EAL

TN: Telenutrition Interventions by Registered Dietitians (2012)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare the efficacy of two different ways of delivering nutritional therapy by videoconferencing. Research questions included:

Are the outcomes from a group diabetes education session delivered by video-conferencing improved by additional individual counseling sessions delivered by video-conferencing?
What is the level of patient satisfaction with video-conferencing as a method of receiving information about diabetes self-management?
How do patients perceive diabetes to affect their lives, what is their level of worry, and what is their level of satisfaction with life before and after diabetes education?

Inclusion Criteria:

Adult patients aged 18 years to 75 years, who had been previously diagnosed with type 2 diabetes.

Exclusion Criteria:

Patients who had profound visual or hearing impairment
Patients who did not have transportation to the clinic.

Description of Study Protocol:

Recruitment: Patients were a convenience sample of diabetes patients from the local rural community who were regularly treated at the clinic. They were invited to participate in the study by a single nurse via telephone.
Design: Randomized controlled trial
Blinding used: Implied with measurements.

Intervention

All participants received a single 90-minute group education session via video-conference
Patients were randomized to an Intervention Group (video-conferencing group session with two individual video-conferencing follow-ups) or a Control Group (video-conferencing group session only)
Subjects randomized to the intervention also received two additional individual follow-up sessions with a dietitian, four and eight weeks later.

Statistical Analysis

Mixed model, repeated-measures ANOVA was used to assess differences between groups and across time
Bivariate correlations were calculated to assess the relationship between groups and within groups for the survey data.

Data Collection Summary:

Timing of Measurements

Completed diabetes quality-of-life survey and initial blood sampling at baseline
Telemedicine patient satisfaction survey was completed immediately after the group session
At 16 weeks, final blood measurements were taken and a second diabetes quality-of-life survey was administered.

Dependent Variables

Hemoglobin A1c and LDL-cholesterol were assessed through standard laboratory methods
Diabetes quality-of-life and telemedicine patient satisfaction surveys.

Independent Variables

Patients were randomized to an Intervention Group (video-conferencing group session with two individual video-conferencing follow-ups) or a Control Group (video-conferencing group session only).

Description of Actual Data Sample:

Initial N

32 patients were randomized.

Attrition (Final N)

Complete data for 26 patients: 13 in each group; each group had eight men and five women.

Age

Intervention Group: 66 years
Control Group: 65 years.

Ethnicity

Not reported.

Other Relevant Demographics

Not reported.

Anthropometrics

There were no significant differences between age and BMI between groups.

Location

Kansas.

Summary of Results:

Key Findings

After 16 weeks, hemoglobin A1c decreased from 7.24% to 7.15% in the Intervention Group and from 6.70% to 6.51% in the Control Group
There was a 1% fall in hemoglobin A1c in the Intervention Group from pre- to post-assessment, although this was not significant
The Control Group showed a significantly larger fall in hemoglobin A1c levels than the Intervention Group (P=0.043)
Total cholesterol decreased in both groups, although not significantly
There was a positive correlation between the number of nutritional visits via video-conferencing and the hemoglobin A1c (R=0.40, P<0.05) and total cholesterol (R=0.12, P=0.056) at 16 weeks
In the diabetes quality-of-life surveys, both groups showed a decrease in the level of satisfaction with how they managed their diabetes between the initial and final assessment and an increase in how diabetes affected their lives between the initial and final assessment. Patients' level of worry increased between assessments.
For the Intervention Group only, there was a significant positive correlation at the initial assessment between the patients' level of satisfaction and how they perceived diabetes to affect their lives (R=0.66, P<0.001), however there was no correlation at the final assessment
Patient satisfaction with their telemedicine experience was very positive overall. Both control and intervention participants indicated that they would participate in video-conferencing nutritional counseling again
There was a positive correlation between how comfortable patients felt with video-conferencing and how convenient they perceived the encounter to be (R=0.82, P<0.001).

Mean Initial and Final Values of Hemoglobin A1c and Total Cholesterol

Variables	Initial HbA1c (%)	Final HbA1c (%)	Initial Cholesterol (mg/dL)	Final Cholesterol (mg/dL)
Intervention Group (N=13)	7.2±0.8	7.2±0.8	176.5±33.6	165.5±25.4
Control Group (N=13)	6.7±0.8	6.5±0.7	158.5±35.8	157.7±39.6

Author Conclusion:

The results suggest that providing nutritional therapy via video-conferencing may be useful in assisting patients to manage their conditions.

Funding Source:

Government:

Health Resources and Services Administration, Office for the Advancement of Telehealth

Reviewer Comments:

Small numbers of subjects in groups
Baseline differences in hemoglobin A1c between groups
No description of withdrawals.

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?		No
	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?		No
	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?	No
	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?		???
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	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?	???
	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?	N/A
	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?	???
	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?		???
	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?	???
	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)?	???
	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?	No
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