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TN: Telenutrition Interventions by Registered Dietitians (2012)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To determine whether diabetes education can be provided as effectively through telemedicine technology as through in-person encounters with diabetes nurse and nutrition educators.

Inclusion Criteria:
  • Patients with diabetes, aged 18 to 75 years, who presented to the Joslin Diabetes Center at SUNY Upstate Medical University in Syracuse, New York and to satellite offices in Oswego, New York and Oneida, New York
  • Subjects must not have had diabetes education for at least one year
  • Able to read, understand and sign the consent document.
Exclusion Criteria:
  • History of not keeping doctor's appointments
  • Had profound visual or hearing impairment
  • Had psychiatric illness not controlled with medications
  • Had a history of illicit drug use or heavy alcohol consumption (more than four alcoholic drinks per day)
  • Not willing to travel to Syracuse, New York, if randomized to receive diabetes education in person.
Description of Study Protocol:
  • Recruitment: Recruited from the Joslin Diabetes Center at SUNY Upstate Medical University in Syracuse, New York and satellite offices in Oswego, New York and Oneida, New York
  • Design: Randomized controlled trial. Subjects were randomized into groups using a stratified randomization procedure for random permuted blocks.
  • Blinding used: Implied with measurement. Treating physician was unaware to which group the subjects were randomized.

Intervention

  • Subjects were randomized to receive diabetes education in person (Control Group) or telemedicine (Telemedicine Group)
  • Subjects either met with the diabetes nurse educator and dietitian in person at the Joslin Diabetes Center in Syracuse or met with them through video-conferencing at one of the telemedicine sites located in Oswego, Oneida or an off-site location in Syracuse
  • Education consisted of three consultative visits and used the same information and educational materials:
    • The first visit included one-hour consultations with the diabetes nurse educator and the dietitian
    • There were two 30-minute follow-up appointments with the educator and dietitian at four to six weeks (Visit Two) and at eight to 12 weeks (Visit Three), after the initial visit.

Statistical Analysis

  • Two-factor mixed-model ANOVA statistic was used to compare HbA1c values observed before and after diabetes education
  • Analyses of secondary end-points were performed using similar 2 x 3 ANOVA testing, crossing pre- and post-time-points with in-person or telemedicine conditions
  • Further analysis of the data using BMI and age as covariates was undertaken because these baseline differences were significant.
Data Collection Summary:

Timing of Measurements

Measurements made at baseline, immediately after completion of diabetes education and three months after the third educational visit.

Dependent Variables

  • Glycemic control through HbA1c
  • Fasting lipid profile
  • Sitting resting blood pressure
  • Weight, height, BMI
  • Patient satisfaction and psychosocial functioning assessed through questionnaires
    • Problem Areas in Diabetes (PAID) scale
    • Diabetes Quality of Life (DQOL) scale
    • Appraisal of Diabetes Scale (ADS)
    • Diabetes Treatment Satisfaction Questionnaire (DTSQ)
    • Telemedicine Patient Satisfaction Survey.

Independent Variables

Randomization to in-person (Control Group) or telemedicine (Telemedicine Group).

Control Variables

  • BMI
  • Age
  • Demographic information.
Description of Actual Data Sample:

Initial N

56 subjects randomized: 27 in the In-Person Group and 29 in the Telemedicine Group.

Attrition (Final N)

  • 46 subjects completed the trial (82%), 22 in the In-Person Group (13 males, nine females) and 24 in the Telemedicine Group (eight males, 16 females)
  • There were five dropouts from each group. Reasons for discontinuing participation were concurrent illness (N=1), lack of time to participate (N=8) and inability to keep subsequent appointments (N=1).
  • Measurements were not made in all subjects.

Age 

  • In-Person Group: Mean, 61.37±8.95 years
  • Telemedicine Group: Mean, 53.95±10.08 years.

Ethnicity

  • 95% Caucasian
  • 5% African-American.

Other Relevant Demographics

  • 41% completed high school
  • 47% were college graduates
  • 6% graduated from high school and attended college, but did not graduate.

