Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis.

BACKGROUND: In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence. METHODS: iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11-20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months. RESULTS: Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25-100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC. CONCLUSIONS: The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.

Opportunities for cystic fibrosis care teams to support treatment adherence.

BACKGROUND: The purpose of this study was to identify the extent to which pediatric and adult cystic fibrosis (CF) care teams implement best practices in adherence assessment and counseling. METHODS: All US CF Foundation accredited programs were invited to participate in a web-based survey; 80% (92/115) of pediatric and 40% (38/95) of adult centers participated. Health care providers reported on current approaches and barriers to implementing adherence promotion practices. RESULTS: 64% discussed adherence at every clinic visit while only 8% used an objective assessment of adherence. Most centers reported frequent use of strategies to increase knowledge; behavioral and support strategies were used less regularly. Several barriers to adherence promotion were reported. CONCLUSIONS: Many opportunities exist for care teams to improve consistency in adherence practices and integrate a greater repertoire of effective counseling strategies into clinic visits. Adherence promotion practices should be considered for quality improvement (QI) projects.

User Preferences and Design Recommendations for an mHealth App to Promote Cystic Fibrosis Self-Management.

BACKGROUND: mHealth apps hold potential to provide automated, tailored support for treatment adherence among individuals with chronic medical conditions. Yet relatively little empirical research has guided app development and end users are infrequently involved in designing the app features or functions that would best suit their needs. Self-management apps may be particularly useful for people with chronic conditions like cystic fibrosis (CF) that have complex, demanding regimens. OBJECTIVE: The aim of this mixed-methods study was to involve individuals with CF in guiding the development of engaging, effective, user-friendly adherence promotion apps that meet their preferences and self-management needs. METHODS: Adults with CF (n=16, aged 21-48 years, 50% male) provided quantitative data via a secure Web survey and qualitative data via semi-structured telephone interviews regarding previous experiences using apps in general and for health, and preferred and unwanted features of potential future apps to support CF self-management. RESULTS: Participants were smartphone users who reported sending or receiving text messages (93%, 14/15) or emails (80%, 12/15) on their smartphone or device every day, and 87% (13/15) said it would be somewhat or very hard to give up their smartphone. Approximately one-half (53%, 8/15) reported having health apps, all diet/weight-related, yet many reported that existing nutrition apps were not well-suited for CF management. Participants wanted apps to support CF self-management with characteristics such as having multiple rather than single functions (eg, simple alarms), being specific to CF, and minimizing user burden. Common themes for desired CF app features were having information at one's fingertips, automation of disease management activities such as pharmacy refills, integration with smartphones' technological capabilities, enhancing communication with health care team, and facilitating socialization within the CF community. Opinions were mixed regarding gamification and earning rewards or prizes. Participants emphasized the need for customization options to meet individual preferences and disease management goals. CONCLUSIONS: Unique capabilities of emerging smartphone technologies (eg, social networking integration, movement and location detection, integrated sensors, or electronic monitors) make many of these requests possible. Involving end users in all stages of mHealth app development and collaborating with technology experts and the health care system may result in apps that maintain engagement, improve integration and automation, and ultimately impact self-management and health outcomes.

High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial.

BACKGROUND: High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD). METHODS: Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second. RESULTS: Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes. CONCLUSIONS: HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00181285.