Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus [ Time Frame: 3 months ]
Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care
Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus [ Time Frame: 12 months ]
Change in hemoglobin A1C for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care
Intervention costs of 1) medically tailored meals, 2) medically tailored meals + telehealth-delivered medical nutrition therapy, and 3) usual care [ Time Frame: 6 months ]
Cost of delivering usual care and MTM will be obtained from administrative billing data. Cost of delivering tele-MNT will be obtained from data logs which capture time preparing and delivering sessions.
Intervention costs of 1) medically tailored meals, 2) medically tailored meals + telehealth-delivered medical nutrition therapy, and 3) usual care [ Time Frame: 12 months ]
Cost of delivering usual care and MTM will be obtained from administrative billing data. Cost of delivering tele-MNT will be obtained from data logs which capture time preparing and delivering sessions.
Healthcare costs [ Time Frame: 6 months ]
Total participant health care cost will be obtained from the Healthshare Exchange of Southeast Pennsylvania (HSX), the regional health information exchange, or Jefferson billing and claims data. HSX captures administrative billing information (i.e., claims) for outpatient care, emergency department care, inpatient care, and post-acute care and prescription drugs.
Healthcare costs [ Time Frame: 12 months ]
Total participant health care cost will be obtained from the Healthshare Exchange of Southeast Pennsylvania (HSX), the regional health information exchange, or Jefferson billing and claims data. HSX captures administrative billing information (i.e., claims) for outpatient care, emergency department care, inpatient care, and post-acute care and prescription drugs.
Health care quality of life as measured by the EQ-5D-5L [ Time Frame: 6 months ]
Health utility will be measured using the EQ-5D-5L, which measures health-related quality of life by assessing 5 dimensions on a scale from 1-5. A summary index score is derived by applying an appropriate value set to the responses. The value sets provide weights to each health dimensions according to the preferences of the general population of a country or region. These values sets have been developed and verified by the EuroQol Research Foundation.
Health care quality of life as measured by the EQ-5D-5L [ Time Frame: 12 months ]
Health utility will be measured using the EQ-5D-5L, which measures health-related quality of life by assessing 5 dimensions on a scale from 1-5. A summary index score is derived by applying an appropriate value set to the responses. The value sets provide weights to each health dimensions according to the preferences of the general population of a country or region. These values sets have been developed and verified by the EuroQol Research Foundation.
Incremental Cost-Effectiveness Ratio (ICER) [ Time Frame: 6 months ]
The ICER is the measure of cost-effectiveness. It is calculated as the difference in cost (health care costs + intervention costs) between two strategies divided by the difference in health care related quality of life between two strategies.
Incremental Cost-Effectiveness Ratio (ICER) [ Time Frame: 12 months ]
The ICER is the measure of cost-effectiveness. It is calculated as the difference in cost (health care costs + intervention costs) between two strategies divided by the difference in health care related quality of life between two strategies.
Change in weight for patients with poorly controlled type 2 diabetes mellitus [ Time Frame: 3 months ]
Change in weight for patients with poorly controlled type 2 diabetes mellitus who receive 1)medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care
Change in weight for patients with poorly controlled type 2 diabetes mellitus [ Time Frame: 6 months ]
Change in weight for patients with poorly controlled type 2 diabetes mellitus who receive 1)medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care
Change in weight for patients with poorly controlled type 2 diabetes mellitus [ Time Frame: 12 months ]
Change in weight for patients with poorly controlled type 2 diabetes mellitus who receive 1)medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care
Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus as measured by The Diabetes Self Efficacy Scale [ Time Frame: 6 months ]
Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Diabetes Self Efficacy Scale is made up of 8 questions, all scored on a 10-point Likert scale. Each questions asks about the respondent’s confidence in performing an activity relative to diabetes. A response of 10 indicates total confidence, while a response of 1 indicates no confidence. The score for the scale is the mean of the eight items. Higher numbers are indicative of higher self-efficacy.
Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus as measured by The Diabetes Self Efficacy Scale [ Time Frame: 12 months ]
Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Diabetes Self Efficacy Scale is made up of 8 questions, all scored on a 10-point Likert scale. Each questions asks about the respondent’s confidence in performing an activity relative to diabetes. A response of 10 indicates total confidence, while a response of 1 indicates no confidence. The score for the scale is the mean of the eight items. Higher numbers are indicative of higher self-efficacy.
Change in self-care for patients with poorly controlled type 2 diabetes mellitus as measured by the Summary of Diabetes Self-Care Activities (SDSCA) [ Time Frame: 6 months ]
Change in self-care for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Summary of Diabetes Self-Care Activities (SDSCA) is a survey made up of 11 questions, all scored on a 7-point scale. Each question asks how many days in the last 7 days a diabetes related task was performed. The scale represents the number of days per week this task was performed and the respondent indicates the frequency with which they performed these tasks. The SDSCA assess five regimen areas: General Diet, Specific Diet, Exercise, Blood-Glucose Testing, Foot Care, and Smoking Status. Scores are calculated for each of the five regimen areas by finding the mean number of days each task was performed within each regimen. Higher scores indicate better management of diabetes self-care activities.
Change in self-care for patients with poorly controlled type 2 diabetes mellitus as measured by the Summary of Diabetes Self-Care Activities (SDSCA) [ Time Frame: 12 months ]
Change in self-care for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Summary of Diabetes Self-Care Activities (SDSCA) is a survey made up of 11 questions, all scored on a 7-point scale. Each question asks how many days in the last 7 days a diabetes related task was performed. The scale represents the number of days per week this task was performed and the respondent indicates the frequency with which they performed these tasks. The SDSCA assess five regimen areas: General Diet, Specific Diet, Exercise, Blood-Glucose Testing, Foot Care, and Smoking Status. Scores are calculated for each of the five regimen areas by finding the mean number of days each task was performed within each regimen. Higher scores indicate better management of diabetes self-care activities.
Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus as measured by Diabetes Quality of Life (DQoL) instrument [ Time Frame: 6 months ]
Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Diabetes Quality of Life (DQoL) instrument is made up of 15 questions, all scored on a 5-point Likert scale assessing either frequency (never – all the time) or satisfaction (very satisfied – very dissatisfied). Higher scores on DQOL items indicate higher frequency of negative impact of diabetes or higher dissatisfaction with diabetes care and quality of life.
Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus as measured by Diabetes Quality of Life (DQoL) instrument [ Time Frame: 12 months ]
Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus who receive 1) medically tailored meals and 2) medically tailored meals + telehealth-delivered medical nutrition therapy compared to usual care. The Diabetes Quality of Life (DQoL) instrument is made up of 15 questions, all scored on a 5-point Likert scale assessing either frequency (never – all the time) or satisfaction (very satisfied – very dissatisfied). Higher scores on DQOL items indicate higher frequency of negative impact of diabetes or higher dissatisfaction with diabetes care and quality of life.
Source: View full study details on ClinicalTrials.gov
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