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Reducing Risks in Diabetes Self-managementA Systematic Review of the LiteratureFrom the Health Services Research & Development Program, Harry S. Truman Memorial Veterans Hospital, Columbia, Missouri, and the Center for Health Care Quality (Dr Boren); Department of Health Management & Informatics, School of Medicine, University of Missouri, Columbia (Dr Boren, Ms Gunlock); Center for Health Care Quality, School of Medicine, University of Missouri, Columbia (Ms Gunlock); Center for Health Studies, Group Health Cooperative, Seattle, Washington (Ms Schaefer); and Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia (Dr Albright). Correspondence to Suzanne Austin Boren, PhD, MHA, Health Services Research and Development, Harry S. Truman Memorial Veterans Hospital, 800 Hospital Drive, Columbia, MO 65201 (borens{at}health.missouri.edu).
Objective The purpose of this systematic review was to review published literature on risk-reducing interventions as part of diabetes self-management. Data Sources Medline (1990-2007), CINAHL (1990-2007), and Cochrane Central Register of Controlled Trials (first quarter 2007) databases were searched. Reference lists from included studies were reviewed to identify additional studies. Study Selection Intervention studies that addressed reducing risks to help prevent or minimize diabetes complications were included. Data Extraction Study design, sample characteristics, interventions, and outcomes were extracted. Data Synthesis Thirty-three studies, represented by 39 articles, met the criteria for inclusion and were classified as smoking cessation (n = 3), eye examination (n = 2), foot care (n = 10), oral health (n = 2), vaccination (n = 1), cardiovascular risk reduction (n = 9), and comprehensive risk reduction (n = 6). Only 46.3% of the 283 outcomes measured in the 33 studies were significantly improved. Conclusions Reducing risks involves implementing effective risk reduction behaviors to prevent or slow the progression of diabetes complications. Recognizing risk factors for complications and what constitutes optimal preventive care is an important part of managing diabetes. Intervention studies are lacking in some areas of reducing risks. Further studies are needed to test specific interventions to reduce the risks of diabetes complications.
Reducing risks is defined in the AADE7 Self-Care BehaviorsTM as people with diabetes implementing effective risk reduction behaviors to prevent or slow the progression of diabetes complications.1 Efforts to improve diabetes care by reducing risks are ongoing.1-3 Diabetes care processes and outcomes have improved over the past 10 years, but currently 1 of 5 persons with diabetes has poor glycemic control, 1 of 3 has poor blood pressure control, and 2 of 5 have poor low-density lipoprotein (LDL) cholesterol control.4 Diabetes self-management education is important in promoting health practices and reducing risks of complications. A Behavioral Risk Factor Surveillance System (BRFSS) survey conducted in 2001 and 2002 of 22 682 persons with type 2 diabetes found that only 52% had attended a diabetes self-management education program.5 The need for education is great: as many as 50% to 80% of persons with diabetes have significant knowledge deficits for managing their disease,6 and patients with no diabetes education are 4 times more likely to develop complications.7 For example, a study focusing on eye exams for persons with diabetes discovered that more than 50% of the participants did not know that eye complications may be asymptomatic and that there are ways to lower the risk of eye problems, 20% did not know what type of health provider should perform an eye exam, and 17% did not know that annual eye exams were recommended.8 A BRFSS survey during 2002 through 2004 observed that only 4 in 10 adults with diabetes received an annual foot examination, an eye examination, and a biannual glycosylated hemoglobin (HbA1c) test.9 A BRFSS survey in 2001 observed that only 65.9% of adults with diabetes had a dilated eye exam in the past year, 62.3% had a health professional check their feet for any sores or irritation, 55.8% had monitored their blood glucose at least once daily, 43.5% had an influenza vaccination in the past 12 months, and 35.0% ever had a pneumococcal vaccination.10 Persons who received diabetes self-management education were significantly more likely than those who had not received education to be physically active, to have received an annual dilated eye exam, to have received a flu vaccine, to have received a pneumococcal vaccine, to have checked their blood sugar daily, and to have had a physician or other health professional check their feet for sores or irritations and their hemoglobin A1C level in the past year.5 The AADE7 Self-Care BehaviorsTM framework defines the following skills to be taught to people with diabetes as interventions that reduce diabetes complications and maximize health and quality of life: smoking cessation, foot inspections, blood pressure monitoring, self-monitoring of blood glucose, aspirin use, maintenance of personal care records, and regular eye, foot, and dental examinations.3 The purpose of this systematic review of the literature was to compile and evaluate published evidence for reducing risks as part of a diabetes self-management education program.
