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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