicare Compliance Standard | 90 days | Medicare 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. |
| Change in ESS Questionnaire Scores | 90 days | 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. |
| Change in FOSQ-10 Questionnaire Scores | 90 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (Group A) Standard of care procedures for new CPAP patients were followed. | 103 |
| 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. | 50 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant lost device | 0 | 1 |
| Overall Study | Participant returned device | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care (Group A) | Wellth App (Group B) | Total |
|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 12.2 | 48.6 years STANDARD_DEVIATION 11.1 | 48.9 years STANDARD_DEVIATION 11.8 |
| Claustrophobia Bad cold, difficult to breathe through nose | 2.3 units on a scale STANDARD_DEVIATION 1.1 | 2.2 units on a scale STANDARD_DEVIATION 1.1 | 2.3 units on a scale STANDARD_DEVIATION 1.1 |
| Claustrophobia Catch breath during vigorous exercise | 2.1 units on a scale STANDARD_DEVIATION 1 | 2.1 units on a scale STANDARD_DEVIATION 1.1 | 2.1 units on a scale STANDARD_DEVIATION 1 |
| Claustrophobia Snorkeling | 2.0 units on a scale STANDARD_DEVIATION 1.2 | 2.0 units on a scale STANDARD_DEVIATION 1.3 | 2.0 units on a scale STANDARD_DEVIATION 1.2 |
| Claustrophobia Swimming, wearing a nose plug | 2.1 units on a scale STANDARD_DEVIATION 1.3 | 2.0 units on a scale STANDARD_DEVIATION 1.2 | 2.1 units on a scale STANDARD_DEVIATION 1.2 |
| Claustrophobia Wearing a mask | 2.4 units on a scale STANDARD_DEVIATION 1.2 | 2.1 units on a scale STANDARD_DEVIATION 1.2 | 2.3 units on a scale STANDARD_DEVIATION 1.2 |
| Claustrophobia Wearing CPAP mask/being on therapy | 2.3 units on a scale STANDARD_DEVIATION 0.9 | 2.1 units on a scale STANDARD_DEVIATION 1.1 | 2.2 units on a scale STANDARD_DEVIATION 1 |
| Claustrophobia Working under car or sink | 1.8 units on a scale STANDARD_DEVIATION 0.9 | 1.9 units on a scale STANDARD_DEVIATION 1.1 | 1.8 units on a scale STANDARD_DEVIATION 1 |
| Coping Skills | 3.53 units on a scale STANDARD_DEVIATION 0.46 | 3.29 units on a scale STANDARD_DEVIATION 0.51 | 3.45 units on a scale STANDARD_DEVIATION 0.49 |
| Health Literacy | 1.3 units on a scale STANDARD_DEVIATION 0.6 | 1.4 units on a scale STANDARD_DEVIATION 0.6 | 1.4 units on a scale STANDARD_DEVIATION 0.6 |
| Perceived Disease Severity | 5.48 units on a scale STANDARD_DEVIATION 0.99 | 5.33 units on a scale STANDARD_DEVIATION 1.31 | 5.43 units on a scale STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 13 Participants | 4 Participants | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 14 Participants | 6 Participants | 20 Participants |
| Race/Ethnicity, Customized Race/Ethnicity More than One | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 63 Participants | 30 Participants | 93 Participants |
| Sex: Female, Male Female | 48 Participants | 17 Participants | 65 Participants |
| Sex: Female, Male Male | 55 Participants | 33 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 51 |
| other Total, other adverse events | 0 / 111 | 0 / 51 |
| serious Total, serious adverse events | 0 / 111 | 0 / 51 |
Outcome results
Primary
Mean PAP Usage at 90 Days
Average nightly CPAP use for the 90 day time frame.
Time frame: 90 days
Population: All enrolled participants are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Group A) | Mean PAP Usage at 90 Days | 4.67 hours | Standard Deviation 2.2 |
| Wellth App (Group B) | Mean PAP Usage at 90 Days | 4.59 hours | Standard Deviation 2.36 |
Secondary
Change in ESS Questionnaire Scores
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.
Time frame: 90 days
Population: Patient reported outcomes data. If participant did not answer both questionnaires, their data is missing from this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Group A) | Change in ESS Questionnaire Scores | -1.99 score on a scale | Standard Deviation 3.75 |
| Wellth App (Group B) | Change in ESS Questionnaire Scores | -2.63 score on a scale | Standard Deviation 3.49 |
Secondary
Change in FOSQ-10 Questionnaire Scores
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.
Time frame: 90 days
Population: Patient reported outcomes data. Only participants that completed both questionnaires are reported here.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Group A) | Change in FOSQ-10 Questionnaire Scores | 0.96 score on a scale | Standard Deviation 2.55 |
| Wellth App (Group B) | Change in FOSQ-10 Questionnaire Scores | 1.74 score on a scale | Standard Deviation 2.5 |
Secondary
% of Participants That Meet Medicare Compliance Standard
Medicare 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.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (Group A) | % of Participants That Meet Medicare Compliance Standard | 88 Participants |
| Wellth App (Group B) | % of Participants That Meet Medicare Compliance Standard | 46 Participants |