Full Text AG-94-003

ENHANCING FAMILY CAREGIVING FOR ALZHEIMER'S DISEASE AND RELATED
DISORDERS

NIH GUIDE, Volume 23, Number 30, August 12, 1994

RFA:  AG-94-003

P.T. 34

Keywords: 
  Senile Dementia 
  0730052 


National Institutes on Aging

Letter of Intent Receipt Date:  October 1, 1994
Application Receipt Date:  November 29, 1994

PURPOSE

The National Institute on Aging (NIA) invites applications for
cooperative agreements for (a) sites to carry out social and behavioral
research on interventions designed to enhance family caregiving for
Alzheimer's Disease and related disorders (ADRD) and (b) a Coordinating
Center to provide coordination for this set of research projects.
Theory-based interventions may consist of psycho/social/educational
services (i.e., individual and/or family counseling by professionals or
peers), behavioral technology (skill-training), innovations in
community services (i.e., modifications in respite services, day care,
home care), high-tech environmental modifications (e.g., computerized
telephone systems, computer networks, etc.), or any combination of
these.  Given the paucity of controlled studies, this initiative is
designed to examine the feasibility and outcomes of different
intervention approaches rather than to provide definitive information
on the one best intervention strategy for enhancing dementia-specific
family caregiving.

This Request for Applications (RFA) supplements, but does not replace,
previous NIA program announcements on related issues (see NIH Guide for
Grants and Contracts Vol. 18, No. 6, February 24, 1989 for Alzheimer's
Disease and Related Disorders:  Issues in Caregiving).  In contrast to
a previous RFA on Special Care Units focused on institutional care,
this RFA will focus on characterizing and testing the most promising
home and community based interventions for enhancing family caregiving.
Because the caregiving experience in minority families has been
particularly neglected, applications that propose studies in
populations that are predominantly or totally of minority composition
are strongly encouraged.

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 RFA,
Enhancing Family Caregiving for ADRD, is related to the priority area
of older adults and preventive services.  Potential  applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic 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.  Due to the need for close
coordination and monitoring and the emphasis on caregiving in the
United States, no foreign or international components will be
considered in this RFA.  Applications from minorities and women are
encouraged.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program
will be a cooperative agreement (U01), an "assistance" mechanism
(rather than an "acquisition" mechanism) in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity.  Under the cooperative
agreement, the NIH purpose is to support and/or stimulate the
recipient's activity, working jointly with the award recipient in a
partner role, but it is not to assume direction, prime responsibility,
or a dominant role in the activity.  Details of the responsibilities,
relationships, and governance of the study to be funded under
cooperative agreement(s) are discussed under the section "Terms and
Conditions of Award."

Awards will be administered under PHS grants policy as stated in the
PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000,
revised April 1, 1994 and interim updates.

The duration for this research endeavor is five years.  Proposed
research should pose hypotheses or questions that can be successfully
addressed in this period.  The anticipated award date is August 1,
1995.  There may be a renewed U01 competition after the initial award
period to test more systematically, and in larger, more diverse
populations, the most successful interventions identified in the
initial investigations.  If the program of cooperative agreements is
not continued, the awardees may submit research grant applications to
extend the research funded by this initiative through the usual
investigator-initiated grants program.

FUNDS AVAILABLE

It is expected that up to $2,050,000 million (total cost) for first
year expenses will be available in Fiscal Year 1995 to fund five Sites
plus a Coordinating Center from applications submitted in response to
this RFA.  If an institution seeks to be selected as both a Site and a
Coordinating Center, separate applications must be filed for each
component, with distinct budgets that are independent of each other and
do not overlap in either objectives or budget items.  Institutions may
only apply for one Site and one Coordinating Center.  The requested
total funding (direct plus indirect costs) for the first year may not
exceed an average of $350,000 for Site applications and $300,000 for
Coordinating Center applications.  For the entire five-year project
period, total (direct plus indirect) costs requested per application
may not exceed $1.9 million for each Site and $1.6 million for the
Coordinating Center.  Within these limits, escalations after the first
year for recurring costs are limited to four percent per year.
Applications failing to meet these requirements will not be reviewed.
This level of support is dependent on the receipt of a sufficient
number of applications of high scientific merit.  Although this program
will be provided for in the financial plans of the NIA, the award of
grants pursuant to this RFA are contingent upon the availability of
funds for this purpose.

