[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"health-care-delivery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:health-care-delivery":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,56,96,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100619127","implementation-facilitation-of-exercise-is-medicine-greenville-100619127",false,"NCT07340580","Implementation Facilitation of Exercise is Medicine Greenville","Facilitating Health System Implementation of Physical Activity Screening and Referral to Community-Based Programs: Exercise is Medicine Greenville","The primary aim of this study is implementation facilitation at the clinic level. The secondary aim of this study is at the patient level. Therefore we have divided our inclusion\u002Fexclusion eligibility criteria by primary and secondary aim.\n\n1\\. Clinic (primary aim) Inclusion criteria\n\n* Currently EIMG-activated Prisma Health-Upstate Primary Care clinic (family or internal medicine)\n* Adopted EIMG \\>= 6 months prior to the beginning of this study\n\nExclusion criteria\n\n* Not EIMG-activated\n* Adopted EIMG \\\u003C 6 months prior to the beginning of this study\n* Greater than 15 miles from the nearest YMCA\n\n  1\\. Primary care clinic staff (primary aim) Inclusion criteria\n* At least 18 years of age\n* Has worked at the Prisma Health-Upstate clinic since the start date of the intervention in the respective wave, i.e., Pre-IF start date for each wave\n* Has clinical encounters with a minimum of 25 patients per month\n* Study clinic is their primary clinic (\\>50% of their working time)\n* Able to understand and communicate in English\n\nExclusion criteria\n\n* Less than 18 years of age\n* Work at the Prisma Health-Upstate clinic started after the Pre-IF phase began\n* Has clinical encounters with \\\u003C25 patients per month\n* Unable to speak or understand English\n* Adults unable to provide consent\n\n  2\\. Patient (secondary aim) Inclusion criteria (must meet all of below)\n* Age \\>= 18 and \\\u003C= 80 years\n* Clinically eligible (diagnosis of hypertension, dyslipidemia, obesity, diabetes, or physical inactivity) to receive an EIMG referral\n* A healthcare visit with an eligible encounter type (evaluation, telemedicine, consult, office visit, e-visit, follow-up, appointment, education, multidisciplinary visit, nutrition, occupational medicine-office visit)\n* A healthcare visit at a participating clinic\n\nExclusion criteria\n\n* Age \\\u003C 18 or \\> 80 years\n* Current referral to Physical therapy or occupational therapy\n* Current referral to cardiac, pulmonary, or oncology rehab\n* One of the following visit diagnoses listed below:\n\n  * Alzheimer's disease\n  * Amyotrophic lateral sclerosis\n  * angina or chest pain\n  * congenital stenosis of aortic valve\n  * congenital insufficiency of aortic valve\n  * moderate or severe persistent asthma\n  * typical or atypical atrial flutter\n  * autonomic dysreflexia\n  * acute bronchitis\n  * cerebral infarction\n  * encounter for chemotherapy\n  * chronic kidney disease (stage 3-5)\n  * end stage renal disease\n  * coma\n  * acute chronic obstructive pulmonary disease\n  * unspecified dementia\n  * dependence on renal dialysis\n  * trisomy 21\n  * pulmonary embolism\n  * venous embolism and thrombosis\n  * history of falling\n  * acute fracture\n  * left ventricular failure\n  * congestive heart failure\n  * hypertensive urgency, emergency or crisis\n  * diabetes with ketoacidosis\n  * chronic respiratory failure\n  * dependence on supplemental oxygen\n  * myocardial infarction\n  * osteoporosis with current fracture\n  * encounter for palliative care\n  * paraplegia or quadriplegia\n  * Parkinson disease\n  * pneumonia\n  * encounter for supervision of pregnancy\n  * encounter for radiation therapy\n  * serious mental illness (schizophrenia, psychotic disorder)\n  * homicidal or suicidal ideations\n  * sepsis\n  * injury of spinal cord\n  * presence of coronary stent\n  * dependence on wheelchair or ambulatory aid\n\nFor patients completing accelerometry data collection, the additional inclusion\u002Fexclusion criteria apply:\n\nInclusion criteria:\n\n* Received an EIMG referral and scheduled for orientation\n* Attending orientation at two pre-determined community PA facilities (these sites were selected due to each being the largest urban and rural YMCA referral sites in the study)\n\nExclusion criteria:\n\n* Unable to provide verbal informed consent\n* Planning on travel or vacation during data collection, as patient PA behavior is anticipated to differ from 'everyday' PA behavior at home\n* Unable to wear a watch during work hours due to employment restrictions e.g., food service, healthcare, operating heavy machinery\u002Fconstruction, laboratory-based work etc.\n\nIn addition, for patients completing interviews, the additional inclusion\u002Fexclusion criteria apply:\n\nInclusion criteria:\n\n\\- Received an EIMG referral\n\nExclusion criteria:\n\n* Unable to provide verbal informed consent\n* Unable to speak or understand English\n* \\\u003C18 years of age",true,"ALL",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"NA","A public health priority exists for the U.S. healthcare sector to integrate physical activity (PA) as a part of the patient care model. This research will provide valuable information on facilitating optimal implementation of a clinic-to-community model that identifies, refers, and enrolls physically inactive patients to community-based PA programs for the prevention and treatment of chronic diseases. Further, this work will provide evidence on the cost-effectiveness of integrating PA in healthcare systems as a population health management strategy.",[26,27,28,29,30,31,32,33,34,35,36],"Physical Inactivity","Dyslipidemia","Obesity and Overweight","Hypertension","Diabetes","Health Care Delivery","Patients","Chronic Disease","Exercise","Physical Activity","Implementation Science",[38,39,40,41,42],"Implementation Facilitation","Physical activity referral scheme","Effectiveness-implementation hybrid type 3","Pragmatic design","Stepped wedge","NOT_YET_RECRUITING","2026-03-27",{"date":46,"type":47},"2026-04-02","ACTUAL",{"date":49,"type":20},"2026-05-01",{"date":51,"type":20},"2030-07-31",{"name":53,"class":54},"University