Clinical Research Directory

Personalized Routine and Habit Integration to Support Medication Management

The objective of this study is to test a multidisciplinary care team behavioral intervention to enhance medication adherence among older adults with multiple chronic conditions (MCC). The Personalized Routine and Habit Integration to Support Medication Management (PRISM) intervention is a novel, scalable intervention delivered by pharmacists and occupational therapists (OTs) that aims to improve medication adherence by reducing regimen complexity and solidifying medication habits within daily routines. The goal of this randomized control trial is to evaluate the effectiveness and implementation of PRISM compared with enhanced usual care.

Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors

As survival rates following breast cancer surgery continue to improve, long-term survivorship management has emerged as a crucial clinical priority. In particular, two major clinical challenges remain: (1) maintaining medication adherence to 5 to 10 years of adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) by actively managing treatment-related adverse symptoms, and (2) early detection and prevention of chronic breast cancer-related lymphedema following axillary lymph node dissection (ALND). Conventional passive monitoring relying on routine outpatient visits every 3 to 6 months often fails to detect daily symptom worsening or subclinical fluid accumulation in a timely manner. This single-center, prospective, open-label, parallel-group randomized clinical trial evaluates the efficacy of an Agentic AI-based digital healthcare application (Pinkmate; a non-medical mobile health app) and a home bioelectrical impedance analyzer (InBody BWA ON) across two independent cohorts under a single master protocol. This study is conducted at Seoul St. Mary's Hospital and supported by the National IT Industry Promotion Agency (NIPA; Grant No. PJT-25-050007). Dual enrollment is permitted for patients meeting eligibility criteria for both cohorts (total target enrollment: 264 participants). 1. Cohort 1: Medication Adherence and Active Symptom Management (N=200) Two hundred breast cancer patients initiating or receiving adjuvant endocrine therapy are randomized 1:1. The experimental arm receives weekly electronic patient-reported outcomes (ePRO), conversational AI chatbot-triggered symptom questionnaires, clinician dashboard alert flags, and proactive telephone calls from clinical staff within 48 hours of an alert. The control arm uses basic medication reminders/checklists and quarterly ePRO collection without proactive alerts. The primary endpoint is the Proportion of Days Covered (PDC) at 6 months. 2. Cohort 2: Early Lymphedema Monitoring and Management (N=64) Sixty-four breast cancer patients who underwent ALND (including newly operated patients and prior ALND patients without clinical lymphedema) are randomized 1:1. The experimental arm uses a loaned home InBody BWA ON device at least twice weekly linked to the Pinkmate app; persistent dashboard alerts (3 consecutive days) trigger proactive phone counseling and early clinic visit recommendations. The control arm undergoes routine outpatient surveillance using the in-clinic InBody 770 analyzer and tape measurements, along with educational self-care app content. In both arms, standardized rehabilitation therapy is initiated based on in-clinic InBody 770 and tape circumference measurements using identical criteria. The primary endpoints are the percentage change in affected upper limb volume and the change in affected-arm ECW/TBW ratio from baseline to 6 months post-enrollment.

The AYA Oncology Self-care Movement

This trial will test the impact of a social media intervention for improving oral chemotherapy adherence among adolescents and young adults (AYAs) with acute lymphoblastic leukemia.

Heart Rate Variability and Medication Adherence in Resistant Hypertension

This single-center, cross-sectional observational study examines the relationship between adherence to antihypertensive therapy - verified objectively by therapeutic drug monitoring (TDM) - and heart rate variability (HRV) in patients with resistant hypertension. Patients are recruited opportunistically, in a nurse-led manner, in a one-day-care cardiology unit, and undergo a single examination: a short-term HRV recording (Polar H10), a single blood draw for antihypertensive drug levels, office blood pressure, and self-completed questionnaires. There is no follow-up.