Search Medline (1990-2007), CINAHL (1990-2007), and the Cochrane Central Register of Controlled Trials (first quarter 2007) databases were searched using combinations and variations of the following search terms: (1) diabetes mellitus, type 1 diabetes mellitus, type 2 diabetes mellitus, or diabetes complications; (2) self-care, patient education, health education, health promotion, disease management, counseling, risk assessment, risk factors, and risk reduction behavior; and (3) (a) smoking, smoking cessation, tobacco, tobacco use cessation, or (b) diabetic retinopathy, or (c) diabetic foot, foot diseases, diabetic neuropathies, or (d) periodontal disease, dental care, dental scaling, root planing, or (e) immunization, vaccination, human influenza, pneumonia, or (f) cardiovascular diseases, diabetic angiopathies, hypertension, blood pressure, platelet aggregation inhibitors, aspirin, dyslipidemias, hyperlipidemias, or (g) diabetic nephropathies, or (h) medical records; and (4) randomized controlled trials, intervention studies, clinical trials, and controlled clinical trials. In an attempt to include higher quality studies, our inclusion criteria were limited to studies evaluating a diabetes self-management intervention that aimed to reduce risks. We excluded studies published prior to 1990 or if they were not written in English. In addition, preventive care services and self-management skills that reduce risks and are directly related to other AADE7TM Self-Care Behaviors are not covered in this review. For example, managing blood sugar is covered in monitoring, managing stress is covered in healthy coping, diet is covered in healthy eating, exercise is covered in physical activity, and medicine is covered in taking medication.
Selection and Validity Assessment
Data Extraction
Trial Flow Literature searches identified 308 articles. The number of articles identified and excluded at each stage of the search and selection process is presented in Figure 1. Articles were excluded after reading the title and abstract or after reading the full article for the following reasons: not pertinent to diabetes (n = 20), not pertinent to reducing risks (n = 150), no intervention or intervention not targeted to patients (n = 62), or content was descriptive or opinion (n = 37). As a result, 39 articles representing 33 studies were included in the review.
Study Characteristics The sample size of the studies ranged from 40 to 21 647, with a median of 186. Two (6.1%) of the studies examined children and/or adolescents, and 31 (93.9%) examined adults. Persons with type 1 diabetes were included in 1 study (3.0%), persons with type 2 diabetes were included in 12 studies (36.4%), and persons with type 1 or type 2 diabetes were included in 13 studies (39.4%). Seven studies (21.2%) did not report diabetes type. One study (3.1%) included women only, 26 studies (78.8%) included both genders, and 6 studies (18.2%) did not report the gender makeup. With regard to race/ethnicity of patient samples, 22 studies (66.7%) did not report the ethnicity of participants, 2 studies (6.1%) included African American participants, 1 study (3.1%) included Asian participants, 8 studies (24.2%) included multiple races/ethnicities (generally Caucasian, African American, Latino), and 10 studies (30.3%) were international (Germany, Finland, Australia, Hong Kong, United Kingdom, Turkey, Israel, and New Zealand). Twenty-five studies (75.8%) had patients as the intervention target, 1 study (3.0%) focused on clinicians, and 7 studies (21.2%) focused on both patients and clinicians.
