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:
GrantsInfo@nih.gov.
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: nell_armstrong@nih.gov
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: nell_armstrong@nih.gov
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:garfields@extra.niddk.nih.gov
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: Marcia_Ory@nih.gov
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: BryantP@de45.nidr.nih.gov
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: robert_tarwater@nih.gov
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: chickc@extra.niddk.nih.gov
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: Bob_Pike@nih.gov
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: Martin_Rubinstein@nih.gov
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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