A Mobile App Providing Individually-Tailored Psychoeducation about Sleep for Older Adults with Chronic Health Conditions and Low Health Literacy

Objective This paper reports the effect of a mobile app that provides tailored information about sleep to individuals aged 40 and older who have chronic health conditions and low health literacy. Methods The sleep module was a part of a multitopic app focused on chronic disease self-management. Participants were randomly assigned to receive sleep psychoeducation at reading levels equivalent to 3rd, 6th or 8th grade. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI), which was completed at baseline, after the intervention, and again three months later. Outcomes were assessed using repeated measures mixed effects models. Results Most participants were Black, Indigenous, or Other Persons of Color (BIPOC; 87%); they had average reading level at the 7th grade. Health literacy, socioeconomic status, number of health conditions, and the intervention’s effect were related to the PSQI. The PSQI score significantly decreased over the course of the three study visits for all groups, consistent with a small to medium effect size ( d = 0.40). No effect of treatment group was observed. Conclusion Results suggest that a brief tailored information intervention may be beneficial for individuals aged 40 and older who have low health literacy and chronic health conditions. Further development of the intervention may enhance its clinical effectiveness. Registered at [clinicaltrials.gov][1] [NCT02922439][2]. ### Competing Interest Statement Dr. Ownby is an applicant on a US patent application (US 2021/0065908) focused on automated assessment of patient understanding of health information. Dr. Ownby is a stockholder in Enalan Communications, Inc., a company that develops digital therapeutics. ### Clinical Trial NCT02922439 ### Clinical Protocols ### Funding Statement This study was funded by grants from the US National Heart, Lung, and Blood Institute (R56HL096578) and the US National Institute on Minority Health and Health Disparities (R01 MD010368) to Dr. Ownby. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: All procedures were approved by the Institutional Review Boards of Nova Southeastern University (2018-685-NSU) and of Emory University (MODCR001-IRB00087112). Participants provided verbal consent for initial screening procedures and written informed consent for all other aspects of their participation. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes [1]: http://clinicaltrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02922439&atom=%2Fmedrxiv%2Fearly%2F2024%2F01%2F03%2F2024.01.02.24300726.atom