Study Quality
Data Synthesis
Smoking cessation. Three studies dealt with smoking cessation (Table 1).19-21 The interventions included education19-21 and behavior therapy.21 Two of the trials also included follow-up telephone calls for additional counseling.19,20 Behavior change, the most common outcome group category, was measured in various ways, including self-reported smokers who quit,19 urine cotinine-verified smokers who quit,19 patients in precontemplation stage,19 patients in contemplation stage,19 patients in action and maintenance stages,19 patients in relapse stage,19 change in mean cigarettes per day,19 percentage who smoked in the past 7 days,20 percentage who smoked daily,20 and confirmation of nonsmokers.21 Of these behavior outcomes, all revealed a significant improvement, except the percentage who smoked in the past 7 days20 and confirmation of nonsmokers.21 In addition, clinical outcomes were assessed by A1c and plasma lipid values,20 but neither revealed a significant improvement. Health status was assessed through a self-efficacy score20 but failed to show a significant change. Overall, 2 of the 3 studies19,20 saw a significant change in at least 1 outcome.
Eye examination. Two studies concerned the improvement in performance of a dilated eye exam (Table 2).22,23 Patients in the intervention groups in both of these studies received multiple educational interventions. In 1 study, the intervention patients viewed a videotape and received telephone education in addition to printed materials.22 In the other study, the intervention patients received reminders in addition to printed materials.23 Both studies measured the behavior change outcome of whether patients received a dilated eye exam. The first measured whether patients received a retinal eye exam at 6 months and identified a significant improvement in the intervention group compared with the control group. The second measured dilated eye exam rates at 6 months, 11 months, and 12 months, but significant improvement in the intervention group was only seen at the 12-month measure.
Foot care. Ten studies represented by 12 articles dealt with proper foot care (Table 3).12,16,24-33 The foot care interventions involved therapeutic footwear,16,31,32,34 foot education,12,25,26,28,32,33 professional foot evaluation,31,32 behavioral interventions,12 reminders or professional practice guidelines,12 and exercise training.24 All of the studies that measured foot care revealed a significant improvement in at least 1 foot care outcome.
Learning outcomes were measured in various ways, including knowledge scores,28,29 self-care scores,28,29 foot care knowledge,25-27 and a knowledge inventory form.30 All of these outcomes revealed a significant change except the knowledge inventory form30 and the patient knowledge of diabetic foot care score.27 Behavior changes were also assessed in a variety of ways, which included the use of special insoles,28,29 wash feet,12 no soaking of feet,12 inspect feet,12 inspect shoes,12 dry between toes,12 file calluses,12 lubricate feet,12 cut nails,12 report problems to physician or nurse,12 test water temperature,12 see podiatrist,12 wear socks,12 physician's documentation of various clinical measures,12 foot care routine compliance,25 compliance with advice to consult a podiatrist,25 foot care practices,26,30 ownership and use of therapeutic shoes,16 wore therapeutic shoes to walk outside,16 bought therapeutic shoes,16 renewed prescription of shoes,16 use of lotion,33 daily foot inspections,33 and wearing appropriate shoes and stockings.33 Many of these behavior outcomes demonstrated a significant improvement after the foot care intervention, including the use of special insoles,28,29 wash feet,12 no soaking of feet,12 inspect feet,12 inspect shoes,12 dry between toes,12 file calluses,12 physician's documentation of various measures,12 foot care compliance,25 compliance