RESEARCH OBJECTIVES

Background

Approximately four million Americans are estimated to be afflicted with
Alzheimer's disease and related disorders (ADRD).  Costs associated
with care are largely reflected in the time spent by family members or
significant others caring for older persons with ADRD, most of whom are
cared for at home.

Caregivers of persons with ADRD often face a "triple jeopardy"; they
experience significant emotional stress, extreme physical and financial
burdens, and in some cases, also have to deal with apathy or even
hostility from the ADRD person.  These burdens often make caregivers
"hidden patients" who require outside assistance and support to
maintain their own health and functioning.

Family caregivers are an important resource that need special
attention.  Organizations such as the Alzheimer's Association have
developed an array of services and supports to preserve and enhance the
informal support network.  In association with chapters and local
agencies the Alzheimer's Association has designed programs that educate
and support caregivers in the decisions and challenges faced on a daily
basis.  Through programs such as the National Respite Care
Demonstration chapters work with volunteer and government agencies to
develop and expand respite care and other needed services at a local
level.

Other techniques and services designed to assist caregivers have been
suggested and developed.  While it is often unclear what specific
elements of proposed strategies are actually being tested or if any one
approach produces superior effects in either the caregiver or the
person with ADRD, research findings on caregivers of persons with ADRD
have identified several promising approaches for helping family
caregivers.  These include:

o  strategies to increase caregiver's knowledge of the disease or alter
perceptions of support (e.g., psycho-educational);

o  strategies to provide emotional support to the caregiver and to
assist in skill development;

o  strategies directed at changing or controlling the severity of
behavioral problems (wandering, agitation, etc.) which can lead to
deterioration in caregiver's physical and mental health;

o  the provision of external resources to strengthen caregiver supports
(community and home-based services);

o  new technological approaches designed to reduce emotional stress and
feelings of isolation, and to expand caregiver's repertoire of
problem-solving strategies (e.g., home-centered computer networks).

Research is needed to specify the components of designated
interventions and to begin to sort through the complex relationships
among types of interventions, caregiver and care receiver variables,
and intervention outcomes.  Systematic evaluations of strategies, or
combination of strategies, are needed to determine to what extent
different strategies are effective in enhancing family caregiving at
different stages in the progression of ADRD.  An understanding of the
theoretical underpinnings of different intervention strategies is
critical for implementing successful interventions in other populations
and settings.

Objectives and Scope

The primary goal of this RFA is to examine the effectiveness of social
and behavioral interventions to help family members care for
individuals with ADRD.  There is a need to direct research on
interventions that can broaden the options available to caregivers and
determine how formal care services intersect and complement informal
support networks.  The design of interventions and their assessment
require attention to the nature of the problem (e.g., enhancing
caregiver supports, strengthening caregiver skills, minimizing
caregiver responsibilities), the characteristics of the intervention,
and the processes which produce particular types of outcomes.  It is
desirable to establish standardized outcome measures, particularly
those of well-being and burden, to be used to assess the impact of
comparable strategies on caregivers and, secondarily, on care
receivers.  This RFA is not designed to support large scale
demonstration programs.  However, building a research component on
existing services or programs is appropriate if key definitions and
measures are not predetermined.

Specific Research Foci

Investigators must propose at least one social and behavioral
intervention designed to enhance family caregiving for persons with
Alzheimer's disease and related disorders.  Interventions need to be
based on theory driven models of care and its effectiveness.  While
this is not a drug study per se, investigators may propose a drug arm
as a comparison treatment strategy.  Proposed research designs must
rule out alternative explanations for intervention effects.  All
applicants must address:

The nature of the proposed intervention (e.g., type, intensity,
duration, frequency) and the underlying behavioral or social theory for
expected outcomes.  The conduct of previous research providing some
support for the effectiveness of the proposed intervention is
advisable.

Clinical, behavioral or social factors that might affect the impact of
the proposed intervention.  Investigators must identify and propose
standardized measurements for assessing key variables, such as disease
characteristics (e.g., stage of disease, presence of co-morbid
conditions); caregiving characteristics (nature and extent of
caregiving responsibilities; time in caregiving role); caregiver
characteristics (e.g., definition of primary caregiver; relationship to
care receiver).

Intervention outcomes for caregivers and care receivers (all
investigators must propose at least one primary health or functional
outcome for each that would be common across all Sites.  At least one
common measure of caregiver burden (or its obverse, caregiving
well-being) must also be identified.  Other outcomes may be proposed if
well justified and not burdensome for study participants).  The final
common measures will be determined by the steering committee from those
proposed at each site.

