Clinical Research Directory

Improving Health and Wellness for People With Serious Mental Illness in Puerto Rico

This study evaluates the effectiveness of a culturally tailored intervention, Bridges to Better Health and Wellness (BRIDGES), aimed at reducing chronic disease disparities among Puerto Ricans with serious mental illness (SMI). Participants receive monthly sessions with health care managers to address patient-provider stigma and care coordination.

Evaluation of the Effectiveness and Implementation of the BETTER Women Peer Health Coaching Program

The Building on Existing Tools To improvE cancer and chronic disease pRevention and screening in primary care (BETTER) Program allows patients in primary care to have a dedicated visit with a prevention practitioner to discuss chronic disease prevention and cancer screening. A prevention practitioner is a health professional, working in primary care, who has received additional training to discuss chronic disease prevention and screening and develop health goals with patients through shared decision-making. Previous studies have shown that this approach increases the number of prevention and screening actions completed by program participants. However, maintenance of health behaviour changes is difficult without on-going support. There is also some evidence that peer-delivered coaching can improve health outcomes in community settings. As such, the BETTER Women program extends the BETTER program by focusing on 40 to 68-year-old women and providing time-limited support for health behaviour change through peer health coaches. Coaches are volunteers - trained in techniques to support health behaviour change - who support women to achieve their health goals over a 6-month period. In this study, the investigators will explore: (i) whether patients who participate in health coaching after a prevention visit are more likely to increase the number of prevention and screening actions that they complete after six months, compared to women who participate in a prevention visit but do not get health coaching; (ii) whether the intervention effects endure six months after the intervention ends; and (iii) the implementation of the program to learn about factors that affect various aspects of the success and sustainability of the program.

A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions

Among people who do not want to get pregnant, some do not use any birth control. This is also called contraceptive nonuse. Common reasons for contraceptive nonuse include concerns about birth control safety or side effects. People with health conditions, such as diabetes or high blood pressure, also report worries about how different birth control methods might affect their health condition or medicines. The goal of this clinical trial is to learn if a web tool called My Health, My Choice helps people with health conditions understand their birth control options and choose birth control that is right for them. The study will also look at the medical safety of birth control methods that participants decide to use. The main questions it aims to answer are: • Does the My Health My Choice tool lower the number of participants who do not use any birth control method? (contraceptive nonuse) In other words, does the My Health My Choice tool increase the number of participants who use any birth control method? (contraceptive use) Participants who use the My Health, My Choice tool before a clinic visit with their clinician (Intervention Group) will be compared to participants who only go to a clinic visit with their clinician (Usual Care Group). For this study, a "clinician" is any licensed health care provider who counsels about birth control, prescribes birth control, and/or inserts birth control devices. All participants will: * Complete 4-5 online surveys that take 5-10 minutes each, over a 3 month time period * Be asked to go to a scheduled clinic visit with their health care provider * A small group of participants (about 30) will be invited to a 1 hour exit interview Participants in the intervention arm will be asked to: • Use the My Health My Choice tool before their clinic visit

Psychological Adjustment to Long-term (PAL) Physical Conditions: A Randomised Cross-over Feasibility Trial of a Self-guided App

This study is a two-arm, randomised controlled cross-over feasibility study with a nested, optional qualitative study. The intervention consists of a self-guided smartphone app (Orbi) based on cognitive behavioural therapy (CBT) principles, which is designed to support psychological adjustment in long-term physical conditions. Orbi is an app adaption of an existing, evidence-based web-based intervention COMPASS. The control condition consists of usual charity support (UCS) for the relevant long-term physical health conditions (LTCs). All charity support includes a helpline which can be accessed via telephone or email. The goal of this trial is to evaluate the feasibility of Orbi and the main questions it aims to answer are: 1. Is Orbi a feasible and acceptable intervention for individuals experiencing psychological distress related to LTCs? 2. Which aspects of the Orbi app and the trial enhance or diminish participants' experiences? Participants will: * Be randomised and each participant has an equal (50 %) chance of being assigned either to the Orbi+UCS group or to UCS group alone for 12 weeks. After 12 weeks, they will be crossed over to the alternate condition for another 12 weeks * Complete questionnaires to assess psychological distress and intervention engagement at baseline, 6 weeks, and 12 weeks. * A subset of participants will be invited to take part in a nested, optional semi-structured interviews to explore their experiences using Orbi and participating in the study.