Anthropometrics

Significant differences between groups in age and BMI.

Location

New York.

Summary of Results:

Key Findings

  • Patient satisfaction was high in the Telemedicine Group
  • Problem Areas in Diabetes Scale scores improved significantly with diabetes education (adjusted P<0.05, before vs. immediately after education and three months after education) and the attainment of behavior-change goals did not differ between groups
  • With diabetes education, HbA1c improved from 8.6±1.8% at baseline to 7.8±1.5% immediately after education and 7.8±1.8% three months after the third educational visit (unadjusted P<0.001, P=0.089 adjusted for BMI and age), with similar changes in the Telemedicine and In-Person Groups
  • Adjusted analyses found no significant differences between groups in terms of lipid profile, BMI or blood pressure
  • In terms of the costs of the telemedicine intervention, the cost of the necessary equipment at the diabetes center was $5,078 and at one of the telemedicine sites was $6,340. In addition, the line charges amounted to a monthly maintenance ISDN line charge of $37 and a charge of $14 per hour of line use. Costs of the in-person intervention were not reported.  

Results of Measures of Glycemic Control, Psychosocial Functioning, and Satisfaction

Variables

 Baseline Immediately After Education

3 Months After Education

HbA1c

 In-Person, N=18
8.6±1.6
7.8±1.3
7.6±1.3
Telemedicine, N=19
8.7±2.1
7.8±1.6
7.8±2.2
Total, N=37
8.6±1.8
7.8±1.5
7.8±1.8
LDL Cholesterol

 

 In-Person, N=19
2.93±0.74
2.79±0.68
2.67±0.97
Telemedicine, N=15
2.84±0.98
2.47±0.86
2.55±0.97
Total, N=34

2.89±0.84

2.65±0.77

2.62±0.96
PAID Scale In-Person, N=17
35.8±23.4
33.6±17.0
29.4±17.8
Telemedicine, N=14
37.4±25.8
28.1±22.0
27.4±17.9
Total, N=31
36.6±24.1
31.1±19.2
28.6±17.6
ADS Scale In-Person, N=19
20.1±4.7
19.3±2.7
18.6±4.2
Telemedicine, N=15
20.1±4.1
17.1±3.7
18.6±3.5
Total, N=34
20.1±4.4
18.3±3.3
18.6±3.9
Treatment Satisfaction In-Person, N=16
23.8±7.9
30.7±3.8
29.1±5.3
Telemedicine, N=12
22.8±8.6
30.9±4.2
31.3±4.2
Total, N=28
23.4±8.1
30.8±3.9
30.0±5.1
DQOL Scale In-Person, N=19
61.2±15.0
69.6±11.8
68.4±13.5
Telemedicine, N=16
63.4±13.0
71.4±12.2
69.1±11.0
Total, N=35
62.2±13.9
70.4±11.8
68.7±12.3

Author Conclusion:
  • Diabetes education via telemedicine and in-person was equally effective in improving glycemic control and both methods were well accepted by patients
  • Reduced diabetes-related stress was observed in both groups
  • These data suggest that telemedicine can be successfully used to provide diabetes education to patients.
Funding Source:
Government: New York State Department of Health
Industry:
Bayer Institute for Health Care Communication, Bell Atlantic
Pharmaceutical/Dietary Supplement Company:
Other:
University/Hospital: SUNY Upstate Medical University
Reviewer Comments:
  • There were significant differences in age and BMI between groups at baseline, but these were controlled for in the statistical analysis
  • Measurements were not made in all subjects
  • Authors note the following limitations:
    • Sample size was limited, study not powered to detect small differences
    • Baseline differences in age and BMI between groups
    • Lack of Non-intervention usual care group
    • Goal-assessment was obtained by clinicians and data are limited, given the motivation for positive responses on both the patients' and providers' part. Nurse educators changed during the study period, while the dietitian remained the same.
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? ???
  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? ???
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) Yes
  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? 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? N/A
  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? N/A
  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? 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? ???
  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? 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