Clinical Research Directory

OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)

Hypertension (HTN) has a greater impact on African Americans (AA) than any other U.S. racial group. Uncontrolled blood pressure (BP) contributes to higher rates of disability, death, and health resource use among AA. HTN is the single most influential risk factor for cardiovascular disease (CVD), as well as a risk factor for the incidence of stroke, diabetes, chronic kidney disease, and dementia. Importantly, older adults account for 15% of the U.S. population, and two-thirds of older adults over age 60 have HTN, with higher rates observed in AA older adults. Strategies to support self-managing HTN and BP control are crucial as the older population is projected to age considerably and become more racially and ethnically diverse. Research has documented the negative effects on health and health outcomes of poorly controlled BP and is one of the most important modifiable CVD risk factors. Lower BP targets will require aggressive management and an increase in antihypertensive medications. Therefore, to achieve lower targets in this population, greater efforts, including patient-centered methods will be needed to support self-managing HTN, especially in terms of medication adherence. As we shifted into the digital age, the use of mHealth technologies (smart phones, applications, SMS or text messaging) has been a powerful approach and mechanism for the treatment and management of chronic diseases. However, behavioral interventions that incorporate technology do not reach minorities or disadvantaged AA older adults with HTN. OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP) will leverage existing knowledge of effective technology-based components for HTN self-management to support and improve BP control using unique aspects of mHealth platforms in AA older adults. Findings from this study, if confirmed, will improve BP control and support self-managing HTN, as well as has the potential to close the health disparity gap between AA and non-AA older adults with HTN.

Efficacy of a Self-advocacy Serious Game Intervention

Individuals with cancer must overcome multiple, ongoing challenges ("self-advocate") related to their cancer experience to receive patient-centered care. Women with metastatic cancer often face significant challenges managing their quality of life concerns and cancer- and treatment-related symptoms. If they do not self-advocate to manage these concerns, they risk having poor quality of life, high symptom burden, and care that is not patient-centered. Serious games (video games that teach) are effective health interventions that allow users to vicariously engage in situations reflecting their personal experiences, receive meaningful information, and learn personally relevant skills that they can apply in real life. The goal of the current study is to test the efficacy of a novel intervention using a serious game platform to teach self-advocacy skills to women with advanced cancer. The Strong Together intervention consists of a multi-session, interactive serious game application with tailored self-advocacy goal-setting and training. The serious game is based on a self-advocacy conceptual framework and applies behavior change theories and serious game mechanisms to promote skill development and implementation. The game works by immersing users in the experiences of characters who are women with advanced cancer; requiring users to make decisions about how the characters self-advocate; demonstrating the positive and negative consequences of self-advocating or not, respectively; and providing multiple, individualized feedback mechanisms and game features to enforce self-advocacy skill acquisition and transference to real life.

Development and Feasibility of a Nurse-led Person-centered Education Program

Background Psoriasis is a chronic inflammatory skin disease causing reduced quality of life. Psoriasis patients are often insufficiently informed about their disease with its treatment possibilities leading to non-adherence of treatment resulting in unsatisfactory patient outcomes. We therefore propose to develop an educational intervention for psoriasis patients; evaluate the feasibility of implementing it in a nurse-led psoriasis-outpatient clinic and compare the psoriasis percentage reduction, quality of life, health literacy and patient benefit, between patients receiving this educational intervention and those receiving standard care. Method/Design We first will develop an evidence-based educational intervention in collaboration with an expert panel and second will conduct a quasi experimental feasibility study in a psoriasis outpatient clinic in Western Switzerland. Twenty four eligible patients with psoriasis will receive a multidisciplinary education, for 6 weeks. Data will be analyzed using R conducting linear models allowing us to assess the impact of the intervention on psoriasis reduction and other secondary outcomes of interest, once controlled for reliable socio-economic cofounding factors. Discussion This trial will investigate the feasibility of the elaborated nurse-led education and the planed randomized controlled trial. In this study, we will elaborate and provide an informational brochure with information concerning psoriasis in addition to a nurse-led oral educational program in addition to medical standard care. We expect that this nurse-led person-centered intervention will contribute to enhanced education with a higher functioning, better self-efficacy and improved quality of life, better disease knowledge with a better adherence to the medication protocol. The results will further inform the final design of a subsequent large-scale randomized controlled trial, which will examine the effectiveness of this educational intervention. Additionally, through this study the role of the nursing profession and its research will be strengthened in assuring that the voice of individuals, families and communities are incorporated into design and operations of clinical health systems by eliminating gaps and disparities in health care.

Electronic Patient Decision Support System for Patients with Type 2 Diabetes (DiaPaDeSS)

This study evaluates the effects of an electronic patient decision support system developed for the use of patients with type 2 diabetes (DiaPaDeSS) on self-management, patient activation, and metabolic parameters. To manage type 2 diabetes after discharge, patients must continue to perform interventions at home, such as blood glucose monitoring, blood pressure measurement, weight measurement, medication use, and foot care. To achieve this, patient's self-management and activation levels should be increased. This can also lead to positive improvements in the metabolic parameters. It would be beneficial to develop DiaPaDeSS that can increase the self-management and activation levels of patients with type 2 diabetes. The investigators will develop the DiaPaDeSS intervention protocol. Our content includes patient education information about type 2 diabetes, self-management practice tasks (daily, weekly, quarterly), a type 2 diabetes patient education program according to DiaPaDeSS algorithms, and measurement questionnaires. The content of the DiaPaDeSS will be evaluated by 10 experts in the fields of medicine, nursing, and informatics. A feasibility test with seven patients will be conducted to evaluate the usability of DiaPaDeSS. A single-blind, randomized controlled trial design will be used. Patients with type 2 diabetes will be pretested and randomized (intervention 36, control 36) to the DiaPaDeSS intervention and control groups. Both the DiaPaDeSS intervention and control groups will use the DiaPaDeSS for three months. While participants in the DiaPaDeSS intervention group can reach all contents of the DiaPaDeSS, others can reach only these fields: self-management practice tasks (daily, weekly, quarterly), and measurements questionnaires. The effectiveness of the DiaPaDeSS will be evaluated at baseline and at month 3.

Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance

This study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention，number of breakages, and on-time and return visit status.

Effects of a Health Intervention on Fear of Hypoglycemia

To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.