Families Implementing Good Health Traditions for Life

This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.

ECHO for Diabetes and Multiple Chronic Conditions Study

Diabetes mellitus is a chronic condition that affects the body's ability to process sugar effectively, which over time can increase the risk of heart disease, high blood pressure, and kidney damage. Other chronic conditions include high cholesterol, obesity, and depression. Persons with diabetes mellitus and multiple chronic conditions (DMMC) face higher risks of losing physical or mental function, experiencing other chronic conditions, and death. Most of the residents of New Mexico (NM) belong to groups at risk for developing DMMC. Finding quality healthcare is a key factor, as NM also ranks among the largest, poorest, and most rural states. Primary care providers (PCPs) most often treat DMMC patients, but healthcare teams can lack confidence in managing these complex patients and struggle to keep up with recommended guidelines. This Project ECHO model (ECHO) for DMMC, a telehealth intervention for healthcare teams, can lead to lower blood sugar levels in DMMC patients being treated at NM primary care clinics. ECHO is a "telementoring" program that trains healthcare teams to provide specialized medical care at their local clinics. This is done by connecting healthcare teams with specialist mentors at academic medical centers through videoconferencing sessions. During ECHO program sessions, groups of healthcare teams hear lectures on key topics in DMMC care from experts, and then give presentations of anonymous patient cases by a healthcare teams for discussion and to receive recommendations. This clinical pragmatic trial aims to learn if the intervention will improve patient blood sugar levels in persons with DMMC who are being treated at selected health clinic sites throughout New Mexico. The study aims to answer: * Whether a 0.5% drop in HbA1c on average can be achieved in the group whose healthcare teams are receiving the ECHO intervention compared to the comparator group, whose providers will not receive the intervention. * Whether the rate of an individual's HbA1c was greater than 8.5% at the baseline will be reduced by 15% at the end of the intervention. Researchers will compare health data for patients empaneled to healthcare teams in the study and the usual care comparator group both before and after the intervention period to see whether the ECHO model has a positive influence on test results.

Comparative Effectiveness of IIMR Versus CDSMP

The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population.

Impact of a Mobile Application-Based Medication Reminder on Treatment Adherence Among Patients With Chronic Diseases and Memory Impairment: A Nursing Leadership Perspective

This study aims to evaluate the impact of using a mobile application-based medication reminder on medication adherence among patients diagnosed with chronic diseases and memory impairment. Adherence to prescribed therapy is a significant challenge for this patient population, often leading to poor health outcomes and increased healthcare costs. From a nursing leadership perspective, innovative digital solutions can play a crucial role in supporting patient self-management. Using a quasi-experimental design, the study will investigate whether a customized mobile reminder system can effectively improve adherence rates and support patients in managing their therapeutic regimens.

Evaluation of AI Cost Prediction Model to Enroll Patients in Complex Care Management Program

Currently, UCLA Health (specifically the Office of Population Health and Accountable Care, or OPHAC) runs a complex care management program called Proactive Care (goal is to reduce care utilization by providing personalized care navigation/case management). Every month, an AI Population Risk tool runs to identify around 250 of the 480,000 or so UCLA primary care patients, and RNs contact these 250 patients to enroll in Proactive Care. Starting in December 2024, OPHAC launched a new method of enrolling UCLA's Medicare Advantage (MA) patients into Proactive Care: an AI Cost Prediction model. The idea is the same-- the top 250 highest predicted cost patients will be enrolled in Proactive Care. The investigators will evaluate this model and subsequent enrollment into the program by randomizing the waitlist of MA patients waiting to enroll in Proactive Care, thereby creating a control group. The top 500 highest predicted cost patients will be identified each month, and following a 1:1 randomization, 250 will be contacted for enrollment and the rest will be put on a wait-list control group for 10 months unless otherwise requested by their provider to be enrolled in the Proactive Care program earlier.

Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients

As the general population ages and technology advances, many who suffer from catastrophic critical illness (i.e. septic shock, respiratory failure, Acute Respiratory Disease Syndrome) survive only to find themselves severely physically debilitated and compromised from a pulmonary standpoint, requiring assistance from a mechanical ventilator in order to breath. Oftentimes, these patients require a long course of physical rehabilitation and ventilator support. These patients frequently remain ventilator dependent for greater than 3 weeks, and are thus referred to as requiring prolonged mechanical ventilation (PMV). Older patients are at significantly higher risk for requiring PMV for reasons that are not entirely clear, but which may include physical deconditioning, impaired cardiopulmonary physiology, and cognitive or behavioral disturbances. The purpose of this study is two fold: 1. to characterize the functional phenotype of ventilator dependent, and recently ventilated patients with respect to general strength, endurance, balance, and pulmonary functioning and body composition. 2. To pilot test a rehabilitation protocol that targets improving this populations disabilities through exercises focused on improving strength, endurance, balance, and pulmonary functioning.

Social Risk Score, Clinical Decision Support Tool and Closed Loop Referral for Social Risk Screen and Referral

The overarching goal of this project is to leverage health information technology (HIT) to integrate available digital information on social needs to improve care for racial and ethnic minorities and socially disadvantaged populations with chronic diseases. In the previous phases of this project the investigators developed a social risk score to identify social needs among medically under-served patients with special emphasis on application among African American patients with low income and chronic diseases who face social determinants, risk factors, and needs (SDRN) challenges. The investigators also developed a clinical decision support (CDS) tool to present the social risk score to clinical providers and sought feedback from different users on the face and content validity of the CDS tool. In the current project the investigators will run a randomized clinical trial (RCT) study to pilot test the new risk score and CDS tool in selected primary care clinics at Johns Hopkins Health System (JHHS) and in collaboration with selected community-based organizations (CBOs). This system will help identify, manage, and refer patients with both high levels of disease burden and modifiable SDRN challenges.

Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis

Uveitis and its complications are thought to account for 10 to 15% of preventable blindness in Western countries. The diagnosis of chronic non-infectious uveitis (CNUI) can be made after exclusion of pseudo uveitis or infectious uveitis, in the case of any persistent uveitis or uveitis with frequent relapses occurring less than 3 months after cessation of treatment. Adalimumab (ADA), an anti-TNFα monoclonal antibody, has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids. The use of ADA has been optimized, in particular through Therapeutic Drug Monitoring (TDM), based on the determination of serum ADA levels and anti-ADA antibodies. Recently, an article showed that a strategy of spacing ADA administrations in RA patients with concentrations \>8 μg/mL was not inferior to standard.

Itaca App vs. Usual Care for Medication Adherence in Older Adults on Polypharmacy

The goal of this clinical trial is to learn if the use of a mobile app called Itaca improves medication adherence in older adults (aged ≥65) in a home care setting. It will also assess the impact of the app on patient engagement, patient activation, quality of life, and the app's usability in the intervention group. The main question it aims to answer is: * Does the use of the Itaca mobile application improve medication adherence among older adults in the home care setting compared with usual care? * Does the use of the Itaca mobile application improve patient engagement, patient activation, and quality of life among older adults in the home care setting compared with usual care? Researchers will compare usual care to see if the intervention using the Itaca mobile app is more effective in improving medication adherence. Participants will: * In the intervention group, use the Itaca app for 3 months * In the intervention group, receive monthly phone calls to support adherence to the study protocol, monitor app use, and address any barriers * In the intervention group, complete the usability scale at the end of the 3-month intervention period * In both the intervention and control groups, complete the questionnaires at enrollment and after 3 months, at the end of the intervention period

Housing, Environment, And Living Conditions for Transformed Health

This project will compare the health effects of public housing renovation, neighborhood built and social environment improvements, and indoor air purification, alone and in combination, as well as the cost effectiveness of each approach. STUDY 1: The study will assess the effects of public housing and neighborhood environment (built and social) improvements on health-related behaviors, psychosocial and physiologic stress, and self-reported and physiological markers of lung health and chronic disease. STUDY 2: The study will determine whether indoor air purification can positively impact lung health in public housing sites not undergoing housing renovation, comparing a site near industrial pollution vs one less contaminated.