For those who propose more than one intervention, the comparison of
different interventions in terms of their health outcomes and relative
costs.

SPECIAL REQUIREMENTS

The broad areas of interest presented above are illustrative only as a
point of departure.  Studies proposed for Sites should include
discussion of design issues (including recruitment, attrition, and
selection bias), eligibility criteria, standardization of proposed
intervention, the content of baseline and follow-up assessments and
related statistical and data management issues.  Research plans should
indicate recommendations for common measurements, including the
rationale for measurement selection and frequency of assessment (e.g.,
it is likely than more than one annual assessment will be needed to
capture anticipated changes).  All prospective awardees should describe
strategies for the establishment of collaborative arrangements with
other awardees.

The initial meetings of awardees of all Components (Sites and
Coordinating Center) and NIH program staff will serve to coordinate the
individual research projects by developing operational definitions for
health and caregiver variables, determining the feasibility of adopting
common eligibility criteria and establishing a common data set for
baseline and follow-up assessments.  It is anticipated that
approximately nine months will be required for the development of a
protocol and the drafting of a manual of procedures for the generation
of the common data set.

The NIA program administrator will meet in Bethesda with Principal
Investigators and key staff up to four times in the first year and at
least every six months thereafter to discuss new developments, review
research progress and difficulties, coordinate ongoing research and
plan future research activities.  Applicants should include a statement
about their willingness to participate in such activities.  Travel
funds for key staff (two to three people) to attend these meetings
should be included as a budget line item in each application.

Organizational Components

1.  Intervention Sites

An intervention Site is the institution that receives an award for
conducting the investigation(s) under this RFA.  The Principal
Investigator (PI) is encouraged (as appropriate) to form a
multidisciplinary team.  Applications for individual Sites should
provide evidence of ability to recruit an adequate number of subjects
at each site in order to address the primary hypotheses about the
impact of the proposed psychosocial intervention(s).  There should be
evidence of strong institutional support for the Site and a stated
willingness to follow shared aspects of design, measures and analysis
as approved by the Steering Committee.  An organizational structure for
the Site should be set forth in the application, designating lines of
authority and responsibility.

2.  Coordinating Center

Applications are also requested for one Coordinating Center (CC) to
interact with the Sites, an Advisory Panel, and the NIA program
administrator on a variety of topics ranging from seeking and compiling
information, to providing technical assistance, to conducting
cross-site analyses.  In consultation with other organizational
components, the CC will have the primary responsibility for instrument
development and testing activities (e.g., compiling the listing of
proposed common measures; reviewing the literature and assessing the
advantages and disadvantages of different measures for common study
variables; conducting psychometric analyses on the common data set; and
making recommendations at the end of the study about the most
parsimonious set of measures to be archived).  Its staff may author
articles on measurement and statistical issues, alone or in conjunction
with others involved in this cooperative agreement.

Additionally, the CC will be responsible for tracking recruitment and
retention across the different Sites, and advising the Sites on
strategies for enhancing recruitment/retention, especially in minority
or ethnic populations.  The CC will also have the responsibility of
standardizing data collection and management and analysis of the common
data set.  It will work with projects to maximize the potential for
cross-site comparability of data; and, ensure that common protocols and
definitions are consistent across projects through training sessions.
It will provide key assistance in designing the data collection system
(e.g., centralized and/or distributive) for the shared data and will
also be responsible for developing and monitoring quality control.  The
CC will be responsible for printing and distributing all final data
collection forms.  Visits to Sites to set up common data systems should
be described and budgeted.  Its staff will collect, edit, store, and
analyze shared data generated by the Sites and participate with other
awardees as co-authors in preparing manuscripts that report results
from the common data set.

The CC will have primary responsibility for performing cross-site
analyses to evaluate the relative outcomes of different site-specific
interventions (e.g., through pre-planned meta-analyses). In addition,
the CC will perform a variety of functions, such as, developing a
cross-project Manual of Procedures; maintaining a directory of
investigators and co-investigators; arranging all conference calls and
meetings, e.g., for the Steering Committee and ad-hoc meetings of
project directors; and facilitating information exchange among the
Sites and NIH, and between the NIH and the general research community.
The latter role will include compiling specific reports and developing
and implementing common formats across Sites for all reports, protocols
and descriptions (e.g., progress reports, instrument protocols, manuals
of operation).  The CC will also devise plans for the dissemination of
information resulting from these studies, including the preparation of
slides for presentation of study objectives, methods, and findings.

