CLINICAL INTERVENTIONS FOR MANAGING THE SYMPTOMS OF STROKE

Release Date:  April 20, 1999

PA NUMBER:  PA-99-088

P.T.

National Institute of Nursing Research
National Institute of Neurological Disorders and Stroke
National Institute on Aging
National Institute on Deafness and Other Communication Disorders
National Institute of Child Health and Human Development

THIS PA USED THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES
DETAILED MODIFICATIONS TO THE STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The National Institute of Nursing Research (NINR), National Institute of
Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA),
National Institute on Deafness and Other Communication Disorders (NIDCD), and the
National Center for Medical Rehabilitation Research (NCMRR) of the National
Institute of Child Health and Human Development (NICHD) seek research
applications that address effective nonpharmacological approaches to managing the
initial events and subsequent symptoms of a stroke.  This research would focus
on reducing the impairments, preventing secondary complications, and improving
the functional independence and the quality of life for the individual following
a stroke.

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 PA, Clinical Interventions for
Managing the Symptoms of Stroke, is related to the priority areas of chronic
disabling diseases and people with disabilities.  Potential applicants may obtain
a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

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

This PA will use the National Institutes of Health (NIH) research project grant
(R01) award mechanism.  Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant. The total project
period for an application submitted in response to this PA may not exceed five
years.

Specific application instructions have been modified to reflect the "MODULAR
GRANT APPLICATION AND AWARD" process, which has been adopted by the NIH (see the
NIH Guide, December 15, 1998).

For this PA, funds must be requested in $25,000 direct cost modules.  A feature
of the modular grant is that no escalation is provided for future years, and all
anticipated expenses for all years of the project must be included within the
number of modules being requested.  Only limited budget information is required
and any budget adjustments made by the Initial Review Group will be in modules
of $25,000.

More detailed information about modular grant applications, including a sample
budget narrative justification pages and a sample biographical sketch, is
available via the Internet at:
http://www.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Background

Stroke is the leading cause of disability in the United States and is the third
leading cause of death nationwide after heart disease and cancer.  Recent
scientific advances have included drug therapy for the emergency treatment for
acute ischemic stroke and new imaging techniques that improve the ability to
diagnose strokes, to monitor and evaluate their progress, and to observe the
effects of treatment.  However, there is a need for research that addresses
effective nonpharmacological approaches to managing the initial events and
subsequent symptoms of a stroke.  This research would focus on reducing the
impairments, preventing secondary complications, and improving the functional
independence and the quality of life for the individual and family following a
stroke.

The rapid evaluation and treatment of stroke is necessary for improved outcomes
for stroke patients. Health care providers are recognizing the critical nature
of the first hours after the onset of a stroke and the need to identify those
eligible for thrombolytic therapy and other appropriate treatment regimens. A
national symposium sponsored by the National Institute of Neurological Disorders
and Stroke on the Rapid Identification and Treatment of Acute Stroke, concluded
that research is needed to continue to make improvements in the prehospital care
of stroke patients.  In addition, the need for collaborative research was
specified particularly in the areas of prevention, acute management, nursing care
and rehabilitation, and education.

Of the nearly 500,000 individuals annually who have a first-time stroke,
approximately 20 percent die in the first 3 (three) months and only 25 percent
recover fully.  The remaining 55 percent of the patients experience varying
degrees of disability, including a range of deficits in language, cognition, and
motor functions.

Recent Agency for Health Care Policy and Research (AHCPR) practice guidelines on
Post-Stroke Rehabilitation (Gresham, Duncan, Stason, et al., 1995) noted the
critical need for research related to caring for the nearly three million
Americans with some degree of disability from stroke.  The annual economic burden
is estimated to be more than $30 billion, a significant cost factor in addition
to representing an ongoing burden to the patient, to their families, and to
society.

Based on a careful analysis of nearly 2000 scientific articles related to stroke
rehabilitation research, the AHCPR panel concluded that the practice guideline
recommendations depended heavily on expert opinion since scientific evidence was
extremely limited.  The expert panel specified that additional research is
urgently needed, particularly in research whose goals are to: 1) identify the
characteristics of patients who are most likely to benefit from rehabilitation,
2) determine the optimal program for rehabilitation for different types of
patients, 3) identify factors that determine the optimal timing, intensity, and
duration of rehabilitation, 4) determine the effectiveness of specific treatments
or combinations of treatments in reducing impairments or improving function, and
5) develop and validate standardized tests for use in monitoring post-stroke
rehabilitation.  Recommendations were also made that encouraged well-controlled
experimental studies that assess functional performance and quality of life
outcome as well as studies that determine the cost effectiveness of various
strategies.

