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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00NR011173 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| ANF | UNKNOWN |
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The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.
Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes. Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly. The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored | Experimental | Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions |
|
| Usual care | Active Comparator | The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored | Behavioral | Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Nightly CPAP Use | Mean CPAP use, hrs/night | 1 week |
| Nightly CPAP Use | Mean CPAP use, hrs/night | 1 month |
| Nightly CPAP Use | Mean CPAP use, hrs/night | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Sleep Time on CPAP | % of Total Sleep Time (TST) using CPAP | 1 week |
| Proportion of Participants Who Complete Protocol After Allocation | Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy M Sawyer, PhD | The Pennsylvania State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20354236 | Background | Sawyer AM, Deatrick JA, Kuna ST, Weaver TE. Differences in perceptions of the diagnosis and treatment of obstructive sleep apnea and continuous positive airway pressure therapy among adherers and nonadherers. Qual Health Res. 2010 Jul;20(7):873-92. doi: 10.1177/1049732310365502. Epub 2010 Mar 30. | |
| 21071166 | Background | Sawyer AM, Canamucio A, Moriarty H, Weaver TE, Richards KC, Kuna ST. Do cognitive perceptions influence CPAP use? Patient Educ Couns. 2011 Oct;85(1):85-91. doi: 10.1016/j.pec.2010.10.014. Epub 2010 Nov 10. |
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Recruitment period 12/2011 through 1/2014 Location type: clinical sleep center
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored | Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy |
| FG001 | Usual Care | The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored | Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Nightly CPAP Use | Mean CPAP use, hrs/night | Posted | Mean | Standard Deviation | hours/night | 1 week |
|
3 months
Electronic medical record review at research visit to identify serious adverse events (e.g., hospitalization, emergency department visit) Checklist adverse events at research visit to identify adverse event occurrence since last research visit
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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 | Tailored | Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy |
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Sampling bias with convenience sampling leading to relatively few PAP users meeting definition of non-adherence (threshold definition \
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy M. Sawyer, PhD | The Pennsylvania State University | 814-863-1020 | ams24@psu.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D010349 | Patient Compliance |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D057285 | Precision Medicine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Usual care | Other | Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care |
|
|
| Duration of protocol period |
| Proportion of Participants Who Withdrawal | Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT | Duration of protocol period |
| Acceptability of Study Intervention and Comparative Group | Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to "interview" at study termination and debriefing (3 months) | 3 months |
| 21652236 | Background | Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011 Dec;15(6):343-56. doi: 10.1016/j.smrv.2011.01.003. Epub 2011 Jun 8. |
| 14572127 | Background | Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, Pack AI. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep. 2003 Sep;26(6):727-32. doi: 10.1093/sleep/26.6.727. |
| 29246264 | Derived | Yang H, Watach A, Varrasse M, King TS, Sawyer AM. Clinical Trial Enrollment Enrichment in Resource-Constrained Research Environments: Multivariable Apnea Prediction (MAP) Index in SCIP-PA Trial. J Clin Sleep Med. 2018 Feb 15;14(2):173-181. doi: 10.5664/jcsm.6926. |
| Post-allocation Exclude-refused PAP |
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| Post-allocation Exclude-other treatment |
|
| Withdrawal - no polysomnography |
|
| BG001 | Usual Care | The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Body Mass Index, Continuous | Mean | Standard Deviation | kg/m2 |
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| Marital Status, Categorical | Number | participants |
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| Daytime Sleepiness by Epworth Sleepiness Scale, Continuous | Total score (sum) range is 0-24; higher scores indicate worse daytime subjective sleepiness | Mean | Standard Deviation | units on a scale |
|
| Apnea-hypopnea Index (AHI), events/hr, Continuous | Mean | Standard Deviation | events/hour |
|
| Apnea-hypopnea Index (AHI), Categorical | Number | participants |
|
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
|
|
|
| Primary | Nightly CPAP Use | Mean CPAP use, hrs/night | Posted | Mean | Standard Deviation | hours/night | 1 month |
|
|
|
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| Primary | Nightly CPAP Use | Mean CPAP use, hrs/night | Posted | Mean | Standard Deviation | hours/night | 3 months |
|
|
|
|
| Secondary | Proportion of Sleep Time on CPAP | % of Total Sleep Time (TST) using CPAP | Randomized participants with complete primary outcome data and secondary outcome data (total sleep time) measured by concurrent wrist actigraphy during first week of PAP treatment | Posted | Mean | Standard Deviation | percentage of TST on PAP | 1 week |
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|
|
|
| Secondary | Proportion of Participants Who Complete Protocol After Allocation | Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT | Considers only participant withdrawals, administrative withdrawals for incomplete protocol procedures due to attrition; does NOT include excluded by a priori determined exclusion criteria for protocol | Posted | Number | percentage of participants | Duration of protocol period |
|
|
|
| Secondary | Proportion of Participants Who Withdrawal | Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT | Considers only participant withdrawals requested from study | Posted | Number | percentage of participants | Duration of protocol period |
|
|
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| Secondary | Acceptability of Study Intervention and Comparative Group | Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to "interview" at study termination and debriefing (3 months) | Acceptability rating by participants allocated to "interview" at study termination and debriefing; self-reported rating for binary response to satisfaction with study experience (yes/no); reported as percentage responding "yes"; no data available for participants who withdrew or were excluded prior to 3-month visit. | Posted | Number | percentage of allocated responding "yes" | 3 months |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Usual Care | The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care | 0 | 57 | 0 | 57 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D001519 | Behavior |
| D017530 | Health Care Quality, Access, and Evaluation |