Investigation of a Patient Support Intervention for Statin Medication Adherence

Statins have been demonstrated to significantly reduce the risk of cardiovascular disease, but adherence to these medications is suboptimal. Improving adherence can be challenging because it is multifactorial and behaviors often occur within the everyday lives of patients and are less addressable during a visit with a clinician. In this study, the investigators will conduct a randomized trial to evaluate a behaviorally-designed gamification intervention with remote nursing support to improve statin adherence.

Smart About Meds (SAM) RCT

Introduction: Almost half of patients discharged from hospital are re-admitted or return to the emergency department (ED) within 90 days. Patient nonadherence to medication changes during hospitalization and the use of potentially inappropriate medications (PIMs) both contribute to the risk of adverse events post-discharge. Smart About Meds (SAM) is a patient-centered mobile application designed to target medication nonadherence and PIMs use. This protocol describes a randomized controlled trial (RCT) to evaluate the effectiveness of SAM. Methods \& Analysis: A pragmatic, stratified RCT will be conducted among 3,250 patients discharged from internal medicine, cardiac care, cardiac surgery, vascular surgery, and respiratory units of the Royal Victoria Hospital and the Montreal General Hospital. At discharge, patients will be randomized 1:1 to usual care or the SAM intervention. SAM integrates novel user-centered features (e.g. continuously updated medication list with pill images, side-effect checker, interaction checker) with pharmacist monitoring to tackle post-discharge nonadherence to new medication regimens. SAM also notifies patients of PIMS in their regimen, with advice to discuss with their physician. Following discharge, patients will be followed for 90 days, during which the occurrence of the composite outcome of ED visits, hospital readmissions, or death will be measured. Secondary outcomes will include the individual components of the composite outcome, nonadherence to medication changes, defined as failure to fill a new prescription, filling a modified prescription at the incorrect dose, or filling discontinued medications, secondary medication adherence, patient empowerment, and health-related quality of life. An intention-to-treat analysis will evaluate the effectiveness of SAM. Multivariable logistic regression will estimate differences between treatment groups in the proportion of patients nonadherent to at least one medication change. With a sample size of 3,250, there will be 80% power to detect a 5% absolute reduction in this outcome. Two-way interaction terms will test hypothesized modifiers of SAM's effectiveness, including hospital, unit, age, sex, gender and comorbidity burden. Binary and continuous secondary outcomes will be assessed using multivariable logistic and linear regression, respectively.

Early Prototyping and Usability Testing (ACPS)

The goal of this pilot clinical trial is to refine and test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. The main question\[s\] it aims to answer are: * How should the intervention be designed to best fit patients' needs and preferences? * Is an adaptive intervention (personalizing the intensity of support based on patients' needs) efficacious for promoting medication adherence Researchers will compare the adaptive intervention to automated text message reminders see if the adaptive intervention shows stronger positive effects on medication adherence.

Preventing Medication Mismanagement in People Living With Dementia Through Automated Medication Dispensing With Facial Recognition and Video Observation

