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| Name | Class |
|---|---|
| Wellth Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (Group A) | No Intervention | Standard of care is dictated by the HME normal practices for new CPAP patients. | |
| Wellth App (Group B) | Experimental | Intervention is use of the Wellth app during the initial compliance period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellth app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean PAP Usage at 90 Days | Average nightly CPAP use for the 90 day time frame. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| % 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. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gina Merchant, PhD | ResMed | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Data | San Diego | California | 92123 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (Group A) | Standard of care procedures for new CPAP patients were followed. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The Baseline Analysis Population is comprised of participants that completed the first questionnaire. Missing data has been excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (Group A) | Standard of care procedures for new CPAP patients were followed. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Missing data was not included in this analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean PAP Usage at 90 Days | Average nightly CPAP use for the 90 day time frame. | All enrolled participants are included. | Posted | Mean | Standard Deviation | hours | 90 days |
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Adverse Event data was collected over 90 days for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Control group Standard of care procedures for new CPAP patients were followed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Team | ResMed | 800-424-0737 | clinicaltrials@resmed.com.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2019 | Apr 2, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2019 | Apr 2, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Randomization will consist of an allocation ratio of 2:1 (control:treatment).
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| 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. |
| 90 days |
| 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. | 90 days |
| Participant returned device |
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| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Perceived Disease Severity | These scores will be used as moderators of the intervention's effectiveness. The unit for this outcome is units on a scale, from 1 to 7. A higher score would mean increased agreeance with higher perceived disease severity. | Mean | Standard Deviation | units on a scale |
|
| Claustrophobia | These scores will be used as moderators of the intervention's effectiveness. The unit for this outcome is units on a scale between 1 and 5. A higher score would indicate more anxiety with claustrophobic situations. | Mean | Standard Deviation | units on a scale |
|
| Coping Skills | These scores will be used as moderators of the intervention's effectiveness. The unit for this outcome is points. Score ranges from 1 to 5. A higher score will have more of an influence on the relationship between the primary outcome (mean PAP usage) and the intervention. | Mean | Standard Deviation | units on a scale |
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| Health Literacy | These scores will be used as moderators of the intervention's effectiveness. The unit for this outcome is units on a scale, ranging from 1 to 5. A lower score would mean increased health literacy. | Mean | Standard Deviation | units on a scale |
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| 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. | Posted | Count of Participants | Participants | 90 days |
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|
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| 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. | Patient reported outcomes data. If participant did not answer both questionnaires, their data is missing from this analysis. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
|
|
|
| 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. | Patient reported outcomes data. Only participants that completed both questionnaires are reported here. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
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| 0 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | Group B | Wellth app 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Black or African American |
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| Hispanic or Latino |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| More than One |
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