The CC budget should include all costs required to convene the Advisory
Panel (8 members) at least once per year.  Up to $20,000 per year for
cross-site consultants and small working group sessions should also be
budgeted.  Two completely separate applications from different
applicant-investigators must be filed if an institution seeks selection
as both a Site and the Coordinating Center.

4.  Steering Committee

The Steering Committee will serve as the main decision-making body for
the shared aspects of the study.  The Steering Committee will have
overall responsibility for the study and will develop modifications in
the site-specific protocols to facilitate establishment of a common
data set using the information provided in this RFA as a guide.  The
Committee will consist of the Principal Investigator from each Site,
the Coordinating Center, and the NIA Program Administrator.  The
Steering Committee will meet every three to six months as needed.  The
chairperson, who will be someone other than an NIH staff member, will
be selected by the Steering Committee.

5.  Advisory Panel

An Advisory Panel (AP) will be selected by the Steering Committee to
serve in an advisory capacity to the study and to all of its
organizational components.  The functions of the AP include reviewing
project-specific and common core protocols and making suggestions to
the awardee(s) and the NIA Program Administrator; monitoring individual
project performance, using materials provided by the Coordinating
Center; monitoring protocols and information supplied through the
Coordinating Center for possible adverse effects associated with the
studies; reviewing and advising the awardee(s) and the NIA Program
Administrator regarding design and/or protocol changes requested by
individual investigators; and reviewing and advising the awardee(s) and
the NIA Program Administrator regarding analyses and publications
involving multi-project use of common core data.

The Panel will consist of experts in relevant clinical, social and
behavioral, statistical, and bioethical fields and will convene once
per year.  Interim conference calls and review of protocols and other
correspondence may be necessary between meetings.  Candidates should
not be contacted or recruited to serve on the Panel or be named prior
to the onset of the project.  However, applicants are encouraged to
enumerate areas of expertise appropriate for representation on the
Panel.  The experts must be independent of all Components participating
in the cooperative agreement (i.e., not scientifically or fiscally
involved).  A chair will be elected by members of the Advisory Panel
with input from the NIA Program Administrator.  The chairperson of the
Steering Committee, the Principal Investigator from the Coordinating
Center, and the NIA Program Administrator will all participate as
non-voting members during each Panel meeting.  Per NIH policy, Panel
members will be reimbursed for necessary travel and receive the
standard government honorarium for attendance at Advisory Board
meetings, but will not receive consultant fees for input to individual
projects.  Travel funds for members of the AP are to be included as a
line item in the budget of Coordinating Center applications.

Terms and Conditions of Award

The following special terms of award are in addition to, and not in
lieu of, otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Parts 74 and 92 and other HHS,
PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is a
cooperative agreement (U01), an assistance mechanism (rather than an
acquisition mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during
performance of the activity.  Under the cooperative agreement, the NIH
purpose is to support and/or stimulate the recipient's activity by
working jointly with the award recipient in a partner role, but it is
not to assume direction, prime responsibility or a dominant role in
this activity.  Consistent with this concept, the dominant role and
prime responsibility for the activity resides with the awardee(s) for
the project as a whole, although specific tasks and activities in
carrying out the collaborative aspects will be shared among the
awardees and the NIA Program Administrator.

1.  Awardee Rights and Responsibilities

Awardees will have primary authorities and responsibilities to define
objectives and research design, and for participant recruitment and
follow-up, quality control, data analysis and interpretation, and for
preparation of publications from their site-specific protocols.  The
Sites will prepare a detailed manual of operations which will be
updated on a regular basis throughout the course of the award.
Awardees at the Sites shall retain custody of, and primary rights to
the site-specific data developed under their award, subject to
Government rights of access consistent with current HHS, PHS, and NIH
policies.  A condition of this RFA is that all Sites agree to make
their Site-specific data publically available within a year of the end
of the initial funding period by placing the data in an archive, such
as the National Archive for Computerized Data on Aging at the
University of Michigan.  In addition, awardees of all organizational
components (Sites and Coordinating Center) will engage in collaborative
activities through participation in Steering Committee meetings and
conference calls in the development and implementation of a common
protocol establishing a shared data set.  During the course of the
award, data for the shared data set will be submitted at regular
intervals (e.g., bi-weekly or monthly) to the Coordinating Center where
it will be made available for cross-site analyses and archived for
public use within a year after the end of the initial award period.
Protocols developed by the Steering Committee will define rules
regarding access to data and publication of findings from analysis of
the shared data set which will be available to the Sites, the CC, and
the NIH program administrator.  An Advisory Panel will be established
to serve in an advisory capacity to the study.

