Nervous System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Rare Diseases

Cerebral Palsy

Paralysis

Heart Diseases

Lung Diseases

Metabolic Diseases

Heart Defects, Congenital

Metabolism, Inborn Errors

Brain Injuries

Brain Damage, Chronic

Brain Diseases

Central Nervous System Diseases

Respiratory Tract Diseases

Congenital Abnormalities

Cardiovascular Abnormalities

Genetic Diseases, Inborn

Chronic Graft Versus Host Disease

Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care

Mobile-health communication tool for parents of children with medical complexity

GoalKeeper

Standard Care

Lee M Sanders, MD, MPH

This proposal addresses the major challenge of improving health outcomes for children with cancer and other complex conditions, for whom the effectiveness of outpatient care depends on care coordination across a diverse group of caregivers that includes parents, community support organizations and pediatric care providers. The investigators have developed GoalKeeper, a prototype system for supporting care coordination across multiple care providers. The primary aim of the clinical trial is to assess the potential for this new system, GoalKeeper, to improve meaningful use of goal-centered care plans in the care of children with cancer and other complex chronic conditions.

The overarching aim of the research is to improve care coordination and goal setting for children with medical complexity (CMC). Specific aims of the pilot clinical trail are as follows: (1) To assess the efficacy of GoalKeeper on goal-setting in the health care encounter. (2) To examine the roles of parent health literacy and parent activation in moderating the effect of the intervention.

Study Population: Stanford's Primary and Subspecialty Care Clinics at Stanford Children's Health will serve as the setting for study recruitment.

The pilot randomized controlled trial will enroll 60 parents of children with medical complexity and their health-care providers. Eligibility criteria for participants will be age 18 years or older, English-speaking, and (for parents) child\<12 years old. Exclusion criteria are parent with known mental illness or neurocognitive impairment. A stepped wedge approach by provider will introduce families to GoalKeeper at different time points in the study. A pre-intervention period will occur at least 1 month before the trial start where clinical observations and baseline survey information will be obtained of each providers' practice.

Each family will be given training and 4-month access to the GoalKeeper application and participate in an exit interview at the end of study.

GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity

Intelligent Information Sharing: Advancing Teamwork in Complex Care

Parent perception will be measured using the "National Survey of Children with Special Health Care Needs Shared Decision Making Domain," which includes 4 domain items each with a scale of 1 (never), 2 (sometimes), 3 (usually) or 4 (always). Positive SDM is defined as parent report of "usually" or "always" on all 4 items. Shared decision making refers to a communication process where parents and providers participate in decision making to reach treatment plan agreement.

Parent perception of goal-centered care will be measured using a modified version of the "Patient Assessment of Chronic Illness Care, Goal-Setting Domain" questionnaire, using a scale of 1(Almost Never) to 5 (Almost Always) with higher values representing better goal-centered care.

Change in perception in quality of goal-centered care will be assessed by Investigators based on parent baseline interviews and parent exit interviews.

National Cancer Institute (NCI)

Harvard University

Stanford University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Death

Body Weight

Premature Birth

Necrosis

Birth Weight

Craniocerebral Trauma

Trauma, Nervous System

Anti-Inflammatory Agents

All Drugs and Chemicals

Antineoplastic Agents

Analgesics

Interleukin-2

William Oh, MD

Michele C. Walsh, MD MS

Ronald N. Goldberg, MD

Barbara J. Stoll, MD

James A. Lemons, MD

Abhik Das, PhD

David K. Stevenson, MD

Waldemar A. Carlo, MD

Neil N. Finer, MD

Edward F. Donovan, MD

Shahnaz Duara, MD

Lu-Ann Papile, MD

Sheldon B. Korones, MD

Jon E. Tyson, MD MPH

Abbot R. Laptook, MD

T. Michael O'Shea, MD MPH

Seetha Shankaran, MD

Richard A. Ehrenkranz, MD

This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at 18-22 months corrected age.

Inflammatory cytokines \[interleukin-1 (IL-1β), IL-8, IL-9, tumor necrosis factor-α (TNF-α), and RANTES\] but not anti-inflammatory cytokines released during the perinatal period have been associated with the development of periventricular leukomalacia (PVL) and cerebral palsy (CP) in near term and term infants. However, because blood samples were obtained on any day between day 1 and 18, these data cannot distinguish between prenatal and postnatal effects on neurological outcome. Furthermore, very low birth weight infants who are at the highest risk have not been studies.

The goal of this study was to measure pro-inflammatory and anti-inflammatory cytokine levels at various times in the perinatal period (at birth up to day of life 21), since they may be elevated at different points in the disease process. Blood samples (whole blood spots, dried on filter paper) were obtained on day 1 within 4 hours after birth, and on days 3, 7, 14, and 21. Neurodevelopmental assessments were conducted at 18-22 months corrected age.

Whole blood spots collected on filter paper.

Inflammatory Cytokines Associated With Perinatal Brain Injury

A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death

Centers for Disease Control and Prevention

National Center for Research Resources (NCRR)

NICHD Neonatal Research Network

Waldemar A. Carlo, MD, Lead Principal Investigator

Musculoskeletal Diseases

Neoplasms

Skin and Connective Tissue Diseases

Osteoarthritis

Rupture

Scoliosis

Osteosarcoma

Lacerations

Spinal Curvatures

Spinal Diseases

Bone Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Acute Graft Versus Host Disease

Soft Tissue Sarcoma

MaryBeth Horodyski, EdD

Parker Gibbs, MD

Data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and neuromuscular disorders will be collected and stored as part of the normal clinical care of patients seen in the University of Florida (UF) and Shands Orthopaedics and Sports Medicine Institute.