with advice to consult a podiatrist,25 foot care practices,26 ownership and use of therapeutic shoes,16 daily foot inspections,33 use of lotion,33 daily foot inspections,33 and wearing appropriate shoes and stockings.33 In addition, many clinical outcomes were assessed, including the presence of ingrown toenails,12,28,29 diabetic foot complications,31,32 calosites,28,29 corns,28,29 other nail disorders,28,29 inability to spread out toes,28,29 inability to flex toes,28,29 diameter of greatest callosity in calcaneal region,28,29 diameter of greatest callosity in other regions,28,29 serious foot lesions,12 all foot lesions,12 dry or cracked skin,12 fungal nail infection,12 fungal skin infection,12 interdigit maceration,12 foot problems requiring treatment,12 nerve conduction velocity (NCV) parameters,24 diabetic peripheral neuropathy (DPN) development,24 vibration perception threshold (VPT) parameters,24 status of the patient's feet,30 risk factor scores for lower extremity ulceration,26 and HbA1c.30 Many of these clinical outcomes revealed a significant improvement after the foot care intervention, including diabetic foot complications,31,32 callosities in other regions,31,32 diameter of greatest callosity in other regions,31,32 serious foot lesions,12 dry or cracked skin,12 ingrown nails,12 fungal nail infection,12 foot problems requiring treatment,25 NCV parameters,24 PDN development,24 VPT parameters,24 and HbA1c.30 Health status outcomes were assessed through hospitalizations,33 amputations,33 overall attitude toward foot care,27 attitude toward self foot care,27 and attitude toward provided diabetic foot care,27 and a significant change was seen in all of these measures in the intervention group with the exception of attitude toward provided diabetic foot care.27 Oral health. Two studies dealt with proper oral health35,36 and included periodontal scaling and root planing in the interventions (Table 4). However, Kiran et al36 also included oral hygiene instructions in the intervention. Behavior outcomes were assessed in 2 measures: compliant with study time frame35 and percentage with a dental visit.35 However, neither of these measures revealed a significant improvement. Clinical outcomes were assessed through HbA1c,35,36 increase/decrease insulin by more than 15%,35 plaque index,36 gingival index,36 probing pocket depth,36 clinical attachment level,36 gingival recession,36 bleeding on probing,36 HbA1c,36 fasting plasma glucose,36 2-hour postprandial glucose,36 total cholesterol,36 triglycerides,36 high-density lipoprotein (HDL) cholesterol,36 and LDL cholesterol.36 Significant improvements were seen in plaque index,36 gingival index,36 probing pocket depth,36 HbA1c,36 and triglycerides.36 Significant improvements in several outcomes were observed in the Kiran et al36 trial but not in the Jones et al35 trial.
Vaccination. One study, with 2 interventions, dealt with vaccination (Table 5).37 Both interventions involved patient education signs in each exam room; however, 1 intervention also involved reminder stickers. A reminder sticker was placed by the nurse on the workup sheet that asked "Pneumovax needed?" Behavior change was assessed through the vaccination rate and revealed a significant change in the intervention with both the sign and reminder.37
Cardiovascular risk reduction. Nine studies represented by 10 articles13,17,18,34,38-43 dealt with cardiovascular risk reduction (Table 6). The interventions were multifaceted, including education,13,34,39-43 counseling,38,41 telephone contact,38 reminders,34 evidence-based algorithms,41 and medication management.18,38,42,43 Overall, all of the cardiovascular risk interventions that reported P values concerning cardiovascular risk led to at least 1 significant improvement in the various outcomes that were measured.13,17,34,38-43 Learning and, more specifically, "diabetes knowledge" were assessed in only 1 study and revealed a significant improvement.41
