Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research is clear that adherence patterns are established early in treatment, we evaluated an mHealth intervention to facilitate early, productive interactions between patient and provider that improve the quality of care and ultimately improve adherence with therapy and outcomes. The mHealth intervention can allow for improved, more timely delivery of our Sleep Apena Self-Management Program.
The objective of this proposal is to evaluate a mHealth system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient-centered, collaborative management for patients who are prescribed the gold-standard treatment, continuous positive airway pressure (CPAP).
The evaluative aspect of this proposal is designed as a pilot randomized, controlled clinical trial-- Usual Care (Usual Care (control; UC); Self-Management Care (intervention 1; SM); and Self-Management via mHealth (intervention 2; SM-Mobile). The key feature of the SM-Mobile intervention is the use of a system that that allows for receiving the SM protocol via website at their convenience. The provider is able provide more directed feedback to the patient based on the telemedicine interaction, and the patient benefits from increased contact with the provider. Specific inclusion and exclusion criteria will be used, including, age > 18 years; confirmed diagnosis of moderate-severe OSA; being newly prescribed CPAP therapy; having chronic symptoms as noted on screening symptom checklist; and fluency in English. Patients will be recruited from local Sleep Clinics. Participants will be enrolled for a 4-month time period. Groups will be compared on quantitative and qualitative measures.
Overall Sample: The overall sample was aged 53.1±13.6, had a body mass index (BMI) of 32.6±5.7, apnea-hypopnea index (AHI) of 30.3±18.9, and a baseline Epworth Sleepiness Score (ESS) of 11.8±5.3. 90% of the sample were men. There were no significant differences between the groups on BMI, AHI, ESS, sleep apnea symptoms, insomnia symptoms or depressive symptoms.
Aim 1: To examine the effect of the Self-Management Care delivered by mHealth (SM-Mobile) intervention compared to Usual Care (UC) and Self-Management Care (SM) on level of CPAP adherence relative to Usual Care. The three groups were compared to see if there were differences on adherence. No statistically significant differences were found between UC, SM and SM-Mobile groups at the 2-month timepoint (4.0±2.2, 3.9±2.4, and 3.8±2.4 hours per night, respectively; F=.113; p=.893). or the 4-month timepoint (3.6±2.2, 3.6±2.5, and 3.6±2.5 hours per night, respectively; F=.041; p=.959).
In addition, we had CPAP efficacy metrics, including the residual Apnea-Hypopnea Index (AHI) and mask leak. At the 4-month time point, CPAP resulted in very good control of sleep apnea as evidenced by the mean AHI of 3.3 across the entire group. There were no group differences on residual AHI (UC, SM, and SM-Mobile of 3.0, 3.6 and 3.3, respectively). The same was true at the 2-month timepoint (mean residual AHI = 3.4; 3.2, 3.7 and 3.5, respectively). Mask leak was also well within normal limits at both the 2-month (mean = .14; .11, .15, and .16 lps) and 4-month timepoints (mean = 12; .12, .12, and .13 lps).
Aim 2: To examine the effect of the SM-Mobile intervention, compared to Usual Care and Self-Management Care, on the patient's experience of the quality of patient-centered, collaborative care (as measured by the Patient Assessment of Chronic Illness Care [PACIC]). The PACIC results in a total score and five subscale scores (Patient Activation, Delivery/support, Goal, Problem-solving, and Follow-up). The three intervention groups did not differ statistically (UC, SM, SM-Mobile) (3.3±1.1; 3.4±1.1; 3.4±1.1, respectively) on the PACIC Total Score. Higher scores indicated higher ratings of chronic illness care. The range of scores for the subscales was 2.6 to 3.7, with the higher overall scores on the Delivery/support subscale and the lowest on the Follow-up subscale. Overall, the scores were as high or higher than those reported in the literature for patients with similar chronic medical conditions, such as diabetes, asthma, depression and arthritis, indicating that the interventions studied in this project resulted in higher than average chronic illness care, as rated by patients.
Aim 3: To examine the effect of SM-Mobile, compared to UC and SM, on OSA apnea outcomes (e.g., OSA symptoms and OSA-specific health-related quality of life [HRQOL]). The Epworth Sleepiness Scale scores dropped from baseline to 2-months by 3.4 points and to 4-months by 4.0 points. Given that the cut-off for the ESS is 10 points (above which is considered sleepy; below which is considered within normal limits), all three interventions combined to reduce the sleepiness level of the sample from the sleepy range to the normal limits range (i.e., from mean ESS score of 11.8 to mean ESS score of 8.4 and 7.8 for 2-months and 4-months respectively). The mean ESS scores did not differ significantly between the groups at either the 2-month timepoint (8.3, 8.5, and 8.5 for the 3 groups respectively, UC, SM and SM-Mobile) or the 4-month timepoint (7.9, 7.4, and 8.2 for the 3 groups respectively, UC, SM and SM-Mobile). Sleep quality as measured by the Pittsburgh Sleep Quality Index was also significantly improved across all 3 groups from baseline (mean 11.9) to 2-months (2.8 points, mean 9.1) and to 4-months (2.9 points, mean 9.0). The mean PSQI scores did not differ significantly between the groups at either the 2-month timepoint (8.7, 9.4, and 9.5 for the 3 groups respectively, UC, SM and SM-Mobile) or the 4-month timepoint (8.5, 9.0, and 9.7 for the 3 groups respectively, UC, SM and SM-Mobile).
Delivering sleep apnea support via the Sleep Apnea Self-Management Program via two different formats was equivalent to the Usual Care provided at the VA San Diego Healthcare System. Patients in all three interventions had adequate levels of CPAP use, improved their sleep quality, reduced their daytime sleepiness, and had better daytime outcomes. The findings of this study have the potential to improve the quality of clinical care provided to Veteran patients with obstructive sleep apnea who are prescribed CPAP therapy.
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Grant Number: I01HX000942-01A2
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