and Human Services (HHS)
EXPIRED
ENHANCING ADHERENCE TO DIABETES SELF-MANAGEMENT BEHAVIORS Release Date: January 27, 2000 PA NUMBER: PA-00-049 National Institute of Nursing Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Aging National Institute of Dental and Craniofacial Research THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE This Program Announcement (PA) solicits applications for investigator- initiated research related to sociocultural, environmental, and behavioral mechanisms and biological/technological factors that contribute to successful and ongoing self-management in diabetes. Self-management is defined as client strategies and behaviors that contribute to blood glucose normalization, improved health, and prevention or reduction of complications. It is broader than adherence to specific regimen components and incorporates deliberate problem solving and decision making processes. Applications are encouraged for both type 1 and type 2 diabetes, representative and minority populations, and all age groups. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. This Program Announcement (PA), Title of PA, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. 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 5 years. 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 Institute or Center (IC) program staff (see INQUIRIES, below) before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from IC staff that the IC 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 or Center 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 subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 (http://grants.nih.gov/grants/guide/notice-files/not98-030.html). Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm RESEARCH OBJECTIVES Background Although more effective medications, delivery devices and methods for diabetes self monitoring have improved the ability to control glycemia, normal metabolic control remains difficult to achieve. Results from the Diabetes Control and Complications Trial (DCCT) have shown that improving blood glucose control in type 1 diabetes, in which the body produces no insulin to regulate blood glucose levels, markedly reduces related complications of the eyes, kidneys, and nerves. Results from the United Kingdom Prospective Diabetes Study (UKPDS) has similarly demonstrated that improved control of blood glucose in type 2 diabetes also reduces diabetes related complications. Both type 1 and type 2 diabetes require careful self-management and both can lead to acute and chronic complications compromising health and quality of life. Often multiple self-care regimens are required to manage the diabetes and help prevent, detect, or reduce complications. All age, socioeconomic, and ethnic groups are affected. Type 1 diabetes results from an autoimmune destruction of insulin-producing beta cells in the pancreas, thereby leading to a lack of insulin. Current methods of insulin replacement cannot replicate the normal pancreatic beta cell ability to precisely control blood glucose metabolism. In type 2 diabetes, the metabolic problem is related to certain tissues resistance to insulin action and to inability of the pancreas to appropriately regulate the pattern and quantity of insulin for glucose metabolism. These metabolic abnormalities lead to the many complications of both types of diabetes. Type 2 diabetes has always been more prevalent than type 1 and has occurred predominantly in adults aged 40 and over. A trend has developed in the last ten years, however, indicating that children and adolescents are increasingly susceptible to type 2 diabetes. This trend is particularly evident in minority ethnic groups, especially in African Americans and American Indians. The increase in U.S. citizens, including children and adolescents, who are overweight may be contributing to this trend. With both types of diabetes becoming more prevalent in the population, and with the associated risk for serious complications, issues related to proactive self-management become a greater concern. Chronic diabetes complications are many and varied. Microvascular complications include retinopathy, nephropathy, and peripheral or autonomic neuropathy. These complications can lead to vision impairment or blindness, the need for kidney dialysis or transplant, and limb amputations. Macrovascular complications include cardiac, cardiovascular, and peripheral vascular diseases. Other problematic comorbidities can occur, including, for example, periodontal disease (that may lead to early tooth loss) or respiratory infections. These diseases and their impact on metabolic control, personal lifestyle, work productivity, the society as a whole, and health care costs underscore the need to develop more efficacious and effective diabetes self management interventions. The most common acute complication of diabetes is hypoglycemia which can range from mild to severe. Hypoglycemia can occur more often with tighter (more normal) blood glucose control. This can lead to conflict for the individual between the recognized need for normal blood glucose levels versus the fear or concern about having a hypoglycemic reaction at work or school, while driving, or in any social situation. The resulting loss of control of mental function with hypoglycemia due to confusion or decreasing awareness can lead to avoidance of hypoglycemia by overeating or underexercising. Self-management decisions related to the needs for both blood glucose control and as normal a lifestyle as possible can be problematic for the individual, the family, and health care providers. Coping with a complex chronic illness such as diabetes affects the individual as well as family members throughout the entire life-course. The daily responsibilities and knowledge of the risk for serious complications such as blindness, amputations, and heart disease, place a heavy burden of self-care on individuals with diabetes. Persons with diabetes are faced with decision making that involves establishing priorities in allocating time, effort, and resources to attain multiple types of health care (e.g., nursing, medical, ophthalmic, dental, nutrition, and podiatry). In general, much of the responsibility for managing diabetes falls on the individuals themselves, whose responsibilities, in addition to usual health maintenance, include regimens of meal planning and timing, physical activity, blood glucose monitoring, management of acute complications, and adjustments in therapies and lifestyle behaviors. Family members and family life, however, are also affected by the disease. Family members have greater responsibility for participating in diabetes care when the person with diabetes is a child, adolescent, or dependent older adult. The report of a national conference on diabetes convened by NIH in 1997 suggests that insight into the behavioral barriers that prevent application of effective therapies and the development of the means to lower those barriers will help to implement current and future therapies. A Congressionally- established Diabetes Research Working Group developed a comprehensive plan for diabetes research priorities in 1999. The recommendations include studies related to the optimization of glucose control and the need for behavioral research. The report notes that in many cases, successful metabolic control and prevention of complications depends on changing the behaviors of patients, providers, and persons at risk for development of diabetes. The DCCT, UKDPS, and a recent meeting3 at NIH on behavioral science research in diabetes all stress the need to extend research on self-management, adherence, and other biopsychosocial aspects of diabetes management to assist persons with diabetes to achieve normal blood glucose levels, to reduce complications, and to improve their quality of life. The investigation of factors associated with effective and long-term diabetes self-management is critical to improving diabetes health outcomes. This announcement is aimed at meeting the diabetes self-management research needs. Scope Translational and patient-oriented research on self-management and adherence in diabetes that affects both psychosocial and biophysiological outcomes is solicited through this program announcement. This announcement