Complicaciones no pulmonares

The proposed study will be exempted from the U.S. Department of Health and Human Services (HHS) human subject regulations because I will conduct secondary analyses of existing datasets. Ethical approvals for all parent studies were obtained from the University of Pittsburgh Institutional Review Board prior to data collection.

Human Participants Involvement and Characteristics. I will include at least 130 individuals for the first manuscript, 60 individuals from the first dataset and at least 70 from the Result Study (R01 AG046906). All participants of the parent studies were persons with mild cognitive impairment and provided written informed consent before participating in the studies. The following criteria were used to determine subject eligibility for the parent studies.

1) current ADRC consensus diagnosis of MCI; 2) at least 50 years of age; 3) community-dwelling; and 4) have a family member or kin-like friend who also agreed to participate. Individuals were excluded if they have active, untreated primary psychiatric disorders (e.g., major depression, anxiety disorder based on screening with the HAM-D).

While the parent study of the second manuscript, the Habit Study (P01 NR010949), originally included 167 persons with type II diabetes mellitus aged 40 and older, I will include persons aged 50 or above to examine late-life chronic disorder. The following criteria were used to determine subject eligibility for the Habit Study. 1) at least 40 years of age; 2) take one or more medications prescribed by a physician; 3) must be self-managing their medications; and 4) English speaker and have access to a telephone. The last manuscript will combine two datasets, the Result Study and the Habit Study, the above inclusion and exclusion criteria will be applied.

Inclusion of persons with potentially impaired decisional capacity. For the parent studies involving persons with MCI, determinations of capacity to consent to the parent studies were based on a participant’s ability to express an understanding the study’s purpose, procedures, risks, and benefits during a one on one discussion with a member of the research team (investigator or trained project director).

Sources of Materials. The parent studies will provide all the data necessary for this proposed study. The sources of materials for the parent studies involving persons with MCI are retrieved from REDCap, a web-based system, which provides secure data entry with real-time validation. Permission to extract data from existing databases was obtained from participants during the informed consent process. The Habit Study baseline self-reported data were stored on the secure centralized server and only the PI and the project coordinator of the Habit Study have access to subject identities.

Potential Risks and Benefits of the Proposed Research. The date from the parent studies will remain de-identified for the proposed study so that this study has no direct risks to the participants. However, the findings from this study may suggest a number of avenues for future research. This study may provide an opportunity to persons with late-life chronic disorders to manage their health status more effectively in the future. This may be beneficial for planning purposes.

Procedures for Protection against Risk. Data safety monitoring board was assembled for all of the parent studies and the PI of this proposed study will regularly meet with Drs. Lingler and Bender to ensure the data are properly used and analyzed for scientific inquiry. The investigators of all

parent studies highlighted to participants that study participation is voluntary and will not affect clinical care at UPMC Health System or involvement with the University of Pittsburgh. Study participants were given the opportunity to refuse to participate in the studies. To minimize the risk of breach of confidentiality, unique numeric identifiers were used to each participant of all parent datasets. These files were stored under lock and key and will be accessed only by the PI and the research member. Identities of participants will not be revealed in publications or presentations derived from this project.

Importance of Knowledge to be Gained. Given the dearth of information about illness perceptions and self-management strategies in late-life chronic disorders based on the disease characteristics (physical vs. mental health conditions), the knowledge derived from this study will provide a new understanding of the self-management behaviors associated with one’s beliefs on their disease and symptoms. Findings from this proposed study may inform the future development of interventions to improve self-management of late-life chronic disorders in this population.

Inclusion of Women, Minorities and Children. Since almost 50% of our sample is women, we expect an approximately equal representation of men and women. The majority of participants of parent studies were Caucasian, which does reflect the racial and ethnic distribution of older population in Pittsburgh and the surrounding region. No individuals were excluded from participation based on race, gender, or medical conditions like HIV status. This proposed study will exclude children under the age of 18 because the purpose of this research is to examine illness perceptions and self-management strategies among persons with T2DM and MCI aged 50 and

older, which are age-related chronic physical and mental health conditions that do not affect children.