25 Clinical Trials for Various Conditions
This is a randomized trial testing a peri- and post-discharge pharmacist-led medication management intervention on post-discharge utilization, including both readmissions and emergency department visits within 30 days of discharge. The intervention incorporates evidence addressing three main areas: medication reconciliation, medication adherence, and polypharmacy. This study uses a pragmatic trial randomized at the patient level and conducted in two large hospitals to achieve the following aims, each of which has been designed using the RE-AIM framework: Aim 1: To test the effect of PHARM-DC on post-discharge utilization among patients most at risk for post-discharge ADEs: recently discharged older adults taking \>10 medications or \>3 high-risk medications using a prospective, randomized, pragmatic multi-site study. Aim 2: To study barriers and facilitators of implementing PHARM-DC using a qualitative study. Aim 3: To analyze the costs of PHARM-DC, including the incremental cost per readmission averted and the net incremental cost from the health system perspective using a time-and-motion study and a cost-effectiveness analysis.
Hypertension is the leading risk factor for cardiovascular disease, global mortality, and ranks third among the causes of disability. Treatment of hypertension is relatively straightforward, but patient adherence to long-term self-care strategies is problematically low. Three important behaviors that individuals can adhere to in order to help lower their BP are 1) Taking medications as prescribed by a physician, 2) Monitoring BP at home, and 3) Limiting dietary sodium intake. Adherence to these behaviors is problematic and currently ranges from 25% to 50%; the present Phase I STTR study is aimed at addressing the behavioral barriers for adherence to these three activities with the help of mobile technology. In particular, this STTR will develop and test an incentive program delivered through a mobile health app to increase adherence to prescribed BP control regimens and precipitate reduction in BP.
This study evaluates the ability of digital medicines, Proteus Discover, to promote adherence and thus achieving a cure for hepatitis C in patients at high risk for not adhering to their hepatitis therapy. In this single-arm, prospective study, subjects at high risk for nonadherence will be prescribed hepatitis C therapy that will be co-encapsulated with ingestible sensors (creating the digital medicine) by a pharmacy. Both the subject and the providers will have access to the ingestion adherence.
Behavioral obesity treatment (BOT) produces clinically significant weight loss and health benefits for many individuals with overweight/obesity and cardiovascular disease (CVD). Yet, about half of patients fall short of expected outcomes and most experience gradual weight regain, thus negating the benefits over time. Lapses (i.e., self-reported eating instances that deviate from the BOT prescribed diet) could explain poor outcomes, but the behavior is understudied because it is difficult to assess in-lab and via self-report. The investigators therefore propose to study lapses using a multimethod approach with the following tools: ecological momentary assessment (EMA; repeated sampling method via mobile device), a wrist-worn device that automatically detects eating behavior and various eating characteristics (frequency, rate, and duration of eating episodes), and 24-hour dietary recalls. The investigators will recruit participants (n=40) with overweight/obesity and one additional CVD risk factor to enroll in a 12-week BOT program and an additional 12-week period of weight loss maintenance. Participants will complete a biweekly 7-day EMA protocol to self-report on eating behavior, including the occurrence of dietary lapse. Participants will continuously wear the wrist-worn ActiGraph Link to characterize eating behavior. Lastly, participants will complete 24-hour dietary recalls via structured interview (split between days with and without lapses) at 6-week intervals to measure the composition of all food and beverages consumed. This study aims to 1) identifying characteristics of lapse behavior by measuring passively-sensed timing, duration, frequency, and rate of eating amongst known lapse episodes, 2) test the association between dietary lapse frequency and weight change, and 3) estimate nutrition composition of dietary lapses. The study approach is consistent with priorities of NHLBI to optimize clinical research and diagnostic strategies to improve CVD and related risk factors.
Feasibility study of using a digital health feedback system (DHFS) to monitor medication-taking and physiologic and behavioral parameters in patients with bipolar disorder or schizophrenia. Hypothesis: Using a digital health feedback system to characterize medication-taking behavior and activities of daily living is safe and tolerable in appropriately selected patients with bipolar disorder and schizophrenia.
This study is a modular intervention that is intended to improve treatment adherence among individuals with bipolar disorder on atypical antipsychotic therapy who have been identified as having treatment adherence problems.
In this study, patients with bipolar disorder who do not take their medications as prescribed will receive specialized education and therapy treatment to determine whether the specialized treatment is effective in helping patients to take their medications consistently.
This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them.
Hypertension affects nearly 50 million Americans \[1\] and is the most common chronic condition among veterans. Unfortunately, many patients with established hypertension have poorly controlled blood pressure (BP); control rates in the VA are at approximately 70% currently. While clinician failure to aggressively manage hypertension through therapeutic intensification (clinical inertia, or failure to intensify pharmacotherapy appropriately) contributes to poor blood pressure control, even when doctors do intensify therapy, 43-78% of patients fail to adhere to recommended therapies, indicating that adherence remains a central problem in hypertension care. This suggests important opportunities for interventions to improve risk factor control by working through clinicians, their teams, or their delivery systems, as well as with patients, to address both patient adherence and clinical inertia.
