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Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial.

ABSTRACT: Motivational enhancement (ME) shows promise as a means of increasing adherence to CPAP for OSA.We performed an open-label, parallel-arm, randomized controlled trial of CPAP only or CPAP + ME, recruiting individuals 45 to 75 years with moderate or severe OSA without marked sleepiness and with either established cardiovascular disease (CVD) or at risk for CVD. All participants received standardized CPAP support from a sleep technologist; those randomly assigned to CPAP + ME also received standardized ME delivered by a psychologist during two appointments and six phone calls over 32 weeks. Mixed-effect models with subject-specific intercepts and slopes were fitted to compare objective CPAP adherence between arms, adjusting for follow-up duration, randomization factors, and device manufacturer. All analyses were intention-to-treat.Overall, 83 participants (n = 42 CPAP only; n = 41 CPAP + ME) contributed 14,273 nights of data for 6 months. Participants were predominantly male (67%) and had a mean ± SD age of 63.9 ± 7.4 years, a BMI of 31.1 ± 5.2 kg/m(2), and an apnea-hypopnea index of 26.2 ± 12.9 events/h. In our fully adjusted model, average nightly adherence for 6 months was 99.0 min/night higher with CPAP + ME compared with CPAP only (P = .003; primary analysis). A subset of 52 participants remained in the study for 12 months; modeling these data yielded a consistent difference in adherence between arms of 97 min/night (P = .006) favoring CPAP + ME.ME delivered during brief appointments and phone calls resulted in a clinically significant increase in CPAP adherence. This strategy may represent a feasible approach for optimizing management of OSA.ClinicalTrials.gov; No.: NCT01261390; URL: www.clinicaltrials.gov.

SUBMITTER: Bakker JP

PROVIDER: S-EPMC4980541 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial.

Bakker Jessie P JP Wang Rui R Weng Jia J Aloia Mark S MS Toth Claudia C Morrical Michael G MG Gleason Kevin J KJ Rueschman Michael M Dorsey Cynthia C Patel Sanjay R SR Ware James H JH Mittleman Murray A MA Redline Susan S

Chest 20160324 2

<h4>Background</h4>Motivational enhancement (ME) shows promise as a means of increasing adherence to CPAP for OSA.<h4>Methods</h4>We performed an open-label, parallel-arm, randomized controlled trial of CPAP only or CPAP + ME, recruiting individuals 45 to 75 years with moderate or severe OSA without marked sleepiness and with either established cardiovascular disease (CVD) or at risk for CVD. All participants received standardized CPAP support from a sleep technologist; those randomly assigned t ...[more]

PMID: 27018174

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Project description:UnlabelledWe have designed an innovative randomized controlled trial for improving adherence with osteoporosis medications. Recruitment and randomization have been successful. Also, the counseling intervention has been well accepted by subjects randomized to this treatment arm.IntroductionWhile many effective treatments exist for osteoporosis, most people do not adhere to such treatments long term. No proven interventions exist to improve osteoporosis medication adherence. We report here on the design and initial enrollment in an innovative randomized controlled trial aimed at improving adherence to osteoporosis treatments.MethodsThe trial represents a collaboration between academic researchers and a state-run pharmacy benefits program for low-income older adults. Beneficiaries beginning treatment with a medication for osteoporosis are targeted for recruitment. We randomize consenting individuals to receive 12 months of mailed education (control arm) or an intervention consisting of one-on-one telephone-based counseling and the mailed education. Motivational interviewing forms the basis for the counseling program which is delivered by seven trained and supervised health counselors over ten telephone calls. The counseling sessions include scripted dialog and open-ended questions about medication adherence and its barriers, as well as structured questions. The primary end point of the trial is medication adherence measured over the 12-month intervention period. Secondary end points include fractures, nursing home admissions, health care resource utilization, and mortality.ResultsDuring the first 7 months of recruitment, we have screened 3,638 potentially eligible subjects. After an initial mailing, 1,115 (30.6%) opted out of telephone recruitment and 1,019 (28.0%) could not be successfully contacted. Of the remaining, 879 (24.2%) consented to participate and were randomized. Women comprise over 90% of all groups; mean ages range from 77 to 80 years old, and the majority in all groups was white. The distribution of osteoporosis medications was comparable across groups and the median number of different prescription drugs used in the prior year was eight to ten.ConclusionsWe have developed a novel intervention for improving osteoporosis medication adherence. The intervention is currently being tested in a large-scale randomized controlled trial. If successful, the intervention may represent a useful model for improving adherence to other chronic treatments.

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Dataset Information

Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial.

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Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial.

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