The AHCPR panel delineated specific areas of stroke management that were found
to lack adequate research evidence and thus needed to rely on expert opinion. 
In part, these included managing complications such as dysphagia, impaired skin
integrity, fall prevention, spasticity and contractures, seizure management, and
methods for early mobilization and return to self care. Inadequate research
evidence was also noted for practice guidelines related to factors such as
managing nutrition and hydration, bowel and bladder functioning, sleep
disturbances, sensorimotor deficits, impaired mobility, and impaired functional
performance, and pain.  Other areas needing study include managing cognitive and
perceptual deficits, emotional difficulties including depression, and speech and
language disorders.

Individuals who have experienced a stroke benefit from care that is
interdisciplinary and addresses a broad range of needs, including medical,
neurologic, psychologic, social, educational, vocational, and physical. The
context of patient care may include a variety of settings including homes,
community facilities, rehabilitation centers, acute care hospitals, assisted-
living sites, and long term care facilities.  Patient assessment needs careful
attention at all stages of the stroke experience and recovery in addition to
attention to continuity of care issues and optimal family involvement.

Objectives

Research areas that need to be explored include, but are not limited to:

o  techniques to improve assessment during the initial stroke event and at each
stage of recovery to guide nonpharmacologic treatment decisions and monitor
patient progress;

o  interventions to manage common symptoms, such as dysphagia, aphasia,  bowel
and bladder problems, sensorimotor deficits, depression, cognitive and perceptual
deficits as well as difficulties in nutrition, hydration, skin integrity, and
sleep;

o  strategies to determine optimal timing, intensity, and duration of
nonpharmacologic treatments;

o  methods to prevent secondary complications, improve function, and address the
sequelae of common comorbid conditions;

o  strategies to promote self-care in both activities of daily living and
instrumental activities of daily living and to enhance or maintain health
promotion activities;

o  measures to enhance family caregiving during all stages of recovery;

o  methods to improve care during transition from one setting to another and care
in specialized nurse managed units;

o  studies on the extent to which age and pre-existing conditions, such as
specific diseases, sensory, motor, and cognitive declines, influence treatment
outcome and management after stroke.

Selected References:

Gresham, G. E.; Duncan, P.W.; Stason, W.B., et al. Post-Stroke Rehabilitation.
Clinical Practice Guideline, No. 16. Rockville, MD:  U.S. Department of Health
and Human Services.  Public Health Service, Agency for Health Care Policy and
Research. AHCPR Publication No. 95-0662. May 1995.

National Institute of Neurological Disorders and Stroke, Office of Scientific and
Health Reports.  Setting New Directions for Stroke Care.  Proceedings of a
National Symposium on Rapid Identification and Treatment of Acute Stroke. 
Bethesda, MD:  National Institutes of Health, NIH Publication No. 97-4239, August
1997.

Additional information about the NCMRR's interest in stroke rehabilitation
research can be located in PA-99-041, Medical Rehabilitation Research, which was
published in the NIH Guide for Grants and Contracts, January 22, 1999, and is
available at the following URL address:
http://www.nih.gov/grants/guide/pa-files/PA-99-041.html

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

For research projects 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 was been published in the Federal Register of March 28,1994 (FR
59 14508-14513), and in the NIH Guide For Grants And Contracts, Vol. 23, No. 11,
March 18, 1994, available on the web at
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by NIH,
unless there are clear and compelling scientific and ethical reasons not to
include them. This policy applies to all initial (Type 1) applications submitted
for receipt dates after October 1, 1998.  All investigators proposing research
involving human subjects should read the "NIH Policy and Guidelines on the
Inclusion of Children as Participants in Research Involving Human Subjects" that
was published in the NIH Guide for Grants and Contracts, March 6, 1998 and is
available at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html

Investigators may obtain copy of these policies from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  These forms are available at most institutional offices of
sponsored research and 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: [email protected].

