SYMPTOM MANAGEMENT FOR CHRONIC NEUROLOGICAL CONDITIONS Release Date: February 23, 1998 PA NUMBER: PA-98-030 P.T. National Institute of Nursing Research National Institute on Aging National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Nursing Research (NINR), National Institute on Aging (NIA), National Institute of Child Health and Human Development (NICHD), National Institute on Deafness and Other Communication Disorders (NIDCD), and National Institute of Neurological Disorders and Stroke (NINDS) are interested in facilitating investigator-initiated research designed to deal with symptoms associated with chronic neurological conditions including stroke, epilepsy, brain and spinal cord injury, multiple sclerosis, and Parkinson's disease. The overall goals are to manage symptoms effectively, to prevent secondary effects of the condition when possible, to maximize the health potential, and to improve the health-related quality of life for patients, caregivers, and families. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Symptom Management for Chronic Neurological Conditions, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Research applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. RESEARCH OBJECTIVES Background Chronic neurological conditions, including stroke, epilepsy, brain and spinal cord injury, multiple sclerosis, and Parkinson's disease are particularly disabling illnesses experienced by a significant proportion of the United States population. Individuals living with a chronic neurological condition may experience a wide variety of symptoms that require health care services and significantly interfere with health-related quality of life and functional abilities. Health care providers need effective strategies to assist individuals with these chronic illnesses and their consequences. Research is needed to determine factors that contribute to these conditions and on methods to deter, ameliorate, or prevent, where possible, the symptoms or their sequelae. Since these conditions affect individuals across the life span and in a variety of settings including homes, acute care, ambulatory care, and home health care, research is needed that addresses the specific context and associated factors that may be important including other factors such as age, gender, and minority status. In addition, family caregiving issues need to be considered in some studies in order to find effective symptom management strategies to assist both the patient and the family caregiver. The overall goals of the symptom management strategies are to prevent the onset of further disabilities, encourage independence, and enhance health- related quality of life. Patients who have had a stroke may experience a wide range of symptoms including varying degrees of paralysis, weakness, spasticity, contractures, communication (speech, voice and language) problems, swallowing problems, sensory deficits, pain, visual losses, memory and reasoning deficits, depression, and coma. These symptoms may improve to some degree, but many individuals never fully recover and need assistance throughout their remaining life. To date, scientific progress has been made in understanding and preventing stroke and improving the emergency care of stroke patients. However, scientific evidence for dealing with the post- stroke condition is extremely limited (AHCPR, 1995). Advances in the treatment of epilepsy include implantable devices, new antieplileptic drugs, and advances in surgery, imaging techniques, and genetics research. Despite these improvements, however, many patients with epilepsy experience significant consequences of the seizure disorder, including physical injuries, inadvertent responses to medications, psychological sequelae, learning problems, and social difficulties including withdrawal and isolation. Adherence to treatment regimens is a critical issue that warrants additional research attention in this population. Psychoeducational and behavioral interventions designed to promote effective self-management and minimize or prevent the consequences of epilepsy are important areas of needed investigation. Brain and spinal cord injuries present management challenges in all phases including limiting the immediate damage, handling the consequences of loss of function, and encouraging functional recovery. Research is needed to develop improved methods of dealing with problems such as paralysis, spasticity, cognitive and memory deficits, aggressive behavior and agitation, pain, pressure ulcers, pulmonary difficulties, bone deterioration, muscle wasting, problems with bowel and bladder function, and psychosocial aspects. Investigations are also needed on issues of nutrition, physical conditioning, and sleep in these individuals. The chronic, degenerative and sometimes intermittent nature of multiple sclerosis is associated with neurological consequences such as numbness or tingling, vision loss, weakness, paralysis, unsteady gait, vision difficulties, fatigue, heat intolerance, and evolving communication difficulties. Effective management issues need to be tested for these symptoms in order to promote physical, mental, and social health and well being. Individuals who have Parkinson's disease experience rigidity, resting tremor, bradykinesia, and loss of postural reflexes. Secondary symptoms may include depression; emotional changes; memory and sleep problems; changes in speech, voice, and language production; urinary or bowel difficulties; low blood pressure upon standing or problems in chewing or swallowing. The symptoms may vary widely across individuals and with time. Objectives Research applications may address issues related to managing the symptoms of selected chronic neurological conditions, including stroke, epilepsy, brain and spinal cord injury, multiple sclerosis, and Parkinson's disease. Research objectives could