Globally, \>47M individuals live with dementia, with new incidence of 7.7M annually. Medication mismanagement is one of the most common and concerning risk factors in people with dementia (PwD), as it leads to undertreatment, emergency room visits, hospital admissions/readmissions, and serious adverse events. 3M older U.S. adults are admitted to nursing homes due to drug-related adherence problems with costs \>$14B/year. Furthermore, 30% of hospital admissions of older adults are drug related with 11% attributed to medication non-adherence and 17% to adverse drug reactions. While Alzheimer's disease (AD) \& type 2 diabetes mellitus (DM) individually have considerable morbidity \& mortality, they often occur together, worsening adverse outcomes, quality of life, \& care costs. This is especially true as the AD/DM combination creates a complex balancing act of med management \& symptom monitoring in older populations. While the goal is to keep older adults with dementia at home as long as possible, these challenges lead to untold personal \& family suffering, as well as billions in potentially avoidable healthcare costs annually. The HiDO-ALZ platform will solve these challenges by automating medication administration for PwD to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place. HiDO is being developed as an automated, AI driven medication dispensing and direct observation platform to optimize adherence. The device integrates medication dispensing, dose administration time, medication synchronization, \& pair of front-facing cameras to validate the right meds, right route, right time, right dosage to the right patient (5R's). Cameras record every dose using facial recognition \& provide real -time medication consumption recordings. Through cloud connectivity, providers \& caregivers have access to video observation logs, dose administration time, adherence trends, \& longitudinal adherence via web dashboard. Patients \& caregivers can easily setup complex medication protocols in minutes using a smartphone app. The device then alerts patients and dispenses up to 7 different types of meds simultaneously, with up to 90 days of medication. Connected data sources including remote blood pressure and weight measurements, as well as electronic health record lab results and videoconferencing integrate in a single dashboard. The project will build on successful Phase I, in which the medication dispensing unit was updated with modifications for dementia, passed all bench testing, and was successfully validated in pilot usability with dementia subjects. Phase II will expand the foundation with four Aims: 1) Enhance device with remote sensors for diabetes management, expanded data integration, and video conferencing, 2) Test enhanced platform for usability in dementia subjects, 3) Transition the design to formal manufacturing process to ensure system meets performance standards and regulatory requirements \& produce pre-production devices for testing, \& 4) Conduct in-home clinical trial to demonstrate adherence and efficacy.

Medication Adherence Program

Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) \>=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.

The Effect of the 5th Sign Intervention on Medication Adherence in Kidney Transplant Recipients

The goal of this randomized controlled trial is to evaluate the effectiveness of the "5th Sign" intervention program-a multi-component strategy based on the Socio-Ecological Model that incorporates goal setting, action planning, medication education, problem-solving, and counseling, delivered via a custom mobile health application. The main questions it aims to answer are: * To examine the effect of the 5th Sign intervention on immunosuppressive medication adherence (measured biologically, via self-report, and mobile monitoring) in kidney transplant recipients. * To evaluate the effect of the intervention on clinical health outcomes, specifically including infection, mortality, Blood Urea Nitrogen (BUN) and creatinine levels, acute/chronic rejection, and graft loss. * To assess the effect of the intervention on the incidence of immunosuppressive drug-related side effects. Researchers will evaluate the 5th Sign intervention to see if the mobile health app and structured counseling are effective in improving medication adherence and patient outcomes. Participants will: * Be randomly assigned to either the intervention group (using the 5th Sign intervention) or the control group for a total study period of 6 months. * (If in the intervention group) Participate in active counseling and interviews for the first 3 months, followed by a 3-month monitoring period. * (If in the intervention group) Use the mobile health application continuously for 6 months for medication reminders and tracking, with their app usage evaluated on a monthly basis. * Complete questionnaires (regarding medication usage and side effects) and provide blood samples (to measure biological adherence and kidney function) twice: at the beginning of the study and at the end of the 6-month study period.

ECHO-COPD: Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention Among Chronic Obstructive Pulmonary Disease Patients

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease associated with substantial morbidity and mortality, impaired quality of life, and healthcare costs. Medication adherence and appropriate self-management are important components of COPD management; however, patients' health beliefs and perceptions may influence their adherence to treatment and engagement in recommended health behaviours. This study aims to evaluate the impact of a pharmacist-led educational intervention based on the Health Belief Model (HBM) on medication adherence, quality of life, and direct healthcare costs among patients with COPD receiving care at Buraidah Central Hospital (BCH) in Al-Qassim Region, Saudi Arabia. This study will use a quantitative, quasi-experimental pretest-posttest control-group design. Eligible COPD patients will be non-randomly assigned to either an intervention group or a control group. The intervention group will receive structured, pharmacist-led HBM-based educational sessions in addition to routine care. In contrast, the control group will receive standard care without additional education. Baseline assessments will include medication adherence using the Morisky Medication Adherence Scale-8 (MMAS-8); quality of life and health status using the COPD Assessment Test (CAT); health beliefs using a structured HBM questionnaire; and direct medical costs obtained from the hospital clinical cost centre. The educational intervention will be delivered over six months, followed by post-intervention assessment using the same outcome measures.