BUDGET INSTRUCTIONS

The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period. Items 8a and 8b should be completed indicating the Direct and Total Costs
for the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of
the PHS 398.  It is not required and will not be accepted with the application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required and
will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See http://www.nih.gov/grants/funding/modular/modular.htm for sample pages.) 
At the top of the page, enter the total direct costs requested for each year.

o Under Personnel, List key project personnel, including their names, percent of
effort, and roles on the project.  No individual salary information should be
provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct plus
facilities and administrative) for each year, each rounded to the nearest $1,000. 
List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project.  Indicate whether the collaborating institution is foreign or
domestic.  The total cost for a consortium/ contractual arrangement is included
in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall qualifications
of the research team.  A biographical sketch is required for all key personnel,
following the instructions below.  No more than three pages may be used for each
person.  A sample biographical sketch may be viewed at:
http://www.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List current position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations;
- Provide information, including overall goals and responsibilities, on research
projects ongoing or completed during the last three years.

o CHECKLIST - This page should be completed and submitted with the application. 
If the F&A rate agreement has been established, indicate the type of agreement
and the date.  It is important to identify all exclusions that were used in the
calculation of the F&A costs for the initial budget period and all future budget
years.

o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information is
necessary following the initial review.

APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE
TO THIS PA AND WILL BE RETURNED WITHOUT FURTHER REVIEW.

Applicants planning to submit an investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended/revised version of
the preceding grant application types requesting $500,000 or more in direct costs
for any year are advised that he or she must contact the Institute program staff
before submitting the application, i.e., as plans for the study are being
developed.  Furthermore, the application must obtain agreement from the staff
that the Institute will accept the application for consideration for award. 
Finally, the applicant must identify, in a cover letter sent with the
application, the staff member and Institute who agreed to accept assignment of
the application.  This policy requires an applicant to obtain agreement for
acceptance of both any such application and any such subsequent amendment.  Refer
to the NIH Guide for Grants and Contracts, March 20, 1998 at
http://www.nih.gov/grants/guide/notice-files/not98-030.html

The title and number of the program announcement must be typed on line 2 of the
face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and five signed photocopies in one package 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 comments, reviewers will be asked to discuss the following aspects of the
application 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 assigning the overall score, weighting them as
appropriate for each application.  Note that the application does not need to be
strong in all categories to be judged likely to have major scientific impact and
thus deserve a high priority score.  For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.

(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.  Is 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 to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research. Plans for
the recruitment and retention of subjects will also be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research.

o  The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project proposed
in the application.

The initial review group will also examine the provisions for the protection of
human subjects and the safety of the research environment.

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort.  The direct costs budget request will be reviewed for
consistency with the proposed methods and specific aims.  Any budgetary
adjustments recommended by the reviewers will be in $25,000 modules.  The
duration of support will be reviewed to determine if it is appropriate to ensure
successful completion of the requested scope of the project.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications. 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 scientific and programmatic issues to:

Karin F. Helmers, PhD
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD 20892-6300
Telephone: (301) 594-2177
FAX: (301) 480-8260
E-mail: [email protected]

John R. Marler, PhD
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2016
Bethesda, MD  20892-9525
Telephone:  (301) 496-9135
FAX:  (301) 480-1080
E-mail:  [email protected]

Judith A. Finkelstein, PhD
National Institute on Aging
Gateway Building, Suite 3C307
7201 Wisconsin Avenue, MSC 9205
Bethesda,  MD  20892-9205
Phone:  (301) 496-9350
FAX:  (301) 496-1494
E-mail:  [email protected]

Beth Ansel, PhD, CCC-SLP
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3461
FAX:  (301) 402-6251
E-mail:  [email protected]

Stephen A. Tuel, MSE, MD
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03
Rockville, MD  20852
Telephone:  (301) 402-2242
FAX: (301) 402-0832
E-mail:  [email protected]

Direct inquiries regarding fiscal matters to:

Jeff Carow
Grants Management Officer
National Institute of Nursing Research
Building 45, Room 3AN-12
6300 Center Drive MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
E-mail:  [email protected]

Gladys Bohler
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3254
Bethesda, MD  20892-9537
Telephone:  (301) 496-9231
FAX:  (301) 402-0219
E-mail:  [email protected]

Joe Ellis
Grants Management Officer
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
E-mail: [email protected]

Sharon Hunt
Grants Management Office
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
E-mail:  [email protected]

Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17G
Rockville, MD  20852
Telephone:  (301) 496-1304
E-mail:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Numbers
93.361 (NINR), 93.853 (NINDS), 93.866 (NIA), 93.173 (NIDCD) and 93.929
(NCMRR/NICHD).  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.

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