1. In this randomized control trial, providing positive support technique training to patient-supporter dyads was associated with greater patient confidence in managing diabetes.
2. However, increased patient supporter engagement did not lead to significant changes in physiological outcomes.
Evidence Rating Level: 1 (Excellent)
Diabetes is a highly prevalent health condition; however, more than 75% of adults with diabetes in the United States do not meet targets blood pressure, glycemic, or lipid control. Although support from a patient’s family and friends may help facilitate diabetic management, interventions which provided diabetes information to family supporters have not been shown to improve patient outcomes. However, the effectiveness of specific training in positive support techniques has not been tested.
This randomized control trial was conducted at two different United States Veterans Health primary care sites. Patients included in this study were aged 30 to 70 years with type 2 diabetes and hemoglobin A1c (HbA1c) greater than 8%, or systolic blood pressure (SBP) higher than 150mmHg. Patients with a life-limiting illness, serious mental illness, active substance use disorder, or those living in a nursing home were excluded. Each patient had an adult supporter. 239 patient-supporter dyads were randomized 1:1 to intervention or standard care and followed for 12 to 15 months. The intervention group received health coaching sessions focused on positive support techniques, while standard of care included general diabetes education materials. The primary outcome was change in patient confidence in managing diabetes, as measured by the Patient Activation Measure-13 (PAM-13) survey and diabetes-specific cardiac event risk score measured by the UK Prospective Diabetes Study (UKPDS). Secondary outcomes included changes in HbA1c, SBP, and diabetes self-management behavior.
Results demonstrated that dyads in the intervention group had greater improvement in PAM-13 score compared to the control group. However, there were no significant differences in 5-year cardiac event risk score or other physiological outcomes between groups. This study was limited by the generalizability given the demographic of patients within the Veterans Health system. Nonetheless, these results suggest that increasing patient supporters’ engagement in care of adults with diabetes is feasible and can improve key patient behavioral outcomes.
1. In this randomized controlled trial, community-based diet and exercise education led to improvement in osteoarthritis associated pain score.
2. Community-based diet and exercise regimen was more effective in lowering mean body weight and mean waist circumstance compared to attention control group.
Evidence Rating Level: 1 (Excellent)
Osteoarthritis (OA) is the most common cause of mobility and disability amongst the elderly. Since patients with OA live with symptoms for an average of 26.1 years, optimizing treatment of OA can have a significant impact on quality of life for this population. Although obesity has been identified as a modifiable risk factor for OA, the effectiveness of diet and exercise on relieving pain in OA has not been demonstrated in community-based settings.
This randomized control trial conducted in the United States consisted of 823 patients who were 50 years or older (77% women), had knee OA, and were overweight (classified as a body mass index ≥ 27). Patients with symptomatic coronary artery disease, type 1 diabetes, and active cancer were excluded. 414 patients were randomized to the intervention group, where they received in-person dietary counseling, provision of meal replacement supplements, and 60-minute group exercise sessions 3 days per week for 18 months. 409 patients were randomized to the control group and received in-person nutrition and health education, five times total. The primary outcome was self-reported Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score. Secondary outcomes measured included body weight, waist circumference, WOMAC function score, pain medication use, and quality of life score.
At the 18-month follow up, the intervention group had a statistically significant improvement in knee pain compared to the control group. Although it is unclear if the observed difference in knee pain score is of clinical importance, more patients in the intervention group achieved a clinically meaningful improvement in pain score compared to the control group. There were also significant improvements in secondary outcomes including body weight and function score in the intervention group. However, since nutritional supplements and gym access were provided as part of the trial protocol, the feasibility of replicating this study and providing such interventions as a part of osteoarthritis care is unclear.
1. In this multi-center randomized controlled trial, vitamin C supplementation in pregnant women, who were current smokers, was associated with better lung function in offspring at the age of five.
2. Additionally, vitamin C supplementation in pregnant smokers was also associated with decreased occurrence of wheezing in offspring.
Evidence Rating Level: 1 (Excellent)
Exposure to cigarette smoking in utero is a risk factor for impaired fetal lung development, decreased airway function, and development of asthma in the offspring. Supplementation of vitamin C for pregnant smokers has been shown to increase offspring airway function until the age of 12 months. However, the long-term effects of vitamin C supplementation during pregnancy on airway function have not been assessed.
This multi-center randomized control trial conducted in the United States included 251 pregnant patients aged 15 years or older. Participants were current smokers, defined as having smoked ≥1 cigarette in the last week, and were between 13- and 22-weeks’ gestation. Patients were excluded if they had complex medical conditions, were currently incarcerated, or had unstable methods of communication. 125 patients were randomized to receive vitamin C (500mg/d) and 126 received placebo. The primary outcome was forced mid-expiratory flow (FEF25-75) measured by spirometry at age five. Secondary outcomes included forced expiratory volume in 1 second (FEV1) and self-reported or clinically recorded occurrence of wheeze between four and six years old.
Results demonstrated that at five years old, children of pregnant smokers who received vitamin C had improved airway function, demonstrated by improvements in FEF25-75 and significantly decreased occurrence of wheeze, compared to the placebo group. This study was limited by potential misclassification of wheeze, which was assessed using survey responses from a parent or caretaker. However, the observed clinically important improvements and lack of adverse events associated with vitamin C supplementation after a long follow-up period are high, encouraging for the use of vitamin supplementation in pregnant smokers. Further trials to determine the optimal regimen and time of supplementation during initiation is still needed.
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