2.  Staff Responsibilities

The NIA Program Administrator will have substantial
scientific/programmatic involvement during conduct of this activity,
through technical assistance, advice and coordination above and beyond
normal program stewardship for grants.  The awardee agrees to accept
assistance from the NIA Program Administrator, as described below:

o  Participation in the development of the protocol for common measures

o  Monitoring of performance issues relating to steering committee
assignments necessary for the development of the common protocol,
recruitment, follow-up, quality control, adherence to protocol and
attainment of study objectives.

o  Providing technical assistance in the formulation or consideration
of refinements and adjustments of study objectives, designs and
protocols.

o  Assistance in analysis and reporting of intervention study results

The NIA Program Administrator may provide advice on staffing,
statistical requirements, and will cooperate with awardees in
considering protocol adjustments.  In instances where there has been
significant involvement in study design and analysis by the NIA Program
Administrator, and in accordance with Publication Guidelines developed
by the Steering Committee and with NIH policies regarding staff
co-authorship of publications resulting from extramural awards, he/she
may cooperate with awardees as co-authors in preparing manuscripts that
report results from these studies.

3.  Collaborative Responsibilities

A Steering Committee, composed of the Principal Investigators of each
Site, the Principal Investigator of the Coordinating Center, and the
NIA Program Administrator will be the main governing board of the study
and will have primary responsibility for developing a protocol for the
shared aspects of the study.  The Steering Committee will develop
modifications in the site-specific protocols to facilitate
establishment of a common data set using the information provided in
this RFA as a guide.  The Steering Committee will also establish
subcommittees to oversee major operational components of the study.
One vote will be given to each Principal Investigator and to the NIH.
The Steering Committee will meet every three to six months as needed.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award), between award recipients and the NIH
may be brought to arbitration.  An arbitration panel will be composed
of three members -- one selected by the Steering Committee (with the
NIH member not voting) or by the individual awardee in the event of an
individual disagreement, a second member selected by the NIH, and the
third member selected by the two prior selected members.  This special
arbitration procedure in no way affects the awardee's right to appeal
an adverse action that is other wise appealable in accordance with the
PHS regulations at 42 CFR part 50, subpart D and HHS Regulation at 45
CFR part 16.

STUDY POPULATIONS

Persons with medical diagnoses of ADRD, at the mild or moderate level,
are the preferred target group as are caregivers who are at increased
risk due to burdens of care.  All awardees should provide their working
definition of a "primary caregiver"; while theoretically interesting
attention to "secondary" and "tertiary" caregivers is optional.
Conceptual and analytical attention should be paid to anticipated
changes in the health and functioning of the person needing care for
ADRD as well as in caregiver responsibilities and roles.  The proposed
timing and frequency of data collection for proposed outcome measures
should be indicated and related to projected rates of change.  Although
research designs are expected to vary according to specific
interventions being examined, baseline common core data should be
collected and transmitted to the coordinating center as soon as
available, beginning no later than the start of the second year of the
project.

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 new policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43)
and supersedes and strengthens the previous policies (Concerning the
Inclusion of Women in Study Populations, and Concerning the Inclusion
of Minorities in Study Populations) which have been in effect since
1990.  The new policy contains some new provisions that are
substantially different from the 1990 policies.  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 reprinted in the NIH GUIDE
FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the program
staff or contact person listed below.  Program staff may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are strongly encouraged to submit, by October 1,
1994, a letter of intent that includes a descriptive title of the
proposed research, the name, address, and telephone number of the PI,
the identities of other key personnel and participating institutions,
and the number and title of the RFA in response to which the
application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
allows NIA staff to estimate the potential review workload and to avoid
conflict of interest in the review.

The letter of intent is to be sent to Dr. Marcia G. Ory at the address
listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the PHS 398 (rev. 9/91) application
form.  This form is available at most institutional offices of
sponsored research; from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 5333 Westbard Avenue,
Room 449, Bethesda, MD 20892, telephone (301) 710-0267; and from the
NIH program administrator listed under INQUIRIES.

Essential information on budgets and direct and indirect cost limits is
discussed under FUNDS AVAILABLE, budget information on travel for
steering committee meetings is discussed under SPECIAL REQUIREMENTS,
and budget information about travel to advisory committee meetings is
under the description of the advisory committee.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  If so, a letter of agreement from either the GCRC program
director or Principal Investigator must be included with the
application.