All patients seen the Orthopaedic clinic will be informed of the data collection and asked to participate. If the patient is agreeable to participation, informed consent will then be obtained.

Clinical Orthopaedic Data Bank (Acute and Chronic)

Orthopaedic Data Bank; Collection and Storage of Data Relating to Orthopaedic Disorders

Medical Record information will be used as needed for a future IRB retrospective study

University of Florida

Immune System Diseases

Infections

Parkinson Disease

Stroke

Spinal Cord Injuries

Sclerosis

Multiple Sclerosis

Hemiplegia

Ataxia

Cerebellar Ataxia

Myelitis

Myelitis, Transverse

Friedreich Ataxia

Muscle Weakness

Paresis

Brain Injuries, Traumatic

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Movement Disorders

Synucleinopathies

Neurodegenerative Diseases

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Spinal Cord Diseases

Neurologic Manifestations

Spinocerebellar Ataxias

Spinocerebellar Degenerations

Cerebellar Diseases

Heredodegenerative Disorders, Nervous System

Mitochondrial Diseases

Communicable Diseases

Central Nervous System Infections

Neuroinflammatory Diseases

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Transverse Myelitis

Spinocerebellar Ataxia

Participants will engage in a live zoom exercise session. Participants will undergo 45 minutes of aerobic exercise intervention, three times a week, for a period of 12 weeks. Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.

Participants will undergo 45 minutes of aerobic exercise intervention, three times a week, for a period of 12 weeks, using a pre-recorded class that they can do according to their own schedule. Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.

Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.

Seated exercise

Kathleen Friel

To assess the impact of a 12-week virtual seated physical intervention on cardiovascular health and wellness in people with chronic neurological impairments (CNI).

This study aims to examine how effective seated Zoom exercise classes are for a person with CNI for addressing cardiovascular health, physical wellness and quality of life. If these classes prove to be effective, online platforms could be a viable avenue for those with CNI to exercise and increase/maintain wellness without having to leave their homes. The investigators are also attempting to determine if a class with a live instructor vs a pre-recorded class has an effect on motivation, compliance, exertion and modifications/safety.

The entire process, including screening and consenting, will be done via Zoom and Redcap, potentially providing a blueprint for the future studies. This process can enable participants to participate in studies with minimal inconvenience, expense and effort of traveling for the consent process.

One group will attend live zoom classes with instructor feedback, and the other group will exercise using pre-recorded sessions.

Home Based Tele-exercise for People With Chronic Neurological Impairments

We plan to use the concept, methods and analysis as a framework to develop evidence-based protocols for future cohorts and studies. We have made a commitment to publish all relevant scientific information in a timely manner. Unpublished information may be available to interested individuals or organizations by request to the Principal Investigator.

Heart rate on last day of training compared to heart rate on first day of training

a 36-item instrument used to measure an individual's perceived health status in physical, psychological, emotional, intellectual, spiritual, and social wellness constructs

a self-assessment measure of enjoyment with their current physical activity

measures physical health and mental health

standardized instrument for pain assessment in clinical and research practice. It is an 11-point scale from 0 (no pain) to 10 (the most intense pain) at rest and during movement

standardized measure to evaluate perceived intensity of exertion, effort, and fatigue during physical exercise

is a 24-item scale to assess the reason that motivates a person to exercise

Burke Medical Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity	NCT03620071	Childhood Cance... Cerebral Palsy Chronic Lung Di... Congenital Hear... Congenital Meta... Gastrostomy	GoalKeeper Standard Care	18 Years -	Stanford University
Inflammatory Cytokines Associated With Perinatal Brain Injury	NCT01035697	Infant, Newborn Infant, Low Bir... Infant, Small f... Infant, Prematu... Cerebral Palsy		- 72 Hours	NICHD Neonatal Research Network
Clinical Orthopaedic Data Bank (Acute and Chronic)	NCT00411060	Osteoarthritis Osteosarcoma Scoliosis Cerebral Palsy		-	University of Florida
Inflammatory Cytokines Associated With Perinatal Brain Injury	NCT01035697	Infant, Newborn Infant, Low Bir... Infant, Small f... Infant, Prematu... Cerebral Palsy		- 72 Hours	NICHD Neonatal Research Network
Home Based Tele-exercise for People With Chronic Neurological Impairments	NCT04564495	Neurologic Diso... Stroke Spinal Cord Inj... Cerebral Palsy Hemiplegia Hemiparesis Multiple Sclero... Parkinson Disea... Trauma, Brain Transverse Myel... Friedreich Atax...	Seated exercise	18 Years - 75 Years	Burke Medical Research Institute
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity	NCT03620071	Childhood Cance... Cerebral Palsy Chronic Lung Di... Congenital Hear... Congenital Meta... Gastrostomy	GoalKeeper Standard Care	18 Years -	Stanford University
Home Based Tele-exercise for People With Chronic Neurological Impairments	NCT04564495	Neurologic Diso... Stroke Spinal Cord Inj... Cerebral Palsy Hemiplegia Hemiparesis Multiple Sclero... Parkinson Disea... Trauma, Brain Transverse Myel... Friedreich Atax...	Seated exercise	18 Years - 75 Years	Burke Medical Research Institute

Spots Global Cancer Trial Database for cerebral palsy