include, but are not limited to: o Factors contributing to the improved physical and psychological status of individuals with chronic neurological conditions, o Interventions to improve or maintain functioning, including physiological, behavioral, cultural, and psychosocial aspects, o Methods to delay the progression of the condition or to prevent further disability, o Strategies to deal with issues such as diet, fatigue, mobility, pain, physical conditioning, sleep, stress, and depression, o Factors associated with family caregiving issues and adaptation strategies as they relate to the health and quality of life of both the patient and caregiver. Projects may be descriptive or experimental. With adequate justification of knowledge gaps, data may be collected that will enhance the development of clinical interventions. However, where possible, interventions which are designed to reduce the severity, frequency, duration or distress of symptoms should be evaluated for efficacy under conditions that will permit comprehensive analysis of appropriate outcome measures. It is imperative that proposed interventions not compromise the effectiveness of the treatment regimen. Interventions should also have the potential for implementation into routine clinical practice. Because of the complex interaction of clinical symptoms and the associated subjective response, a multidisciplinary research approach is recommended. Expertise from health-related disciplines should be included as appropriate for both the target symptom and the clinical population. Applicants are encouraged to make use of ongoing clinical trials or other medical research efforts where feasible. Applications from institutions that participate in ongoing clinical trials or have a General Clinical Research Center (GCRC) may wish to identify these programs as a resource for conducting the proposed research. If so, a letter of agreement from the program director or the Principal Investigator should be included with the application. Related Program Announcements that may be of interest include: PA-97-050: Managing the Symptoms of Cognitive Impairment PA-97-048: Self-Care Behaviors and Aging PA-97-024: Spinal Cord Injury: Emerging Concepts PA-96-032: Communicative Competence of Users of Augmentative and Alternative Communication (AAC) Systems PA-95-056: Biobehavioral Pain Research PA-95-014: Basic and Clinical Research on Sleep and Wakefulness PA-95-034: Evaluation, Treatment and Prognosis of the Communication Sequelae of Traumatic Brain Injury The full text of these program announcements may be accessed through the NIH Guide for Grants and Contracts at http://www.nih.gov/grants/guide/index.html INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The complete original application and five legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique. Applications will also undergo a process in which only those deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score: (1) Significance Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research will be reviewed. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that institute or center. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. We welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Mary D. Leveck, Ph.D., R.N. Scientific Program Administrator National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: mary_leveck@nih.gov Louis A. Quatrano, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2AO3 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: LQ2N@nih.gov Stephen Tuel, M.S.E., M.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A03, MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: tuels@box-t.nih.gov Dr. Beth Ansel Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC 7180 Bethesda, MD 20892-1780 Telephone: (301) 402-3461 FAX: (301) 402-6251 Email: Beth_Ansel@NIH.GOV Judith A. Finkelstein, Ph.D. Sensory/Motor Disorders of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307, MSC 9205 Bethesda MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: jf119k@NIH.GOV Mary Ellen Cheung, Ph.D. Division of Stroke, Trauma and Neurodegenerative Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892-9155 Telephone: (301) 496-4226 FAX: (301) 480-1080 Email: MM108W@nih.gov Direct inquiries regarding fiscal matters to: Jeff Carow Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-12, MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: jcarow@ep.ninr.nih.gov Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development Building 61E, Room 8A17 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: MC113B@nih.gov Sharon Hunt Grants Management Officer National Institute of Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400B, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 Email: Sharon_Hunt@NIH.GOV Joseph Ellis Grants Management Officer National Institute on Aging Gateway Building, Suite 2N212, MSC 9205 Bethesda MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: ellisj@exmur.nia.nih.gov Gladys Melendez-Bohler Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 10-04 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: GB13Y@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.361 and 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Agency for Health Care Policy and Research. (1995). Post-Stroke rehabilitation: Assessment, referral, and patient management. Clinical Practice Guideline. Rockville, MD: DHHS, PHS, AHCPR, Pub. No. 95-0662. National Conference on Public Health and Epilepsy, Living Well with Epilepsy, Centers for Disease Control and Prevention, Orlando, Florida, September 10-11, 1997. National Institute of Child Health and Human Development (1993). Research Plan for the National Center for Medical Rehabilitation Research. Bethesda, MD: DHHS, PHS, NIH, NICHD, Pub. No. 93-3509.
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