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Clinical Studies
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An Adaptable Platform to Promote Patient Health Through Adherence to
Treatment and Prevention
Rochester, Minn.
The purpose of this study is to create an adaptable platform to support patients with behavior change to improve adherence to treatment and prevention for multiple chronic diseases. The proposed platform will utilize remote monitoring combined with health coaching to create behavior change aimed at improving self-management and quality of life, The proposed system will be cost-effective, scalable, andfeasible for widespread implementation for chronic diseases.
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Pilot Clinical Trial of a home-based program of rehabilitation with health coaching to improve outcomes in post-intensive care syndrome patients
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to develop further and test the feasibility, safety, and efficacy of a home-based, nurse health coach-facilitated program of PR, physical activity and symptom monitoring, and comprehensive remote health coaching intervention that aims to improve health-related quality of life (HRQoL), daily physical activity, Post ICU Syndrome (PICS) domain-specific impairments, caregiver burden, and healthcare utilization in PICS patients from hospitals with distinct location, diversity, and practice settings.
Closed for Enrollment
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A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Rochester, Minn.
To establish the feasibility of a tool that monitors and motivates people with COPD to complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at home.
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A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients (Spire)
Rochester, Minn.
The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.
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A Lifestyle Program for Severe Comorbid Obstructive Sleep Apnea with Severe Obesity (OSA)
Rochester, Minn.
The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.
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A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Rochester, Minn.
The purpose of this study is to get definite evidence for the effectiveness of a short preoperative inspiratory muscle training protocol on the level of sickness and recovery of patients who are having the surgical removal of a portion of the esophagus.
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COPD Hospitalization Registry
Rochester, Minn.
The purpose of this study is to assess and characterize health care utilization along with a survey-based parameter of demographic, functional and physiologic domains. In addition, we hope to see how additional hospitalizations or ER visits impact the trajectory of quality of life after a COPD related health care event. Patients that are eligible and willing to particpate will complete two questionniares at baseline and at 3, 6 and 12 months. The first questionnaire is about health care utilization. The second questionnaire is about breathing and quality of life.
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Effect of Meditation on Emotional Buoyancy and Burnout in Physicians
Rochester, Minn.
This study aims to establish whether brief daily meditation will positively impact physicians’ emotional buoyancy and overall well-being. Secondary outcomes include perceived happiness, physician burnout, and physical activity/sleep quality to be measured by an activity monitor. The latter will be measured to provide a more comprehensive picture of physician well-being. This pilot study also seeks to establish the feasibility of using the Muse™ device to assist novice meditators in building and strengthening their practice.
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Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation
Rochester, Minn.
The purpose of this study is to test an existing home-based pulmonary rehab program with the addition of video chat.
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Feasibility of a Multi Component Intervention in Patients with Severe Dyspnea and Obesity
Rochester, Minn.
The purpose of this study is to define the feasibility and effectiveness of a multi-component intervention aimed at decreasing perception of dyspnea in participants with lung disease who are obese.
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Home Pulmonary Rehabilitation for COPD
Rochester, Minn.,
Jacksonville, Fla.
While pulmonary rehabilitation provides benefits to people with COPD, only 1.5% have access to pulmonary rehabilitation each year. The main barriers are related to travel and transportation. This protocol will evaluate the effect of a home-based rehabilitation system on quality of life and steps. The system allows for monitoring by a health care system. A health coach will review the data and provide coaching to facilitate behavioral change and self-efficacy. Patients will be randomized to 1 of 2 groups.
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Home-based Health Management of COPD Patients
Rochester, Minn.
Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.
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Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis
Rochester, Minn.
The purpose of this study is to assess the effect-size of a novel combined home-based telemonitored pulmonary rehabilitation and telephonic health coaching program on two co-primary endpoints: 1) patient-reported quality of life as assessed by the COPD Assessment Test (CAT) and 2) physical activity (PA) as measured by steps per day.
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Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.
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L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD) (LC4COPD)
Rochester, Minn.
We hypothesize that supplementation with L-carnitine that is available both as an FDA-approved therapy for primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires in patient with chronic obstructive pulmonary disease (COPD). We further hypothesize based on our review of literature that addition of health coaching (HC) to L-carnitine will yield greater gains.
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Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to explore the benefit of Health Coaching on patients with COPD versus self guided lifestyle education. The goals are to see if Health Coaching improves well-being and quality of life and physical activity in patients with COPD and also if the benefits are maintained overtime (lifestyle change). This study will also be looking at how often a patient visits the doctor unscheduled for COPD related causes.
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Mindfulness to Mitigate the Effect of Anxiety-depression-fear in COPD
Rochester, Minn.
People with COPD have a greater risk for symptoms of depression, anxiety, and fear of breathlessness. Those emotions are independently associated with lower physical activity, poorer quality of life, and higher hospitalization and exacerbations; all independent predictors of survival and costs. There is a lack of treatment options to be routinely used in primary clinics for patients with COPD. Systematic reviews suggest that interventions that promote an accepting mode of response, such as mindfulness, might be more appropriate and effective for managing psychological distress in COPD patients, especially breathing-related anxiety. Hypothesis: A home-based 8-week Mindfulness-Based Stress Reduction (MBSR) for COPD targeted to individuals with symptoms of depression, anxiety, or fear of breathlessness delivered by a mindfulness coach using a combination of in-person sessions and remote video call sessions will be effective in improving emotional and overall quality of life, and measured physical activity.
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Multicomponent Intervention to Decrease COPD-related Hospitalizations
Rochester, Minn.
The investigators' proposed study is a randomized controlled trial that will prospectively examine the effect of a multicomponent intervention on the rate of hospitalizations, daily physical activity, self efficacy and health status in patients who have COPD and have been hospitalized because of a COPD exacerbation.
In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation, who meet the selection criteria and agree to participate will be randomized to receive one of the following at the time of hospital discharge: (1) the current standard of care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the current standard of care without the intervention.
This study plans to test the following hypotheses: (1) The primary outcome of the study to be the composite endpoint of death or COPD hospitalization (2) Time to first rehospitalization will be shorter in the intervention group than the control group (3) At follow-up, the physical activity level measured in terms of the average number of steps and active energy expenditure will be higher in the intervention group than in the control group.
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Pulmonary Rehabilitation Before Lung Cancer Resection
Rochester, Minn.,
Jacksonville, Fla.
This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).
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Remote Monitoring with Health-Coaching for Lifestyle Changes in Patients with Lung Cancer Related Fatigue
Rochester, Minn.
The purpose of this study is to test the effectiveness of a remote monitoring program with health coaching for patients with cancer related fatigue.
The primary objective is to assess the effect of the remote-monitoring program on patient reported fatigue by administering the Brief Fatigue Inventory and the Cancer Fatigue Scale/ MFSI-SF. Secondary objective is to assess the effect of the program on quality of life by administering the LASA questionnaire.
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