Antecedent Metabolic Health and Metformin Aging Study

Aging is the number one risk factor for the majority of chronic diseases. There are no pharmaceutical treatments to slow aging and prolong healthspan. The anti-diabetic drug metformin is considered a likely pharmaceutical candidate to slow aging. In this study, the investigators hypothesize that metformin treatment in subjects free of type 2 diabetes will improve insulin sensitivity and glucoregulation in insulin resistant individuals, but will decrease insulin sensitivity and glucoregulation in insulin sensitive subjects. Further, the investigators hypothesize that long-term metformin treatment will remodel mitochondria in a way that decreases mitochondrial function in subjects that are insulin sensitive, but improves mitochondrial function in subjects that are insulin resistant. The investigators will use a dual-site, 12- week drug intervention trial performed in a double-blind, placebo-controlled manner on 148 subjects recruited from two separate sites (Oklahoma Medical Research Foundation (OMRF) and University of Wisconsin-Madison (UWM)). After consent and initial subject screening for chronic disease, subjects will be stratified to insulin sensitive (IS) or insulin resistant (IR) groups. Over a 12- week intervention, half of each group will take metformin and half will take a placebo. Pre- and post--intervention, subjects will complete a series of procedures to assess insulin sensitivity, glucose regulation, and biomarkers of aging. The same subjects will provide a skeletal muscle biopsy pre-- and post-intervention to assess the change in mitochondrial function and mitochondrial remodeling with and without metformin treatment. By completion of this project, the investigators expect to provide evidence that helps further delineate who may benefit from metformin treatment to slow aging.

Improving Patients' Adherence to Their Chronic Treatments by Implementing a Simple, Standardized and Redundant Message Delivered by Healthcare Professionals.

The primary objective in this study is to achieve a 15% 6-month improvement in therapeutic adherence among patients with chronic pathologies, thanks to a simple, standardized and redundant message delivered by healthcare professionals during consultations/interviews Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action concerning therapeutic adherence. This message is delivered with the aim of modifying the patient's behavior with regard to treatment intake.

Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers

The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.

Burden of Care and Health Literacy of Caregivers in the Emergency Department

This study aims to investigate the relationship between caregiver burden and health literacy among primary caregivers of patients with chronic diseases presenting to the emergency department. The study will be conducted in the Emergency Department of Yalova Training and Research Hospital and will include at least 300 caregivers. Data will be collected using a sociodemographic questionnaire, the Turkish Health Literacy Scale-32 (THLS-32), and the Zarit Burden Interview (ZBI). The findings are expected to contribute to a better understanding of caregivers' needs and to clarify the role of health literacy in caregiver burden among those providing care for individuals with chronic illnesses.

Training Community Members to be Coaches to Deliver the HealthyLifetime Program

The goal of this randomized controlled study is to learn if, in addition to nurses, community members can be trained as health coaches to deliver the HealthyLifetime (HL) program to people without complex chronic health conditions, an intervention that provides a short-term and effective health coaching intervention delivered through a virtual platform to improve health, resiliency, and independent self-care to participants who are without complex chronic conditions. The main question it aims to answer is: • Can Community Health Coaches achieve the same level of competency and outcome as Nurse Health Coaches in participants without complex chronic conditions?

Generative AI for Medication Counselling and Adherence in Community Pharmacies

Medication counseling within community pharmacies is crucial for managing chronic diseases, yet significant challenges regarding correctness and completeness remain in Jordan. Although generative artificial intelligence (AI) can be utilized for patient education, there is a lack of research on clinical impact and safety of AI in medication counseling conducted by pharmacists in real-world practice. The aim of this study is to evaluate the effect of pharmacist-supervised AI-assisted medication counseling on the correctness and completeness of counseling information and 30-day medication adherence among patients in Jordanian community pharmacies.