The assessed behavior outcomes included energy intake,39 fat (g/day),39 ratio of polyunsaturated to saturated fat,39 alcohol intake,39 physical activity,39 smoking,39 any exercise,38 aspirin use,34,41 angiotensin-converting enzyme (ACE) inhibitor use,34 daily aspirin therapy,18 and cigarette pack years.42,43 Of the 12 behavior outcomes, 5 (41.7%) had a significant improvement,34,39,41 and 1 did not report a P value.18 Commonly measured clinical outcomes included total cholesterol,13,38,39,41-43 body mass index (BMI),13,38,40,43 fasting serum glucose,38 HbA1c,13,34,38,40-43 systolic blood pressure,13,38,40-43 diastolic blood pressure,13,38,40-43 urinary albumin/creatinine ratio (ACR),38 overall HbA1c and serum lipids,13 triglycerides,13,38,40 HDL cholesterol,13,38,40,42,43 LDL cholesterol,13,38 overall BMI/waist-to-hip ratio,13 waist-to-hip ratio,13 overall blood pressure,13 overall plasma fatty acids,13 plasma fatty acids 18:2,13 plasma fatty acids 20:5,13 plasma fatty acids 22:6,13 overall flexibility,13 flexibility: sit and reach,13 flexibility: range of motion,13 blood pressure control,34 lipid levels,34 waist circumference,40 fasting plasma glucose,40 total cholesterol,40 triglycerides,40 serum creatinine level,42,43 creatinine clearance,42,43 proteinuria,42,43 heart rate,42,43 and HDL cholesterol level.42,43 Of the 56 between-group clinical outcomes, only 16 (28.6%) had a significant improvement.13,38,40-43 In addition, 4 clinical measures were reported as within-group P values, and all had significant improvement: HbA1c, serum cholesterol, systolic blood pressure, and diastolic blood pressure.17 Health status was assessed through such outcomes as overall quality of life,13 quality of life (Problem Areas in Diabetes [PAID] social summary),13 quality of life (PAID self-care summary),13 quality of life (Medical Outcomes Study [MOS]-12 physical health),13 quality of life (MOS-12 mental health),13 and treatment satisfaction.32 Of these 6 outcomes, 3 (50.0%) had significant improvement.13,41 Combined risk reduction. The 6 combined risk studies were represented in 9 articles (Table 7)14,15,44-50 and involved education,14,44-50 referrals,44 scheduling,44 algorithms,15 availability of consulting diabetologist,15 feedback,45,46 protocols or clinician recommendations,14,47-49 telephone contact45,46 in various areas including cardiovascular risk,14,15,44,47-49 eye exam,14,15,47-49 diet,47-49 foot care,14,44 physical activity,44 and glycemic control.15,50 Overall, each of the combined risk reduction intervention studies demonstrated a significant improvement in at least 1 outcome.
Of the 2 learning outcomes–knowledge14 and diabetes knowledge50–that were assessed, only knowledge had a significant improvement. The only health status outcome that was presented, attitudes to diabetes, did not reveal a significant improvement.50
The behavior outcomes that were assessed included ACE-K or angiotensin
receptor blockers
(ARBs),47-49
hydrochlorothiazide
(HCTZ),47-49
calcium channel blockers
(CCBs),47-49
β-blockers,47-49
In addition to the behavior outcomes, there were many clinical outcomes that were assessed, including incidence of blindness,14 fasting plasma glucose,14 body weight,14 HbA1c,15,44,47-50 sulphonylurea,50 metformin use,50 total cholesterol,15 fasting triglyceride,15 LDL cholesterol,15,44,47-49 HDL cholesterol,44 proteinuria,15 BMI,44,47-49 systolic blood pressure,44,47-49 diastolic blood pressure,44,47-49 estimated glomerular filtration rate (e-GFR),47-49 albumin/creatinine ratio,47-49 retinopathy,47-49 end-stage renal disease,47-49 cardiovascular disease events,47-49 strokes,47-49 coronary events,47-49 tryglicerides,44 and self-monitoring blood glucose.45,46 Of the 48 clinical outcomes, 19 (39.6%) revealed a significant improvement. A P value was not provided for 7 of the 48 clinical outcomes.
