EAL

TN: Telenutrition Interventions by Registered Dietitians (2012)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of this study was to describe the use of telemedicine for setting goals for behavior change and to examine the success in achieving these goals in rural under-served older adults with diabetes.

Inclusion Criteria:

Participants were Medicare beneficiaries at least 55 years of age with diabetes, who lived in federally-designated medically-underserved or health professional shortage areas of rural upstate NY
Fluent in either English or Spanish, however neither literacy nor prior computer experience was required.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment: Subjects were recruited from more than 200 PCP practices over an area of over 30,000 square miles in rural upstate New York
Design: Randomized controlled trial
Blinding used: Implied with measurements.

Intervention

Participants were enrolled in the telemedicine intervention of the Informatics for Diabetes Education and Telemedicine (IDEATel) project and participated in home televisits with nurse and dietitian educators every four to six weeks for two to six years
Behavior change goals were related to nutrition, physical activity, monitoring, diabetes health maintenance or use of the home telemedicine unit, were established at the conclusion of each televisit and assessed at the next visit.

Statistical Analysis

After each televisit, the number and types of behavior change goals set were entered into an Access database
For follow-up visits, assessment of achievement of each goal set at the prior visit was evaluated subjectively by the CDE and recorded as met, improved or no change
Descriptive statistics were used to assess frequency of responses to goal achievement
Data are presented as mean ±SD or number (percentage).

Data Collection Summary:

Timing of Measurements

At annual assessment visits, a nurse who was not involved in the intervention obtained physical measures such as height, weight and waist circumference and lab testing, such as hemoglobin A1c, fasting lipid panel and urine microalbumin:Cr and conducted a structured interview
Intervention subjects had an initial televisit with their assigned nurse case manager
Pertinent information such as medical and social history, medication regime, functional capacity, laboratory results and weight or exercise history was obtained at this visit
An initial nutrition counseling session was scheduled by the nurse case managers, based on participant interest and individual goals
The dietitian reviewed the history obtained by the nurse case manager before this visit.

Dependent Variables

Behavior change goals intended to help improve diabetes self-management
Goals achieved were assessed by self-report.

Independent Variables

Home telemedicine unit that video-conferences with a nurse case manager and dietitian. The initial visits with the nurse case manager and the RD were each 60 minutes.
A Samsung document camera (MFG) was available for use during all televisits to project nutrition education materials, display home BG patterns, food models and sample meal plans, to demonstrate BG monitoring and insulin injection techniques and to project materials relevant to other educational topics such as understanding hemoglobin A1c, targeting BG goals and foot care. All IDEATel televisits included the process of collaborative goal-setting, as nurse case managers and RDs established patient goals through the process of dialog, exploration and ongoing feedback.

Description of Actual Data Sample:

Initial N

610 participants: 44.9% male and 55.1% female.

Attrition (Final N)

Same as above.

Age

At baseline:

14.4% were 55 years to 64 years old
32.3% were 65 to 69 years old
24.4% were 70 to 74 years old
16.6% were 75 to 79 years old
12.3% were 80 years old or older.

Ethnicity

91.1% were white (non-Hispanic)
6.9% were black (non-Hispanic)
1.3% were Hispanic
0.7% were classified as Other.

Other Relevant Demographics

32% of participants had diabetes for more than five years
20.8% had diabetes for five to nine years
16.8% of participants had diabetes for 10 to 14 years
29.1% of participants had diabetes for 15 or more years.

Anthropometrics

Not described.

Location

Upstate New York.

Summary of Results:

Key Findings

The number of televisits with CDEs in which there was goal-setting varied from none to 114 per subject, with a mean of 33 televisits per subject
Over the course of the IDEATel trial in upstate New York, there were 18,355 televisits (9,089 male and 9,266 female) and 36,155 goals were set over more than six years
Approximately 8% of goals set by participants were home telemedicine unit-related, 20% were nutrition-related, 11% exercise-related, 42% related to monitoring and 19% related to general diabetes health maintenance
Overall, 68% of the behavioral goals were improved or met
The most common goals were related to monitoring, followed by diabetes health maintenance, nutrition, exercise and use of the telemedicine equipment
The greatest success was achieved for goals related to proper insulin injection technique and daily foot care
Elderly participants had the most difficulty achieving goals related to use of the computer
No gender differences in goal-achievement were observed.

Author Conclusion:

Televisits can be successfully used to collaboratively-establish behavior change goals to help improve diabetes self-management in under-served elderly rural adults.

Funding Source:

Government:

Cooperative Agreement Center for Medicare and Medicaid Services #95-C-90998

Reviewer Comments:

The authors did identify some limitations to the study
The intervention was multi-factorial and included medical management, so the specific effects of goal-setting on outcomes were not possible to evaluate
The assessment of achievement of goals was determined by participant self-report and as assessed by the nurse case manager and dietitian.

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?	???
	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)	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?		???
	7.1.	Were primary and secondary endpoints described and relevant to the question?	???
	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?		No
	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?	No
	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)?	No
	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