solicits proposals on both type 1 and type 2 diabetes populations and all age groups and ethnic backgrounds. Research is needed to develop effective methodologies for promoting sustained adherence to appropriate diabetes self-management behaviors. Intervention proposals are particularly solicited, especially those to test approaches that are feasible and cost effective to translate into practice. Objectives Research areas specific to diabetes self-management that need to be explored include, but are not limited to: o identification of critical intervention components in promoting sustained, effective diabetes self-management to improve glycemic control and reduce a wide array of complications, o factors related to degree of success with sustained intensive self- management (examples: coping styles, social support strategies/systems, personality dispositions, burden of care, stress, impact on quality of life, economic considerations, health outcomes), o intervention strategies with a defined focus on cultural, ethnic, lifestyle, and age-related factors (examples: how do intervention strategies need to be tailored to be optimally effective for (1) persons with life-long diabetes versus those with late-life onset, (2) persons who have long, intense work hours, persons with health beliefs at variance with mainstream beliefs?), o strategies that promote quality of life or that ease the psychosocial burden of diabetes on individuals and their families, o intervention strategies that promote effective self-monitoring, problem solving, and decision making in addition to routine diabetes management actions (examples: processes underlying decisions related to working with health care providers, for both primary and collateral health care, self- management decisions and problem solving), o interdisciplinary team or health care provider roles and relationships with the person with diabetes to support shared decision making and successful self-management, o supporting strategies of the health care delivery system in promoting diabetes self-management (specifically in conjunction with other interventions), o strategies that promote behavior change in sub-populations that have significant difficulties (examples: adolescents, children, obese individuals, frail elders, low-income, hard-to-reach inner-city, rural, ethnic groups), o integrating technologies into self-management strategies (examples: glucose monitoring, computer based communications/strategies, insulin pump). 1. National Institutes of Health (September, 1997). Diabetes Mellitus: Challenges and Opportunities. Final Report and Recommendations. Bethesda, MD. 2. Congressionally-Established Diabetes Research Working Group. (1999). Conquering Diabetes: A Strategic Plan for the 21st Century. Bethesda, MD: NIH Publication No. 99-4398. 3. National Institutes of Health (November, 1999) Behavioral Science Research in Diabetes meeting. Presented by National Institute of Diabetes and Digestive and Kidney Diseases and the Office of Behavioral and Social Sciences Branch, NIH. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://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 the NIH, unless there are 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://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NOTE FOR APPLICATIONS FOCUSED ON AGING RESEARCH Some applications received in response to this program announcement are expected to focus on scientific issues related to aging and to aging-related aspects of disease. In describing the plan to recruit human subjects investigators may cite a focus on aging or on aging-related aspects of disease as the justification for why children will be excluded. In this regard applicants may use Justification 1, the research topic to be studied is irrelevant to children, from the policy announcement. APPLICATION PROCEDURES 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 or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC 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 or Center 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://grants.nih.gov/grants/guide/notice-files/not98-030.html The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS398 application 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 - Prepare a Modular Grant Budget Narrative page. (See http://grants.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. This is not a Form page. 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. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. 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. Include the Letter of Intent to establish a consortium. 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://grants.nih.gov/grants/funding/modular/modular.htm. Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, 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. All appropriate exclusions must be applied 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. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. 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 will be evaluated for scientific and technical merit by an appropriate scientific 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 and undergo a process in which only those applications 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. 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: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? 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. Additional scientific/technical merit criteria specific to the objectives of the PA and the mechanism used must be included if they are to be used in the review. AWARD CRITERIA Applications will compete for available funds with all other recommended 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 strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding GENERAL ISSUES to: Dr. Nell Armstrong Office of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5973 FAX: (301) 480-8260 Email: [email protected] Direct inquiries regarding specific PROGRAMMATIC ISSUES to the staff of the appropriate Institute/Center : Dr. Nell Armstrong Office of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5973 FAX: (301) 480-8260 Email: [email protected] Dr. Sanford Garfield Senior Advisor for Biometry and Behavioral Research National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN24B 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8803 Fax: (301) 402-6271 E-mail:[email protected] Dr. Marcia Ory Behavioral and Social Research National Institute on Aging Gateway Building, Room 533 7201 Wisconsin Ave MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 Fax: (301) 402-0051 E-mail: [email protected] Dr. Patricia Bryant Program Director, Behavioral and Health Promotion Research Office of Clinical, Behavioral, and Health Promotion Research National Institute of Dental and Craniofacial Research Building 45, Room 4AN24E 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2095 FAX: (301) 480-8318 E-mail: [email protected] Direct inquiries regarding FISCAL MATTERS to: Mr. Robert Tarwater Office of Grants Management National Institute of Nursing Research Building 45, Room 3AN24 45 Center Drive, MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-2807 FAX: (301) 480-8260 Email: [email protected] Ms. Cheryl Chick Office of Grants Management National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AN38J 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8825 Fax: (301) 480-4237 E-mail: [email protected] Mr. Bob Pike Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Ave, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Fax: (301) 402-3672 E-mail: [email protected] Mr. Martin Rubinstein Office of Grants Management National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44A 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone (301) 594-4800 FAX: (301) 480-8301 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361 (NINR), 93.847 (NIDDK), 93.121 (NIDCR), 93.866 (NIA). 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 NIH grants policies and Federal Regulations 42 CFR 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 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, and 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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