MNT: RDN in Medical Team (2015)
Green BB, Anderson ML, Cook AJ, Catz S, Fishman PA, McClure JB, Reid RJ. e-Care for heart wellness: a feasibility trial to decrease blood pressure and cardiovascular risk. American Journal of Preventative Medicine, 2014; 46 (4): 368-377.PubMed ID: 24650839
- Recruited between 2010 and 2011 from four Group Health Medical Centers in Western Washington
- 35 to 69 years of age
- At least two years of enrollment with health system and one primary care visit in previous two years
- BP over 40mmHg systolic or over 90mmHg diastolic at the most recent primary care visit
- BMI over 26kg/m2
- Framingham CVD risk score between 10% and 25%
- Patients with BP over 140mmHg systolic or over 90mmHg diastolic at the screening visit were eligible to participate
- Informed consent provided.
Recruited between 2010 and 2011 from four Group Health Medical Centers in Western Washington.
- Participants were randomized to usual care (UC) or web-dietitian (WD) care using a stratified block randomization design
- UC participants were told during the baseline visit that BP was high and were encouraged to follow up with their physician for appropriate care. They also received a copy of laboratory results including Framingham 10-year CVD risk via patient website and by mail.
- No other interventions were provided to the UC Group
- WD participants received the same information as WD patients and were also provided with a scale, pedometer and home BP monitor and trained to use the devices. They were also scheduled to see a Group Health dietitian at their regular clinic for one visit and asked to complete a questionnaire routinely used by dietitian about physical activity, dietary habits, prior attempts to lose weight and tobacco and alcohol use. WD patients also completed a standard three-day food diary.
- During the in-person visit with WD patients, the dietitian obtained baseline information and created a plan to reduce CVD risk
- Planned follow-up occurred via secure messaging to report BP, weight, and fruit and vegetable intake as well as receiving ongoing feedback
- If needed, dietitians encouraged patients and their physicians to intensify antihypertensive and lipid-lowering medications
- Primary outcomes were change in systolic BP and weight loss of at least four kg at six months
- Feasibility outcomes included intervention utilization and satisfaction.
Intervention to decrease BP, CVD risk and weight (described above).
- Planned sample size of 100 randomized subjects provided 80% power to detect effect size of 0.6 standard deviation (SD) for the continuous outcomes assuming 90% follow-up at the six-month visit
- Linear regression models were used to estimate differences between groups in mean change from baseline for the continuous primary outcomes of BP, weight and CVD risk score, adjusted for sex and baseline value
- Generalized linear regression models with a log link were used to estimate intervention effects on binary outcomes, BP control (adjusting for sex, baseline systolic BP and BMI) and losing four kg (adjusted for sex and baseline weight)
- Analysis used complete case approach, excluding participants who did not return for a follow-up visit.
Timing of Measurements
- Systolic and diastolic BP, CVD risk and weight, as well as the proportion of patients with BP control (systolic BP of less than 140mmHg, diastolic less than 90mmHg) and weight loss of at least four kg, measured at baseline research visit prior to randomization and at six months after randomization
- Lab values drawn at baseline and six months.
- BP and weight measured in person
- CVD risk calculated using Framingham 10-year global CVD risk score questions
- Serum lipids
- Hemoglobin A1c
- Fasting blood glucose
- Total cholesterol
- High density lipoprotein (HDL-C) levels
- Hypertensive medication use and intensification
- Low density lipoprotein (LDL-C) levels
- Fruit and vegetable intake
- Body mass index (BMI)
- Waist circumference.
Independent VariablesIntervention to decrease CVD, BP and weight.
- Smoking status
- Baseline age
- Education level
- Martial status.
- Initial N: 101 subjects (42 females, 59 males)
- Attrition (final N): 90 subjects
- Age: 56.9±7.0 years
- Ethnicity: White, 85%; black, 5%; Asian, 3%; Other, 7%.
Other Relevant Demographics
- Education: 12 years or less or GED, 6%; some post high school, 32%; four-year college degree, 35%; graduate school, 26%. No significant difference between UC and WD Groups.
- Employed full-time: 74% overall. No significant difference between UC and WD Groups.
- Married, living with partner: 75% overall. No significant difference between UC and WD Groups.
