EAL

DM: Effectiveness of MNT Provided by RD/RDN (2015)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To conduct a one-year randomized clinical trial to evaluate a remote comprehensive diabetes self-management education (DSME) intervention, Diabetes TeleCare, administered by a dietitian and nurse/certified diabetes educator (CDE) in the setting of a federally qualified health center (FQHC) in rural South Carolina.

Inclusion Criteria:

GHb greater than 7%
Age >35 years
Having been seen within the last year at the community health center
Having a clinical diagnosis of diabetes
Being able and willing to participate in a one-year clinical trial.

Exclusion Criteria:

BMI <25kg/m² (based on self-reported height and weight)
Pregnancy
Acute and chronic illness that prevented safe participation in the study.

Description of Study Protocol:

Recruitment

Participants were recruited from three community health centers of a federally qualified health center (FQHC). The health centers were members of CareSouth Carolina and were >100 miles from the University of South Carolina. Sites were identified with assistance from the South Carolina Primary Health Care Association, a consortium of FQHCs across the state.

Design

Randomized clinical trial

Blinding used

Implied with measurements

Intervention

Diabetes TeleCare, a 12-month, 13-session (three individual, 10 group) curriculum delivered by a dietitian and nurse/certified diabetes educator (CDE) using telehealth strategies. Two sessions (one individual and one group) were held in the first month for an intervention "jump start". Three group sessions were conducted in person, and all others were conducted by interactive videoconferencing by the self-management education team (RD and the nurse/CDE) who were at the academic health center while the participants were at the primary care clinic. A licensed practical nurse coordinated in-person administrative functions at the clinic sites, served as a "hands-on" assistant and performed data collection. Participants completed logs recording results of self-monitored blood glucose, diet and physical activity. Participants were also offered retinal imaging during their annual eye exam.
Usual care consisted of one 20-minute diabetes education session, using American Diabetes Association materials, conducted individually at the time of randomization by the LPN. No other education/support for diabetes was given, except access to existing services at the community health centers.

Statistical Analysis

Original intended sample size was 200, based on power of 0.8, an alpha of 0.05, and an effect size of 0.5% change in GHb as the primary outcomes
Analyses were conducted using SAS version 9.1.
Linear mixed models for repeated measures tested for differences for each outcome, using group as the predictor of interest, controlling for potential confounders
Planned contrasts of group differences were used to identify significant changes between groups from baseline to six months and baseline to 12 months
Post hoc analyses, with recognized power limitations, were conducted separately on a subsample with data from the 24-month visit
Consistent with the original design criteria, P values <0.05 were regarded as significant.

Data Collection Summary:

Timing of Measurements

Measurements made at baseline, six and 12 months.

Dependent Variables

Glycated hemoglobin (GHb), LDL cholesterol and albumin-to-creatinine ratio assessed with immunoassay/absorption spectroscopy
Blood pressure measured three times using an Omron blood pressure monitor
Weight measured to the nearest 0.5lb using a Detecto balance beam scale
Height measured to the nearest 0.1cm using a Detecto stadiometer
BMI calculated
Waist circumference measurements made using non-tension flexible steel tape and recorded to the nearest 0.1cm.

Independent Variables

Assignment to Diabetes TeleCare or usual care

Control Variables

Demographics
Medical history
Medications
Knowledge, beliefs and behaviors related to diabetes
Usual diet
Physical activity (10-day pedometer log)
Visual function and self-report of eye exam in the last year
Health utilities
Cost.

Description of Actual Data Sample:

Initial N: 165 subjects completed two in-person screening visits and were randomized
- 85 to Diabetes TeleCare (72.9% female)
- 80 to Usual Care (76.3% female)
Attrition (final N):
- All 165 subjects completed the 12-month trial
- Brief 24-month measurement visit completed on two-thirds of the randomized sample, 58 subjects could not be included since their 24-month window had expired
Age: Mean age:
- 59.9±9.4 years in Diabetes TeleCare
- 59.2±9.3 years in usual care
Ethnicity:
- Diabetes Telecare: 75.3% African American/Other, 24.7% Non-Hispanic White
- Usual care: 72.5% African American/Other, 27.5% Non-Hispanic White
Other relevant demographics:
- Duration of diabetes was 8.5±6.6 years in Diabetes TeleCare, 10.3±8.1 years in usual care
- Overall, educational attainment and self-reported income were low, with two-fifths of the sample having Medicare/Medicaid
Anthropometrics: There were no significant differences between groups at baseline
Location: Rural South Carolina.

Summary of Results:

Key Findings

Mixed linear regression model results for repeated measures showed a significant reduction in glycated hemoglobin (GHb) in the Diabetes TeleCare group from baseline to six and 12 months (9.4±0.3, 8.3±0.3, and 8.2±0.4, respectively) compared with usual care (8.8±0.3, 8.6±0.3, and 8.6±0.3, respectively)
LDL cholesterol was reduced at 12 months in the Diabetes TeleCare group compared with usual care
Although not part of the original study design, GHb was reduced from baseline to 12 and 24 months in the Diabetes TeleCare group (9.2±0.4, 7.4±0.5, and 7.6±0.5, respectively) compared with usual care (8.7±0.4, 8.1±0.4, and 8.1±0.5, respectively) in a post hoc analysis of a subset of the randomized sample who completed a 24-month follow-up visit (P=0.05 from baseline to six months, P=0.004 from baseline to 12 months, and P=0.04 from baseline to 24 months).
There was no difference in improvement in blood pressure, BMI, waist circumference, or albumin-to-creatinine ratio.

Least Squares Means for Primary and Secondary Outcomes at Baseline and six and 12 Months by Randomization Status and P values from the Corresponding Mixed Model

Variables	Diabetes TeleCare	Usual Care	P value
GHb (percent)
Baseline	9.4±0.3	8.8±0.3
Six-month	8.3±0.3	8.6±0.3	0.003
12-month	8.2±0.4	8.6±0.3	0.004
LDL Cholesterol (mg/dL)
Baseline	103.0±6.5	102.5±6.2
Six-month	96.7±6.5	100.3±6.5	0.50
12-month	89.7±6.9	103.1±6.8	0.02

Author Conclusion:

In summary, multicomponent telehealth strategies were effectively utilized to successfully conduct a comprehensive remote DSME by physician extenders (CDE and dietitian) in a rural, underserved, and ethnically diverse primary-care setting, which improved metabolic control of adults with type 2 diabetes. In addition, this novel approach may be an effective and efficient means to extend the reach of a CDE or dietitian to areas and populations that would greatly benefit by improved metabolic control.

Funding Source:

Government:

NIH/NIDDK Grant R18DK067312

Reviewer Comments:

Brief 24-month measurement visit completed on two-thirds of the randomized sample, 58 subjects could not be included since their 24-month window had expired. Authors note that the sample was predominantly female, but this reflected the underlying demographics of the primary care practices.

Quality Criteria Checklist: Primary Research
Relevance Questions
	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

Validity Questions
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?	Yes
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)	No
	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?	N/A
	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?	N/A
	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?	Yes
	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)?	N/A
	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