Patient Compliance, Sleep Apnea, Obstructive
Conditions
Keywords
Social support, Cognition, Adaptation, psychological, Health behavior, Patient education
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTailored
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
OTHERUsual 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
Sponsors
National Institute of Nursing Research (NINR)
ANF
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* males and females \>/= 18 years of age * newly diagnosed with apnea/hypopnea index \>/= 10 events/hr * CPAP naive * able to read and speak English
Exclusion criteria
* previous diagnosis and/or treatment of OSA * major new psychiatric diagnosis within 6 months of study enrollment * require supplemental oxygen or bilevel positive airway pressure on CPAP titration polysomnogram * diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb movements \>/= 10 events/hr with arousal, central sleep apnea with \>/= 5 central events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nightly CPAP Use | 1 week | Mean CPAP use, hrs/night |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Sleep Time on CPAP | 1 week | % of Total Sleep Time (TST) using CPAP |
| Proportion of Participants Who Complete Protocol After Allocation | Duration of protocol period | Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT |
| Proportion of Participants Who Withdrawal | Duration of protocol period | Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT |
| Acceptability of Study Intervention and Comparative Group | 3 months | 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) |
Countries
United States
Participant flow
Recruitment details
Recruitment period 12/2011 through 1/2014 Location type: clinical sleep center
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Post-allocation Exclude- AHI<10 | 18 | 12 |
| Overall Study | Post-allocation Exclude-other treatment | 6 | 7 |
| Overall Study | Post-allocation Exclude-refused PAP | 0 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
| Overall Study | Withdrawal - no polysomnography | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Tailored | Usual Care |
|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 11.1 | 52.5 years STANDARD_DEVIATION 11.7 | 50.1 years STANDARD_DEVIATION 10.5 |
| Apnea-hypopnea Index (AHI), Categorical Mild: 5-15 events/hr | 11 participants | 3 participants | 8 participants |
| Apnea-hypopnea Index (AHI), Categorical Moderate: >15-30 events/hr | 20 participants | 13 participants | 7 participants |
| Apnea-hypopnea Index (AHI), Categorical Severe: >30 events/hr | 29 participants | 14 participants | 15 participants |
| Apnea-hypopnea Index (AHI), events/hr, Continuous | 35.9 events/hour STANDARD_DEVIATION 25.2 | 33.9 events/hour STANDARD_DEVIATION 21.3 | 38.0 events/hour STANDARD_DEVIATION 28.8 |
| Body Mass Index, Continuous | 38.0 kg/m2 STANDARD_DEVIATION 9.2 | 37.0 kg/m2 STANDARD_DEVIATION 8.1 | 39.0 kg/m2 STANDARD_DEVIATION 10.3 |
| Daytime Sleepiness by Epworth Sleepiness Scale, Continuous | 19.6 units on a scale STANDARD_DEVIATION 5.2 | 18.7 units on a scale STANDARD_DEVIATION 5.1 | 20.4 units on a scale STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 28 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status, Categorical Married | 45 participants | 20 participants | 25 participants |
| Marital Status, Categorical Separated or Divorced | 9 participants | 6 participants | 3 participants |
| Marital Status, Categorical Single | 4 participants | 2 participants | 2 participants |
| Marital Status, Categorical Widow(er) | 2 participants | 2 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 24 Participants | 27 Participants |
| Region of Enrollment United States | 60 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 18 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 42 Participants | 19 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 57 |
| serious Total, serious adverse events | 0 / 61 | 0 / 57 |
Outcome results
Primary
Nightly CPAP Use
Mean CPAP use, hrs/night
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored | Nightly CPAP Use | 5.1 hours/night | Standard Deviation 2.05 |
| Usual Care | Nightly CPAP Use | 5.1 hours/night | Standard Deviation 1.66 |
Comparison: Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trialp-value: 0.9t-test, 2 sided
Primary
Nightly CPAP Use
Mean CPAP use, hrs/night
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored | Nightly CPAP Use | 4.8 hours/night | Standard Deviation 2.27 |
| Usual Care | Nightly CPAP Use | 4.7 hours/night | Standard Deviation 1.85 |
Comparison: Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trialp-value: 0.89t-test, 2 sided
Primary
Nightly CPAP Use
Mean CPAP use, hrs/night
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored | Nightly CPAP Use | 6.4 hours/night | Standard Deviation 2.01 |
| Usual Care | Nightly CPAP Use | 5.8 hours/night | Standard Deviation 1.35 |
Comparison: Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trialp-value: 0.2t-test, 2 sided
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)
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored | Acceptability of Study Intervention and Comparative Group | 100 percentage of allocated responding yes |
| Usual Care | Acceptability of Study Intervention and Comparative Group | 100 percentage of allocated responding yes |
Secondary
Proportion of Participants Who Complete Protocol After Allocation
Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT
Time frame: Duration of protocol period
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored | Proportion of Participants Who Complete Protocol After Allocation | 88.5 percentage of participants |
| Usual Care | Proportion of Participants Who Complete Protocol After Allocation | 86 percentage of participants |
Secondary
Proportion of Participants Who Withdrawal
Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT
Time frame: Duration of protocol period
Population: Considers only participant withdrawals requested from study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored | Proportion of Participants Who Withdrawal | 6.56 percentage of participants |
| Usual Care | Proportion of Participants Who Withdrawal | 7.02 percentage of participants |
Secondary
Proportion of Sleep Time on CPAP
% of Total Sleep Time (TST) using CPAP
Time frame: 1 week
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored | Proportion of Sleep Time on CPAP | 64.58 percentage of TST on PAP | Standard Deviation 12.99 |
| Usual Care | Proportion of Sleep Time on CPAP | 65.73 percentage of TST on PAP | Standard Deviation 14.25 |
Comparison: Exploratory outcome of PAP use defined within the sleep period, TST (total sleep time).p-value: 0.78t-test, 2 sided