In this systematic review, diabetes self-management interventions were analyzed to reduce risks from studies published between 1990 and 2007. The 33 studies investigated a variety of interventions generalized into 7 risk reduction topics: smoking cessation, eye examination, foot care, oral health, vaccination, cardiovascular risk reduction, and comprehensive risk reduction. The studies commonly featured interventions with education or counseling sessions, telephone follow-up, reminders, and feedback. The educational materials included booklets, letters, newsletters, videotapes, and personal reports. The outcome measures varied greatly among the studies. The most commonly assessed outcomes in the studies were HbA1c (15 studies), cholesterol (10 studies), blood pressure (8 studies), and BMI (6 studies). Twenty-eight of the 33 studies (84.8%) indicated at least 1 outcome measure that was statistically significantly better in the intervention group than in the control group, indicating that those particular interventions are worthwhile. There were no findings indicating worse outcomes in any intervention study reviewed. This systematic review observed a decrease in the percentage of significantly improved outcomes as the measures progressed through the continuum from immediate (learning) (78.6%) to intermediate (behavior change) (50.0%) to postintermediate (clinical improvement) (38.5%) to long term (improved health status) (40.0%). A recent Centers for Disease Control and Prevention (CDC) study showed that disease management programs by physician groups, although associated with improved care processes, did not affect the intermediate outcomes that affect risk for complications.51 Modifying care processes can be easier than improving intermediate outcomes because process improvements can be applied to entire populations with diabetes. Altering intermediate outcomes requires identifying patients, targeting the interventions, and providing support for self-management skills. Multifaceted self-management programs for diabetes have been shown to produce clinically important benefits, but the specific elements of the programs that produce these benefits are difficult to determine from existing data.52-55 In this systematic review, only a modest benefit of multifaceted interventions over single interventions was observed: 16 of 18 studies (88.9%) with multifaceted interventions and 12 of 15 studies (80.0%) with single interventions led to significant improvement in outcomes at follow-up. Programs that encourage active engagement of patients and build self-efficacy have been shown to increase the effectiveness of self-management skills and to improve outcomes.56 Patients'sense of autonomy in managing their condition has been correlated with psychosocial and biologic outcomes related to effective diabetes self-management,57 suggesting that inclusion in diabetes education programs and/or training clinicians to interact with patients in a style that increases their support of patient autonomy may lead to improved diabetes outcomes. Only 1 of the studies in this systematic review measured self-efficacy.20 Self-management is particularly supportive when clinicians interact collaboratively with patients in developing a plan of care that considers both their clinical expertise and the concerns and priorities of the patient.58,59 The collaborative role operates to help patients understand what to expect in their health care and what is expected of them, including understanding of risk factor–reducing activities, and through this understanding to gain a sense of empowerment in managing their health condition. Patients may experience improved outcomes when there is greater agreement with their provider on both overall treatment goals and specific strategies to meet those goals.60 Understanding of self-care behaviors may have more influence on improved outcomes than either participatory decision making or the provider's communication style.61 To maximize control of their health condition, patients need basic data interpretation skills to understand the benefits and harms of actions to reduce disease-associated risks.62 No studies eligible for this systematic review looked specifically at improving patients' understanding of risk factors through access to medical record information. In an earlier study, however, Greenfield et al63 recognized the value of enabling patients to participate more effectively by preparing patients for a visit with the physician by reviewing with them their medical record using a diabetes algorithm. Intervention prompts helped the patients to be more involved in medical decision making and more effectively elicit information from the physician. The trial changed patient self-management behaviors and reduced HbA1c. This systematic review provides evidence of the benefits of educational self-management interventions for reducing risks in diabetes. It also identifies attributes of the studies that affect health outcomes for persons with diabetes. Studies that specify intervention content, patient sample, educators, materials used, and timing/dose can be used to quantify the impact on outcomes of risk-reducing interventions as well as guide the design of quality improvement efforts in diabetes where self-management is critical. Future research should include well-designed intervention studies focusing on diabetes risk reduction in areas where evidence is lacking, such as diabetic nephropathy, medical records, eye examination, oral health, and vaccination.
This research was supported by a Department of Veterans Affairs VISN 15 Research Award (Dr Boren) and by research assistance from the University of Missouri Center for Health Care Quality (Ms Gunlock). The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention and the Department of Veterans Affairs.
The Diabetes Educator, Vol. 33, No. 6,
1053-1077 (2007)
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-blockers,