- Weight was not significantly different between UC and WD Groups at baseline
- Waist circumference was not significantly different between UC and WD Groups at baseline.
- At the six-month follow-up, WD participants had lost significantly more weight than UC participants and were three times more likely to have lost at least four kg
- Both the UC and WD Groups had reductions in systolic BP from baseline, with 54% of the WD Group having controlled BP, compared to 40% in the UC Group (P=0.16)
- CVD risk decreased from baseline with an adjusted mean change in risk score of -4.1 in the WD Group, compared to -2.8 in the UC Group (P=0.1)
- Increases in daily fruit and vegetable intake were statistically significant in the WD Group (+2.3 servings), compared to the UC Group (zero servings; P<0.01)
- Physical activity levels were not statistically significant between groups
- Groups were similar in changes in LDL-C, HDL-C, hemoglobin A1c and fasting blood glucose
- Initiation and intensification of hypertensive medication occurred more often in the WD Group and BP medication adherence did not differ by group
- Quality of life measures for obesity and weight loss showed greater (not statistically significant) differences in the WD Group than the UC Group
- At six months, WD participants were statistically more likely to be satisfied with BP care, compared to UC participants (+1.3 points vs. -0.5 points) and patient assessment of chronic illness care (+2 points vs -0.1 points; P<0.05)
- WD participants statistically significantly more likely to report that they received patient-centered care consistent with CCM, compared to UC participants for all five domains and total score.
Adjusted Difference Between Groups
Systolic BP (mmHg) Unadjusted
Systolic BP (mmHg) Adjusted Mean Change
-11.4 (-15.4, -7.3)
-13.9 (-18.1, -9.8)
-2.6 (-8.6, 3.4)
Diastolic BP (mmHg) Unadjusted
|Diastolic BP (mmHg) Adjusted Mean Change||-6.6 (-9.2, -3.9)||-8.5 (-11.3, -5.8)||-2.0(-6.0, 2.0)||0.32|
|Weight (kg) Unadjusted||99.7 ± 17.4||97 ± 17.8||N/A||N/A|
|Weight (kg) Adjusted Mean Change||-0.5 (-1.6, 0.7)||-3.7 (-4.9, -2.5)||-3.2 (-5.0, -1.5)||<0.01|
|CVD Risk Score Unadjusted||13.8±4.8||11.4± 4.4||N/A||N/A|
|CVD Adjusted Mean Change||-2.8 (-3.9, -1.7)||-4.1 (-5.2, -3.0)||-1.3 (-2.9, 0.3)||0.1|
|BP Control Unadjusted||18± 39.1||24± 54.5||N/A||N/A|
|BP Adjusted Relative Risk||1.0 (ref)||1.39 (0.88, 2.21)||-||0.16|
|Number Lost ≥4 kg Weight (%)||5± 10.9||14± 31.8||N/A||N/A|
|Number Lost ≥4 kg Adjusted Relative Risk||1.0 (ref)||2.96 (1.16, 7.53)||-||0.02|
- The e-Care for Heart Wellness trial demonstrated a promising BP/CVD risk reduction intervention
- The WD intervention resulted in decreased weight, BP and CVD risk
- The study was feasible to conduct using Group Health-employed dietitians and existing EHR systems for secure e-mail communications and high rates of patient participation and satisfaction.
|Government:||National Heart, Lung and Blood Institute of NIH|
- Small sample size
- Lack of sufficient power to demonstrate whether reductions in BP and CVD risk were significant
- Short follow-up period
- Racially homogenous sample
- Self-reported measures.
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||Yes|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||Yes|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||Yes|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||Yes|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||Yes|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||No|
|3.||Were study groups comparable?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||Yes|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||Yes|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||Yes|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||N/A|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||N/A|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||Yes|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||Yes|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||No|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||Yes|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||N/A|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||N/A|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||Yes|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||N/A|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||Yes|
|6.6.||Were extra or unplanned treatments described?||Yes|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||Yes|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||No|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||Yes|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||Yes|
|7.7.||Were the measurements conducted consistently across groups?||Yes|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||Yes|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||Yes|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||Yes|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||No|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||Yes|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||Yes|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||Yes|
|10.||Is bias due to study's funding or sponsorship unlikely?||Yes|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|