TN: Telenutrition Interventions by Registered Dietitians (2012)

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

This qualitative research focuses on understanding the experiences of elderly patients with diabetes, who participated in a telemedicine case management intervention, to better understand the barriers to success of telemedicine with the elderly.

Inclusion Criteria:
  • Participants in the Informatics for Diabetes Education and Telemedicine (IDEATel)
  • Ethnically-diverse sample of Medicare beneficiaries with diabetes, defined by physician's diagnosis and treatment with diet, insulin or oral agents
  • Living in medically under-served areas of New York City and rural, under-served Upstate New York
  • 55 years of age and older.
Exclusion Criteria:
  • Subjects with moderate or severe physical, cognitive or visual impairments
  • Subjects with severe comorbid disease.
Description of Study Protocol:
  • Recruitment: Participants were enrolled through primary care providers
  • Design: Randomized controlled trial. Subjects were randomized to telemedicine case management or usual care in a 1:1 ratio by the study coordinating center.
  • Blinding used: Not used.

Intervention

  • Case management intervention delivered via a web-enabled home telemedicine computer unit that allowed them to teleconference with a nurse case manager and dietitian, upload blood glucose and blood pressure data and access educational materials and individualized data displays
  • Subjects and providers participated in videoconferences every four to six weeks (with significant need, every two weeks) to educate patients, facilitate goal-setting and self-management and to discuss concerns
  • Supportive interactions provided contact tailored to individual needs
  • Under endocrinologist supervision, nurse case managers consulted with primary care providers who made all treatment decisions.

Statistical Analysis

The principal analytic tool in the study was constant comparison: By using the constant comparative method, incidents and phenomena across subjects were compared for similarities and differences in properties, dimensions and processes.

Data Collection Summary:

Timing of Measurements

Telephone interviews were conducted with elderly patients with diabetes prior to and six and 12 months after participating in a case management intervention.

Dependent Variables

  • Satisfaction and usefulness assessed with the 26-item Telemedicine Satisfaction and Usefulness Questionnaire
  • Other patient perspectives from telephone interviews. A trained research assistant performed semi-structured interviews over the telephone with participants. A majority of interviews lasted less than 30 minutes.

Independent Variables

  • Case management intervention delivered via a Web-enabled home telemedicine computer unit that allowed them to teleconference with a nurse case manager and dietitian, upload blood glucose and blood pressure data and access educational materials and individualized data displays
  • Subjects and providers participated in video-conferences every four to six weeks (with significant need, every two weeks) to educate patients, facilitate goal-setting and self-management and to discuss concerns
  • Supportive interactions provided contact tailored to individual needs
  • Under endocrinologist supervision, nurse case managers consulted with primary care providers who made all treatment decisions.
Description of Actual Data Sample:

Initial N

  • 1,220 subjects enrolled in the rural Upstate New York component
  • 330 enrolled during Phase Two
  • 40 IDEATel participants in the Upstate Group, who were consecutively randomized to the Intervention Group were approached to participate at the time of their enrollment in IDEATel: 36 consented to participate.

Attrition (Final N)

  • 33 were interviewed prior to the intervention
  • 33 participated in the six-month interviews
  • 29 were interviewed at 12 months
  • 25 participants participated in all three interviews.   

Age

Mean, 67.93±6.05 years.

Ethnicity

  • 38 subjects were white, non-Hispanic
  • Two subjects were classified as "other."

Anthropometrics

Baseline differences between groups were not discussed.

Location

New York.

Summary of Results:

Key Findings

Initial interviews

  • Qualitative analyses revealed that patients enrolled primarily because healthcare providers encouraged them. This was the most significant factor in raising their interest in the program.
  • A large sub-set of participants also described a desire to "help control my diabetes" or "help others/find cure"
  • Their goals were to improve diabetes control, with few expectations of an effect on emotional health or family relationships
  • There were only eight comments regarding any obstacles or fears relating to the program, five of which addressed personal issues participants struggle with in their lives (overall health, lack of education, personal habits)
  • Overall, participants' responses to the initial interview questions suggest that they were drawn to the program because they felt a strong need to better manage diabetes symptoms; they did not feel overwhelmed by the use of technology; and they had specific expectations regarding how the program can improve their physical health.

Follow-up interviews

  • Across both follow-up interviews, participants described how much they appreciated the program's focus on monitoring and recording readings and the supportive and helpful interaction with the IDEATel diabetes educators and nurses
  • In terms of obstacles, participants identified the most common barrier as computer or equipment problems, ranging from concrete hardware or software problems to difficulty operating the blood pressure monitor, to running out of supplies
  • Participants reported noticing and being happy about positive changes in their eating habits and weight, glucose readings and insulin use, monitoring, activity level, blood pressure and overall health across both follow-up interviews
  • After involvement, they particularly valued the emphasis on monitoring of health outcomes and supportive contact with diabetes staff to encourage, remind and answer questions.
Author Conclusion:

In summary, we hear once again that diabetes is a difficult disease to manage and that patients need supportive help. By using telemedicine delivery of an intervention, we may be better able to provide the needed support and consistent monitoring needed, especially for medically under-served patients who are often more alone in dealing with diabetes. The patients tell us several things that can guide development of similar interventions:

  • That it is critical to enlist the support and influence of their healthcare providers and this may be especially true for a new technology like telemedicine
  • That staff who deliver the intervention should be chosen for their ability to emotionally connect to their patients as well as for their clinical knowledge and expertise. Training in interpersonal skills may help staff who are often more medically-oriented to address relationship issues too.
  • That some formal mechanism to promote self-monitoring and accountability for patients is another key to their involvement and satisfaction.

In future research, we should include more diverse samples of patients with diabetes and compare different interventions in order to determine whether these implications hold across groups.

Funding Source:
Government: Centers for Medicare and Medicaid Services
Reviewer Comments:
  • Small numbers of subjects participated in interviews and the subject pool was not randomly sampled
  • Baseline differences between groups were not discussed.
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? ???
  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? ???
  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? ???
  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.) No
  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? 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? 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)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  8.6. Was clinical significance as well as statistical significance reported? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
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