Impact of an Intervention Integrating the MPHS Nursing Model of Care on the Partnership in Health, With the Patient Followed in Primary Care by an Advanced Practice Nurse (APN) for One or More Stabilized Chronic Pathologies

The WHO and our governance advocate that health professionals should organize care around the patient, considering his or her values, needs and preferences, and enabling the patient to develop the capacity to self-manage the chronic health problems he or she faces. Chronic disease is an ongoing dynamic process and adaptation to this process is complicated by the interaction of several determinants: self-management capacity, level of health literacy, quality of life and experience of care. To best support chronic disease, the recommendation is to adopt a management strategy that allows chronic patients to play an active role in the management of their condition and in the day-to-day decision-making process. The management of chronic pathologies is one of the specialties in which Advanced Practice Nurses are positioned, in primary care, outside hospital. Nursing care benefits from care models that allow for more adapted responses, regarding particular care situations, or certain patient typologies. The Humanistic Partnership Health Care Model (MPHS) implement in current Advanced Practice Nurse (APN) practice.

Digital Literacy of Chronic Heart Failure Patients

A retrospective cohort study was conducted using a web application (Satelia®Cardio by NP Medical) for the management of chronic heart failure. Patients were categorized according to digital literacy (digitally literate versus poor digital literacy).

Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program

Since 2009, a programmatic community-based strategy (COPE) has been implemented to address health disparities among Navajo individuals living with multiple chronic conditions. COPE (Community Outreach and Patient Empowerment) targets individual, family, and health system-level factors through four activities: 1) coordination between community health representatives (CHRs) and Indian Health Service providers; 2) CHR competency with standardized training; 3) a culturally-sensitive health promotion curriculum for patients and families; and 4) strong CHR supervision. COPE has been implemented throughout Navajo Nation. Enrollment is programmatic; in other words, the decision to enroll a patient in COPE occurs independently of whether the patient is in this study. Participants receive the COPE intervention in the same manner and intensity, whether they are included in this observational study or not. The main goal of this observational research is to understand if COPE improves the lives of participating community members. The Primary Aim is to assess the impact of the COPE Project on changes in HbA1c and other CVD risk factors. Hypothesis: Patients enrolled in the COPE program will experience a reduction in HbA1c compared to the control group. Secondary aims are: 1) To understand if COPE improves patients' own self-reported outcomes. Hypothesis: COPE patients will report better health compared with their own baseline at 12 months. 2) To Identify factors associated with increased effectiveness of the COPE Project at the individual, community, and health system level using a mixed-model approach. 3) To understand diverse stakeholder perspectives on COPE impact and value among CHRs, providers and the health care system. Hypothesis: Compared with baseline, CHRs will report greater empowerment in their work, providers will report greater confidence in CHRs. The observational cohort will be comprised of individuals with diabetes receiving care at one of the participating health facilities. Cases include individuals participating in the COPE intervention; controls are non-COPE participants identified within the same hospital and matched based on similar baseline characteristics. Study findings will improve clinical and patient-decision making and the health of marginalized AI/ANs by informing policies to promote CHR interventions in rural and underserved communities.

Development and Evaluation of an Online Shared Decision-Making Educational Program for Nurses and Patients With Chronic Diseases

This study aims to develop and evaluate an online shared decision-making (SDM) educational program for nurses and patients with chronic diseases. Shared decision-making is a process in which healthcare professionals and patients make health-related decisions together based on the best available evidence and the patient's values and preferences. The study includes an evaluation phase. In the evaluation phase, the program will be tested among nurses working in general hospitals and adults with chronic diseases living in the community. Outcomes related to shared decision-making will be assessed at baseline, immediately after the 4-week program, and 1 month later. The study is expected to improve shared decision-making competence, experience, and preparedness among both nurses and patients.