Efficacious antipsychotic medication treatments for schizophrenia are available; however , antipsychotic regimens frequently do not achieve their potential because of poor medication adherence. To date, medication adherence interventions have not been widely adopted or sustained in "real-world" practice settings. One reason for this is the substantial resource investment necessary to implement and sustain available interventions. In response to these problems, we developed a patient-centered adherence intervention based on patient-identified barriers, facilitators, and motivators (BFMs) for medication adherence. The intervention includes a BFM survey (checklist and preference weighting exercise to determine the patient's most important BFM) and a brief list of adherence enhancing suggestions (Options List) tailored to the patient-identified BFMs and compatible with CPRS. The long-term objective of this proposed research is to improve antipsychotic medication adherence and clinical outcomes for patients with schizophrenia using a cost-effective medication adherence intervention. The short-term objectives are to refine and test a patient-centered medication adherence intervention for VA patients with schizophrenia and specifically to: 1. Enhance the feasibility and acceptability of the BFM intervention by reducing the burden on patients and mental health providers through BFM checklist item reduction, provider intervention input, and patient intervention input. We hypothesize that our use of end-user input will result in at least 80% of intervention patients having documentation of a BFM intervention in CPRS. 2. Compare the effects of the BFM intervention versus usual care on changes in medication adherence and schizophrenia symptom severity. We hypothesize that the intervention will result in a) greater medication adherence and b) lower schizophrenia symptom severity than usual care. 3. Exploratory objective: compare the effects of the BFM intervention versus usual care on changes in patient health-related quality of life. We hypothesize that the intervention will result in greater health-related quality of life than usual care.
Liquid medication administration errors are common, and place children at risk for adverse events. Caregivers with low socioeconomic status (SES), low education and poor health literacy skills are at increased risk for errors. In this study, we seek to assess whether at-risk parents who received a plain language, pictogram-based intervention would have reduced medication dosing errors and improved medication adherence.
Our research aims to improve the use of medicines known to prevent recurrent heart attacks. In particular, we know that statin treatment is useful after heart attacks, but many patients do not use it. There are a few possible reasons for this. Patients cannot find affordable medicine. Their doctor may not prescribe the medicine after they leave the hospital. Some people may culturally mistrust using the medicine. So they may decide not to take it even if it is prescribed. We are developing a hospital based culturally attuned program to target this problem. In this program, a community health worker counsels and helps patients in accessing pharmacy assistance programs. We will test whether this program can improve appropriate statin use. We will enroll patients who have heart attacks. We will compare patients who are counseled by the community health worker with those who get the usual care at baseline and at 6 and 12 months (participants enrolled during the early phase of the recruitment will have an additional study visit at 24 months). We will test if their "bad" cholesterol levels are controlled. We will find out how regularly they have filled their questionnaire and taken the medicine. Finally, we will test if they are getting benefit from the statin treatment. We will do this using blood tests and imaging the patients' arteries with ultrasound. We will also measure how cost-effective it is for a hospital to run the program. It is our goal to develop a community health worker model that is culturally sensitive for people with cultural, educational or educational barriers. Statin use is known to benefit patients in theory; such a culturally competent program will improve health outcomes in practice. After we test it, a cost-effective program such as this can be implemented in other hospitals.
This study has two objectives: 1. To assess the association between nintedanib adherence trajectory group (as measured from a Group-based Trajectory Modelling (GBTM)) and health care resource use, with a focus on inpatient hospitalization, among patients with Idiopathic Pulmonary Fibrosis (IPF). 2. To assess the association between a patient's nintedanib adherence trajectory group (as measured from a GBTM) and their medical costs among patients with IPF.
This will be a two--arm Randomized controlled trial (RCT) design that will assess efficacy of the Smartphone Medication Adherence Stops Hypertension (SMASH) mobile health ( mHealth) program compared to an enhanced standard care (SC) program. Participants will be African-American (AA) hypertension patients with no other known chronic diseases. Participants found to have uncontrolled hypertension (HTN) and medication non-adherence via electronic device monitoring will be randomized to SMASH or enhanced Standard Care (SC). The SMASH group will receive reminders in the form of auditory and visual reminders from a pill monitoring device when their medication dose is due, they will monitor their blood pressure at home and will receive tailored motivational text messages based upon levels of adherence . Enhanced SC group will use the pill monitoring device without reminder functions enabled and will receive text messages on topics of healthy lifestyles not related to medication adherence and hypertension. The active intervention will continue for 6 months and follow-up will continue for 1 year.
AiCure uses artificial intelligence and visual recognition technology to confirm medication ingestion. The software is available as an app and downloaded onto a smart phone. The single-site, parallel-arm, randomized controlled trial will test the feasibility and impact of using the platform in a stroke population. End points: usability, consistent use of the device, and optimization of treatment.
The main objectives of this research are: 1. To identify factors that influence medication adherence rates in Emergency Department (ED) patients. 2. To measure the effects of alternative information prescriptions on medication adherence rates of ED patients. 3. To measure the effects of alternative information prescriptions (IRxs) on health and service utilization.
Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of understanding of the seriousness of the disease, and fear of side effects. An intervention strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be motivational and improve adherence to treatment.
The purpose of this observational research study is to determine when and why patients discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed following stent implantation, and to examine the relationship between specific patterns of non-adherence and patient outcomes.
Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D\&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.
Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D\&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.
Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors. This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.
The overall objective is to examine the influence of various services provided by the community pharmacy on patients' diabetes and diabetes-related health outcomes.
We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.
Can the investigators create an effective way to improve adherence to immunosuppressant medication and reduce rejection, graft loss, and death in adolescents and young adults who have undergone kidney or liver transplantation? The investigators' mobile technology intervention uses real-time electronic pillbox-assessed dose timing and text message prompts to address antirejection medication nonadherence when nonadherence is detected.
The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.