1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV

This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (BWLWHI) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g. self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component. The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV. Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline, 3-month and 6-month follow-up visits); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy (ART) prescription, medication adherence, and viral load status during 3-month and 6-month follow-up visits). Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.

A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer

The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their medications. The main questions the researchers are trying to answer are: * Does the tailored intervention increase adherence? * Does the tailored intervention improve quality of life? * Does the tailored intervention reduce health care utilization? The researchers will compare the tailored intervention to a uniform standard of care intervention (an intervention designed to be similar to what is currently happening in clinical care) to see if the tailored intervention works to improve adherence. Participants will: * Use an electronic pill bottle or box to store their medication * Participate in intervention sessions * Complete surveys before the intervention, after the intervention, and 6-months later

Structured Nursing Intervention for Adults With Poorly Controlled Asthma: A Pilot Study

Asthma affects a large number of adults, and many of them do not achieve good control of their symptoms. Poor inhaler technique, irregular medication use, and the lack of structured nursing follow-up are among the main reasons. RESPiraIA-Asma is a 12-month structured nursing intervention designed to address these gaps in adults with poorly controlled, non-severe asthma. This is a quasi-experimental, single-group, before-and-after pilot study. Each participant is followed across six visits over one year, at baseline and at months 1, 3, 6, 9, and 12. The intervention combines therapeutic education, inhaler technique training, home peak-flow self-monitoring, biopsychosocial assessment, and a standardized nursing care plan based on internationally recognized nursing taxonomies for diagnoses, interventions, and outcomes: NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC), activated by objective clinical thresholds. A central principle of the model is digital equity: the same standard of care is offered through three equivalent access routes (digital, mixed, or in-person), chosen according to each participant's digital skills, resources, and preferences, so that technology never becomes a barrier to access. The study evaluates whether the model is feasible to deliver in routine clinical practice, measured through participant retention, data completeness, and acceptability, and it looks for preliminary signals of its effect on asthma control, treatment adherence, lung function, and biopsychosocial well-being. As an exploratory pilot, it is not designed to confirm efficacy; its purpose is to inform the design of a larger future trial.

FEAR of HYPOGLYCEMIA in PATIENTS WITH DIABETES

Fear of hypoglycemia has a significant impact on both medication and dietary adherence in individuals with diabetes. Through avoidance behaviors, it can disrupt metabolic control, prevent the achievement of glycemic targets, and increase the risk of long-term complications. Therefore, monitoring only biochemical parameters is insufficient in diabetes management. It is crucial for healthcare professionals to systematically assess the fear of hypoglycemia.

Evaluation of an Instructional Video About Medication Management During Admission and Medication Adherence for Kidney Transplantation and in the Outpatient Clinic in a Dutch University Hospital.

The goal of this RCT is to evaluate the effect of the instructional video on improving patient compliance and reducing medication errors. The study will include adult kidney transplant recipients (18 years or older) at Erasmus MC who have undergone a kidney transplantation starting January 2026. The main questions it aims to answer: The primary aim of this study is to assess whether our developed video instruction, compared with the traditional verbal instruction, both of which are given shortly before training during admission, reduces the number of medication errors in kidney transplant patients. The study will also examine the correlation between patient characteristics (such as age, comorbidities, and language proficiency) and medication errors. Additionally, patient-reported medication errors will be measured through a questionnaire completed during follow-up visits at the outpatient clinic, which is part of standard care. The instructional video will be evaluated by a short questionnaire.

MHealth Incentivized Adherence Plus Patient Navigation

Polysubstance use involving opioids and methamphetamine is emerging as a new public health crisis. Patients with opioids and methamphetamine use often experience serious medical complications requiring hospitalization, which provides an opportunity to offer addiction treatment. Yet linkage to outpatient treatment post-discharge is suboptimal and methamphetamine exacerbates outcomes. The investigators propose to pilot test "MHealth Incentivized Adherence Plus Patient Navigation" (MIAPP) to promote treatment linkage and retention for patients with opioid use disorder (OUD) and methamphetamine use who initiate buprenorphine in the hospital. The investigators Aim is to perform a two-arm, pilot randomized clinical trial (n=40) comparing MIAPP + treatment-as-usual (TAU) versus TAU alone on outpatient medication for opioid use disorder (MOUD) linkage within 30 days (primary) and 90-day retention on medications (secondary) among hospitalized patients with OUD and methamphetamine use.