of South Carolina","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":68,"conditions":69,"keywords":76,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100561160","the-family-icu-trial-100561160","NCT06586541","The Family-ICU Trial","Family Participation in Intensive Care Unit Rounds (The Family-ICU Trial)","Family-ICU","Inclusion Criteria:\n\n* Adult family members (age ≥ 18 years) of ICU patients\n* Expected ICU stay ≥ 48 hours\n* Family members wishing to participate in rounds virtually must have the technological capability and understanding to participate virtually (must have a phone or computer with internet and audio\u002Fvideo capabilities)\n\nExclusion Criteria:\n\n* Family members who do not wish to participate in care\n* Repeat admissions within the study period\n* Another family member has already participated in the study","18 Years",{"count":66,"type":20},194,[23],"Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.",[70,71,72,31,73,74,75],"Virtual Care","Family Engagement","Patient and Family Engagement","Family-centered Care","Physician Rounds","Critical Care, Intensive Care",[77,78,71,79,80,81,82,83,84,74],"Patient- and Family-Centered","Patient- and Family-Centered Care","Critical Care","Intensive Care Unit","Person-Centered Care","Delivery of Health Care","Virtual Rounds","Family Participation in Rounds","RECRUITING","2026-03-25",{"date":88,"type":47},"2026-03-31",{"date":90,"type":47},"2024-11-18",{"date":92,"type":20},"2029-07",{"name":94,"class":54},"Lady Davis Institute",2,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":16,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":95},"100591772","the-family-cares-trial-100591772","NCT06984770","The Family Cares Trial","Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)","Family Cares","Inclusion Criteria:\n\n* (1) Family member of a person admitted to an ICU for \\>48 hours and survived to hospital discharge. \"Family\" is anyone with a biological, legal, or emotional relationship with the patient and whom the patient wants involved in their care\n* (2) Planned or current part or full-time caregiver of the ICU survivor\n* (3) Age ≥ 18 years\n* (4) Within 6 months of ICU survivor's hospital discharge.\n\nExclusion Criteria:\n\n* (1) Another family member participating in the study\n* (2) Inability to communicate in English or French.",{"count":105,"type":20},60,[23],"The goal of this pilot study is to learn if virtual peer support groups and strengths-based skills training can help family caregivers of ICU survivors providing ongoing support to ICU survivors after hospital discharge. The main question it aims to answer is:\n\n\\- Are virtual peer support groups and\u002For strengths-based skills support feasible and acceptable for family caregivers of ICU survivors? Researchers will compare the intervention group (virtual peer support groups or strengths-based skills training) to the control group (no intervention) to see if the interventions improve caregiver outcomes and assess feasibility and acceptability.\n\nParticipants will:\n\n* Participate in either virtual peer support groups or strengths-based skills training sessions (if assigned to the intervention arm).\n* Provide feedback on the feasibility and acceptability of the interventions (if assigned to the intervention arm).\n* Complete surveys and follow-up questionnaires (either online or by phone) to measure outcomes.",[71,75,72,31,73,109,110,111,112],"Pilot Study","Caregiver","Caregiver Burden","Family Caregivers",[78,71,79,80,81,82,114,115,116],"Post-ICU","Caregivers","Family Caregiver","2025-05-14",{"date":119,"type":47},"2025-05-22",{"date":121,"type":20},"2025-08",{"date":123,"type":20},"2027-08",{"name":94,"class":54},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":95},"100561159","increasing-family-engagement-in-critical-care-100561159","NCT06586528","Increasing Family Engagement in Critical Care","Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE Trial)","NGAGE","Inclusion Criteria:\n\n* Adult family members (age ≥ 18 years) of ICU patients\n* Expected ICU stay ≥ 48 hours\n* Able to participate in English or French\n\nExclusion Criteria:\n\n* Family members who do not wish to participate in care\n* Repeat admissions within the study period\n* Another family member has already participated in the study",{"count":66,"type":20},[23],"The primary aim of this trial is to evaluate if the NGAGE tool improves care engagement in family members of ICU patients. The secondary objectives are to assess if the NGAGE tool improves communication, care satisfaction, psychological symptoms, and quality of life in family members of ICU patients.\n\nThe NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs, involving 194 family members. A family member will be considered anyone with a biological, emotional, or legal relationship with the patient and whom the patient wishes to be involved in their care. There will be random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The intervention group will have access to the NGAGE tool, which has modules to Learn, Engage, and Report. \"Engage\" allows the family member to indicate their desired engagement activity, which is then transmitted to the treating healthcare team to provide the requested activity. \"Learn\" contains educational capsules about the ICU environment and information about care participation. \"Report\" allows the family member to provide real-time feedback to the healthcare team. The primary endpoint is the FAMily Engagement (FAME) score within 1 week of ICU discharge. Secondary endpoints are family-centered outcomes, including communication quality, satisfaction, and mental health (anxiety and depression) scores within 1 week of ICU discharge, and quality of life and mental health (anxiety, depression, and post-traumatic distress symptoms) at 6 months. The mean difference of the validated FAME score, a continuous variable, will be compared between groups.",[71,75,72,31,73],[78,71,79,80,81,82],{"date":139,"type":47},"2025-05-18",{"date":141,"type":47},"2025-03-26",{"date":143,"type":20},"2027-09",{"name":94,"class":54}]