The RFA label available in the application kit must be affixed to the
bottom of the face page of the application.  Failure to use this label
could delay processing of the application such that it may not reach
the review committee in time for review.  In addition, the RFA title,
number, and type of application: "Site," "Coordinating Center,"  must
be typed on line 2a of the face page of the application form and the
YES box must be checked.

Submit a signed, original of the application, including the Checklist,
and three signed, exact photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

Two copies of the application with appendices must also be sent to:

Chief, Scientific Review Office
National Institute on Aging
Gateway Building, Suite 2C212
Bethesda, MD  20892

The deadline for receipt of applications is November 29, 1994.
Materials will not be accepted after this date.  If an application is
received after that date, it will be returned to the applicant.  The
Division of Research Grants (DRG) will not accept any application in
response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application.  Nor will the DRG accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing
the previous critique.

Applicants must obtain Institutional Review Board (IRB), and if
applicable, Institutional Animal Care and Use Committee approval of
their application prior to submission.  Applications not having these
approvals are incomplete and will be returned without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by NIH staff for
completeness and responsiveness.  Incomplete and nonresponsive
applications will be returned to the applicant without further
consideration.  Applications that are complete and responsive to the
RFA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the NIA in accordance with
the review criteria stated below.  As part of the initial merit review,
a process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications received
in response to the RFA.  Applications judged to be competitive will be
discussed and be assigned a priority score.  Applications determined to
be non-competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.  The second level of review will be
provided by the National Advisory Council on Aging.

The major review criteria to be used in the evaluation of applications
for all Sites are:  significance of the proposed activities to the
goals of the RFA; qualifications, experience and commitment of the
investigators and their ability to devote the required time and effort
to the project; an understanding of the scientific objectives of the
program, as evidenced by discussion of issues relating to the design
and implementation of the collaborative aspects of the program;
adequacy of inclusion of women and minorities; the willingness to work
collaboratively with other awardees and with the NIA program
administrator in the manner summarized in the RFA; institutional
commitment to the requirements of the project; and appropriateness of
the total budget and budgetary requests.

Substantive review criteria for Sites are: evidence of a conceptual
model driving the selection of the proposed intervention(s);
specification of the selected intervention (e.g., type, frequency,
intensity, and duration); justification for proposed sample sizes,
assurance that projected sample sizes can be obtained, estimates of
subject attrition; designation of measures to be included in the common
data set, with rationale for the selection of primary and secondary
outcome measures; and specification of analysis plans, with evidence of
adequate statistical and data management support for site-specific data
collection and analysis.

Review criteria for the Coordinating Center are: prior experience in
functioning as a Coordinating Center in a multi-site study; experience
of the Principal Investigator and other key personnel in instrument
development and psychometric testing, data management, statistical
analysis, quality control, study coordination and administrative
aspects of multi-center clinical studies; and proposed data collection
and monitoring system.  Substantive familiarity with dementia and
family caregiving issues is desirable.

AWARD CRITERIA

Applications recommended by the National Advisory Council on Aging and
other relevant council(s) will be considered for award based upon (a)
scientific and technical merit; (b) program balance, including in this
instance, sufficient compatibility of features to make a successful
collaborative program a reasonable likelihood; (c) adequate inclusion
of women and minorities in the common studies; and (d) availability of
funds.

Letter of Intent Receipt Date:  October 1, 1994
Application Receipt Date:       November 29, 1994
Council Review:                 May 25, 1995
Anticipated Award Date:         August 1, 1995

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  Direct inquiries regarding programmatic issues
to:

Dr. Marcia G. Ory
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, Room 533
Bethesda, MD  20892
Telephone:  (301) 496-3136

Direct inquiries regarding fiscal matters to:

Ms. Joanne Colbert
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Room 2N212
Bethesda, MD  20892
Telephone:  (301) 496-1472

Other institutes and agencies are also interested in research dealing
with Alzheimer's disease and related disorders.  For information
concerning related research interests, contact:

National Institute of Nursing Research, Dr. Mary Lucas, Westwood
Building, Room 754, Bethesda, MD 20892, (301) 594-7397

National Institute of Mental Health, Dr. Enid Light, Parklawn Building,
Room 7103, Rockville, MD 20857, (301) 443-1185

Agency for Health Care Policy and Research, Ms. Linda Siegenthaler,
2101 E. Jefferson St, Room 502, Rockville, MD 20852, (301) 594-1357

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.866 (Aging Research).  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 Part 52 and
45 CFR Parts 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use of
all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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