AI-Enabled Smartwatch for Medication Adherence in Outpatient Psychiatry

Medication nonadherence remains difficult to measure objectively in psychiatric care. This completed, single-center exploratory randomized trial evaluated whether four weeks of AI-enabled smartwatch medication monitoring improved clinician-rated medication adherence compared with waitlist usual care in psychiatric outpatients aged 12 years or older, predominantly adolescents and young adults with mood disorders.

Medication Collaboration Feasibility Study

This study examines the feasibility and acceptability of a brief medication collaboration intervention among older adults (age 60+) with early-stage dementia or mild cognitive impairment who take multiple medications and their family caregivers. The main aims are to: 1) determine the feasibility and acceptability of the intervention for older adults with early-stage dementia and their family caregivers, and 2) explore the effects of intervention on medication collaboration, medication adherence, and beliefs about dementia and autonomy. In this study, participants will: 1) complete a 15-30-minute baseline interview (by Zoom or phone), 2) participate together in a 45-60-minute virtual intervention led by an interventionist that includes: Assessment of medication responsibilities and beliefs. Education about dementia and medication management. Cognitive restructuring to address beliefs about independence and caregiver assistance. Collaborative planning for medication responsibilities and routines; and lastly 3) complete a 15-20-minute one-month follow-up interview (by Zoom or phone) to assess the intervention's acceptability and changes in medication management outcomes.

Impact of Online Medical Misinformation

A cross-sectional analytical study was conducted among adult patients diagnosed with chronic diseases to assess the impact of online medical misinformation on medication adherence, treatment decision-making, and health care-seeking behavior.

Medication Adherence in Patients With Sarcoidosis

The goal of the study is to look at the relationship between how individuals with Sarcoidosis take the sarcoidosis medicines and how it affects the disease, to evaluate any factors that may make individuals not want to take the medicines, and to develop and refine ways to help support individuals with Sarcoidosis especially when it comes to the medicines. The overall hypothesis is higher medication adherence will be associated with better clinical outcomes in sarcoidosis. The investigators will enroll 150 patients with biopsy proven pulmonary sarcoidosis for at least one year who are on any oral treatment regimen for at least six months into a 12-month longitudinal study.

System Usability of the MedTracks App to Aid Medication Adherence

This project aims to examine whether the MedTracks app is useful and easy to use for a cohort of adults taking two or more oral medications. It will also aim to indicate if use of the app changes attitudes and improves self-reported medication adherence. Qualitative interviews will be conducted with a sub-set of participants to examine issues in greater depth.

Improving Hypertension Medication Adherence for Older Adults

This randomized controlled trial will assess the efficacy and scalability of a blood pressure technology system intervention. The investigators will enroll 224 older adults with hypertension to identify those who are nonadherent for one hypertension medication. The participants will be randomized to one of two groups (112 per group) to use the blood pressure system for 6-months. Both groups receive information about high blood pressure and medications. One group will also receive strategies that can be used to take medications and manage blood pressure. Both groups will complete a mid-assessment at 3-months and a post-assessment at 6-months.

Effect of Digital Follow-up Supported Patient Education on Immunosuppressive Medication Adherence and Quality of Life After Liver Transplantation

This randomized controlled study aimed to evaluate the effect of digital follow-up supported patient education on immunosuppressive medication adherence and quality of life in adult liver transplant recipients. Participants in both groups received standard discharge education. The intervention group additionally received structured digital follow-up messages for 12 weeks, while the control group received standard care only. Medication adherence and quality of life were assessed before and after the intervention using validated questionnaires.